Intestinal Research

Original Articles

Impact of filgotinib on health-related quality of life over 3 years in Japanese patients with ulcerative colitis: a post hoc analysis of the SELECTION and SELECTION long-term extension trials: Katsuyoshi Matsuoka, Stefan Schreiber, Erina Hata, Toshihiko Kaise, Toshifumi Hibi; Received September 9, 2025 Accepted December 7, 2025 Published online March 4, 2026; DOI: https://doi.org/10.5217/ir.2025.00219 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
This post hoc analysis of the phase 2b/3 SELECTION (NCT02914522) study and its long-term extension (SELECTIONLTE; NCT02914535) evaluated the impact of filgotinib 200 mg (FIL200) on health-related quality of life (HRQoL) and work productivity in Japanese patients with ulcerative colitis over 3 years.
Methods
Patients in SELECTION were randomized to FIL200, filgotinib 100 mg, or placebo (PBO) during the induction phase. Week-10 responders were re-randomized to continue assigned treatment or PBO in the 47-week maintenance phase. Patients who completed the SELECTION induction and maintenance phases (completers) and week-10 non-responders could enter SELECTIONLTE. HRQoL and work productivity were assessed using EQ 5-dimension (EQ-5D), EQ visual analog scale, Inflammatory Bowel Disease Questionnaire (IBDQ), 36-item Short Form Health Survey (SF-36), and Work Productivity and Activity Impairment (WPAI) questionnaires at week 10 (FIL200 vs. PBO), and at week 10 and years 1–3 (completers and non-responders who received only FIL200 in SELECTION+SELECTIONLTE).
Results
Proportions of patients with minimal clinically important differences (MCIDs) at week 10 were higher with FIL200 versus PBO for IBDQ total score (77% vs. 54%), SF-36 mental component summary (58% vs. 21%), and SF-36 physical component summary (54% vs. 36%). All measures (except WPAI absenteeism) showed mean score changes from baseline at week 10 in the direction of improved HRQoL with FIL200 versus PBO. MCID rates were maintained in completers up to 3 years and increased notably in non-responders (except WPAI absenteeism and EQ-5D) from week 10 to years 1–3.
Conclusions
FIL200 treatment was associated with sustained improvements in HRQoL and work productivity over 3 years in Japanese patients with ulcerative colitis, consistent with the overall SELECTION and SELECTIONLTE trial populations.

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Week 2 remission with vedolizumab as a predictor of long-term remission in patients with ulcerative colitis: a multicenter, retrospective, observational study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi; Received April 9, 2024 Accepted April 6, 2025 Published online July 14, 2025; DOI: https://doi.org/10.5217/ir.2025.00047 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Vedolizumab (VDZ), a gut-selective monoclonal antibody for ulcerative colitis (UC) treatment, has no established biomarkers or clinical features that predict long-term remission. Week 2 remission, a potential predictor of long-term remission, could inform maintenance treatment strategy.
Methods
This retrospective, observational chart review included patients with UC in Japan who initiated VDZ between December 2018 and February 2020. Outcome measures included 14- and 54-week remission rates in patients with week 2 and non-week 2 remission (remission by week 14), 54-week remission rates in patients with week 14 remission and primary nonresponse, and predictive factors of week 2 and week 54 remission (logistic regression).
Results
Overall, 332 patients with UC (176 biologic-naïve and 156 biologic-non-naïve) were included. Significantly more biologic-naïve than biologic-non-naïve patients achieved week 2 remission (36.9% vs. 28.2%; odds ratio [OR], 1.43; 95% confidence interval [CI], 1.05–1.94; P= 0.0224). Week 54 remission rates were significantly different between week 14 remission and primary nonresponse (both groups: P< 0.0001), and between week 2 and non-week 2 remission (all patients: OR, 2.41; 95% CI, 1.30–4.48; P= 0.0052; biologic-naïve patients: OR, 2.40; 95% CI, 1.10–5.24; P= 0.0280). Week 2 remission predictors were male sex, no anti-tumor necrosis factor alpha exposure, and normal/mild endoscopic findings. Week 54 remission was significantly associated with week 2 remission and no tacrolimus use.
Conclusions
Week 2 remission with VDZ is a predictor of week 54 remission in patients with UC. Week 2 may be used as an evaluation point for UC treatment decisions. (Japanese Registry of Clinical Trials: jRCT-1080225363)

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Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
Jung Min Moon
Intestinal Research.2026; 24(1): 3. CrossRef

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Ulcerative colitis disease severity affects the speed of symptom relief under filgotinib treatment: a post hoc analysis of the phase 2b/3 SELECTION study: Masayuki Saruta, Silvio Danese, Yoshie Takatori, Toshihiko Kaise, Christine Rudolph, Marc Ferrante, Toshifumi Hibi; Received October 23, 2024 Accepted April 28, 2025 Published online June 30, 2025; DOI: https://doi.org/10.5217/ir.2024.00169 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Filgotinib is an oral, once-daily, Janus kinase 1 preferential inhibitor approved for the treatment of ulcerative colitis (UC). This study aimed to assess symptomatic response with filgotinib 200 mg (FIL200) according to disease severity using baseline partial Mayo Clinic Score (pMCS).
Methods
In the phase 2b/3 SELECTION study (NCT02914522), adults with moderate-to-severe UC were randomized to receive FIL200, filgotinib 100 mg, or placebo for 11 weeks in induction studies A (biologic-naive) and B (biologic-experienced). In this post hoc analysis, symptomatic remission (Mayo rectal bleeding subscore of 0 and stool frequency subscore ≤ 1) rates were assessed daily from baseline to day 15 and fortnightly from week 2 to week 10 by baseline pMCS (pMCS ≥ 7, pMCS < 7) in patients who received induction FIL200.
Results
Of those who received FIL200 in induction studies A and B, 90 and 148 patients had a pMCS ≥ 7, and 155 and 114 had a pMCS < 7, respectively. Symptomatic remission rates were generally significantly higher in the pMCS < 7 than ≥ 7 group from day 2–15 (day 2: 8.4% vs. 1.1%, P= 0.009 [induction study A]; 8.8% vs. 0.7%, P= 0.004 [induction study B]). However, by week 10, there was no longer a significant difference in the rates between the pMCS ≥ 7 and < 7 groups (43.3% vs. 54.8%, P= 0.124 [induction study A]; 26.4% vs. 39.5%, P= 0.099 [induction study B]).
Conclusions
Symptomatic response to FIL200 occurred more rapidly in the less severe disease groups than in the more severe disease groups; however, regardless of disease severity, both groups benefited from continued FIL200 treatment.

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The duration of prior anti-tumor necrosis factor agents is associated with the effectiveness of vedolizumab in patients with ulcerative colitis: a real-world multicenter retrospective study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Minoru Matsuura, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Mary Cavaliere, Kaori Ishiguro, Jovelle L Fernandez, Toshifumi Hibi; Received August 9, 2024 Accepted March 20, 2025 Published online June 4, 2025; DOI: https://doi.org/10.5217/ir.2024.00126 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Previous literature suggests that the response of patients with ulcerative colitis to vedolizumab may be affected by previous biologic therapy exposure. This real-world study evaluated vedolizumab treatment effectiveness in biologicnon-naïve patients.
Methods
This was a multicenter, retrospective, observational chart review of records from 16 hospitals in Japan (December 1, 2018, to February 29, 2020). Included patients who had ulcerative colitis, were aged ≥ 20 years, and received at least 1 dose of vedolizumab. Outcomes included clinical remission rates from weeks 2 to 54 according to prior biologic exposure status and factors associated with clinical remission up to week 54.
Results
A total of 370 eligible patients were included. Clinical remission rates were significantly higher in biologic-naïve (n=197) than in biologic-non-naïve (n=173) patients for weeks 2 to 54 of vedolizumab treatment. Higher clinical remission rates up to week 54 were significantly associated with lower disease severity (partial Mayo score ≤ 4, P= 0.001; albumin ≥ 3.0, P= 0.019) and the duration of prior anti-tumor necrosis factor α (anti-TNFα) therapy (P= 0.026). Patients with anti-TNFα therapy durations of < 3 months, 3 to < 12 months, and ≥ 12 months had clinical remission rates of 28.1%, 32.7%, and 60.0%, respectively (P= 0.001 across groups).
Conclusions
The effectiveness of vedolizumab in biologic-non-naïve patients was significantly influenced by duration of prior anti-TNFα therapy. (Japanese Registry of Clinical Trials: jRCT-1080225363)

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Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
Jung Min Moon
Intestinal Research.2026; 24(1): 3. CrossRef
Long-Term Outcomes and Prognostic Factors for Vedolizumab-Treated Japanese Patients with Ulcerative Colitis
Shinya Fukushima, Takehiko Katsurada, Takahiro Ito, Atsuo Maemoto, Fumika Orii, Toshifumi Ashida, Masanao Nasuno, Hiroki Tanaka, Katsuyoshi Ando, Mikihiro Fujiya, Yoshihiro Yokoyama, Satoshi Motoya, Hiroshi Nakase
Inflammatory Intestinal Diseases.2025; 11(1): 1. CrossRef

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Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: results from a phase 2 dose-ranging study: Ken Takeuchi, Hiroshi Nakase, Tadakazu Hisamatsu, Katsuyoshi Matsuoka, Shoko Arai, Hirotoshi Yuasa, Motoki Oe, Ryosuke Ono, Michael Keating, Guibao Gu, Krisztina Lazin, Aoibhinn McDonnell, Koki Fukuta, Toshifumi Hibi; Received December 17, 2024 Accepted March 4, 2025 Published online April 25, 2025; DOI: https://doi.org/10.5217/ir.2024.00213 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). However, its efficacy, safety, and the appropriate dosage have not been extensively investigated in the Japanese population.
Methods
This phase 2, multicenter, randomized, double-blind, placebo-controlled dose-ranging, 12-week trial was carried out among Japanese patients with moderately to severely active UC. Patients were randomized 1:1:1 to receive etrasimod 1 mg once daily (QD), etrasimod 2 mg QD, or placebo. The primary efficacy endpoint was the proportion of patients achieving clinical remission at week 12. Secondary efficacy endpoints and treatmentemergent adverse events (TEAEs) were also investigated. Efficacy endpoints were presented as proportions of patients achieving each outcome.
Results
Overall, 17, 19, and 18 patients received etrasimod 1 mg QD, etrasimod 2 mg QD, and placebo, respectively. One patient receiving etrasimod 1 mg (6.7%), 5 patients receiving etrasimod 2 mg (26.3%), and no patients receiving placebo (0%) achieved clinical remission. More patients receiving etrasimod versus placebo achieved secondary endpoints, except endoscopic normalization, at week 12. TEAEs were experienced by 9 patients receiving etrasimod 1 mg (52.9%), 13 patients receiving etrasimod 2 mg (68.4%), and 10 patients receiving placebo (55.6%). None of the TEAEs were serious and none experienced by patients receiving etrasimod led to treatment discontinuation.
Conclusions
Overall, etrasimod 2 mg QD for up to 12 weeks appeared efficacious and safe in these Japanese patients with moderately to severely active UC. All TEAEs were mild to moderate in severity. (ClinicalTrials.gov: NCT05061446)

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IBD

Factors affecting 1-year persistence with vedolizumab for ulcerative colitis: a multicenter, retrospective real-world study: Taku Kobayashi, Tadakazu Hisamatsu, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Ken Takeuchi, Sakiko Hiraoka, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Masaaki Shimada, Nobuaki Kuno, Jovelle L. Fernandez, Kaori Ishiguro, Mary Cavaliere, Hisato Deguchi, Toshifumi Hibi; Intest Res 2026;24(1):64-75. Published online January 16, 2025; DOI: https://doi.org/10.5217/ir.2024.00063

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The objectives of this real-world study were to determine 1-year persistence with vedolizumab in patients with ulcerative colitis and to evaluate factors contributing to loss of response.
Methods
In this multicenter, retrospective, observational chart review, patients with moderately to severely active ulcerative colitis who received ≥ 1 dose of vedolizumab in clinical practice at 16 tertiary hospitals in Japan (from December 2018 through February 2020) were enrolled.
Results
Persistence with vedolizumab was 64.5% (n = 370); the median follow-up time was 53.2 weeks. Discontinuation due to loss of response among initial clinical remitters was reported in 12.5% (35/281) of patients. Multivariate analysis showed that concomitant use of tacrolimus (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.00–7.62; P= 0.050) and shorter disease duration (OR for median duration ≥ 7.8 years vs. < 7.8 years, 0.33; 95% CI, 0.13–0.82; P= 0.017) were associated with discontinuation due to loss of response. Loss of response was not associated with prior use of anti-tumor necrosis factor alpha therapy, age at the time of treatment, disease severity, or concomitant corticosteroids or immunomodulators. Of the 25 patients with disease duration < 1 year, 32.0% discontinued due to loss of response.
Conclusions
Persistence with vedolizumab was consistent with previous reports. Use of tacrolimus and shorter disease duration were the main predictors of decreased persistence.

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Interpreting vedolizumab persistence: lessons from real-world trajectories in ulcerative colitis
Jung Min Moon
Intestinal Research.2026; 24(1): 3. CrossRef
Real‐World Effectiveness and Safety of Vedolizumab in Patients ≥ 70 Versus < 70 Years With Ulcerative Colitis: Multicenter Retrospective Study
Tadakazu Hisamatsu, Taku Kobayashi, Satoshi Motoya, Toshimitsu Fujii, Reiko Kunisaki, Tomoyoshi Shibuya, Minoru Matsuura, Sakiko Hiraoka, Ken Takeuchi, Hiroshi Yasuda, Kaoru Yokoyama, Noritaka Takatsu, Atsuo Maemoto, Toshiyuki Tahara, Keiichi Tominaga, Ma
Journal of Gastroenterology and Hepatology.2025; 40(6): 1435. CrossRef
Increasing age at diagnosis raises malignancy risk and aminosalicylate intolerance influences therapeutic strategies in ulcerative colitis: a multicenter I‑BRITE cohort study
Shintaro Akiyama, Yuka Ito, Mamiko Shiroyama, Satoshi Suzuki, Masanori Ochi, Toshiro Kamoshida, Hiroshi Kashimura, Junichi Iwamoto, Rie Saito, Tsuyoshi Kaneko, Kazuto Ikezawa, Yoshinori Hiroshima, Junji Hattori, Takashi Mamiya, Satoshi Fukuda, Kazuho Iked
Journal of Gastroenterology.2025; 60(10): 1259. CrossRef
Mayo Endoscopic Subscore at Week 24 Is a Predictor of Future Loss of Response to Vedolizumab in Patients with Ulcerative Colitis in Clinical Remission
Daisuke Saito, Minoru Matsuura, Hiromu Morikubo, Noritaka Hibi, Haruka Komatsu, Noriaki Oguri, Takeshi Fujima, Haruka Wada, Ryota Ogihara, Tatsuya Mitsui, Mari Hayashida, Jun Miyoshi, Teppei Omori, Tadakazu Hisamatsu
Inflammatory Intestinal Diseases.2025; 10(1): 387. CrossRef

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Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study: Taku Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-ichi Iwayama, Toshifumi Hibi; Intest Res 2025;23(2):157-169. Published online July 15, 2024; DOI: https://doi.org/10.5217/ir.2024.00005

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.

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The choice of treatment approach for mild and moderate ulcerative colitis: A review
Oleg V. Golovenko, Irina D. Loranskaia, Alexey M. Osadchuk
Consilium Medicum.2025; 27(12): 744. CrossRef

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Filgotinib induction-study baseline characteristics of patients with ulcerative colitis who achieve sustained corticosteroid-free remission: post hoc analysis of the phase 2b/3 SELECTION study: Taku Kobayashi, Axel Dignass, Xavier Roblin, Yoshie Takatori, Toshihiko Kaise, Alessandra Oortwijn, Corinne Jamoul, Toshifumi Hibi; Intest Res 2025;23(1):65-75. Published online June 14, 2024; DOI: https://doi.org/10.5217/ir.2024.00007

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Obtaining and maintaining corticosteroid-free remission are important goals of treatment for ulcerative colitis (UC). Characteristics associated with achieving corticosteroid-free remission were assessed in filgotinib-treated patients in SELECTION, a 58-week, phase 2b/3 trial in moderately to severely active UC.
Methods
This post hoc analysis used data from filgotinib-treated patients receiving corticosteroids at maintenance baseline in SELECTION. Univariate logistic regression was performed to assess induction baseline characteristics associated with 6 months of corticosteroid-free remission at week 58, defined as clinical remission without using corticosteroids for at least 6 months.
Results
At maintenance baseline, 92 and 81 patients were receiving corticosteroids in the filgotinib 200 mg and filgotinib 100 mg groups, respectively. Age, body mass index, history of pancolitis, disease duration, fecal calprotectin levels, C-reactive protein levels, Mayo Clinic Score, concomitant corticosteroids, immunomodulators, and aminosalicylates had no statistically significant effect on the likelihood of achieving corticosteroid-free remission. Baseline characteristics associated with increased odds of corticosteroid-free remission were Mayo Clinic Endoscopic Subscore of 2 (vs. 3) in the filgotinib 200 mg and filgotinib 100 mg groups, and female (vs. male) sex, current (vs. former or never) smoking, and being biologic‑naive (vs. experienced) in the filgotinib 200 mg group.
Conclusions
Steroid tapering can be achieved in patients with UC receiving filgotinib 200 mg independently of baseline characteristics such as clinical activity and duration of illness. However, the likelihood of achieving corticosteroid-free remission was higher among patients who were biologic-naive, current smokers, had low endoscopic inflammatory burden and who were female.

Citations

Citations to this article as recorded by

In which patients with ulcerative colitis would filgotinib be effective?
Jihye Park
Intestinal Research.2025; 23(1): 1. CrossRef
Three Janus kinase inhibitors in ulcerative colitis: is upadacitinib taking the lead?
Yoon Suk Jung
Intestinal Research.2025; 23(4): 394. CrossRef

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Early change in serum leucine-rich α-2-glycoprotein predicts clinical and endoscopic response in ulcerative colitis: Ryo Karashima, Shintaro Sagami, Yoko Yamana, Masa Maeda, Aya Hojo, Yusuke Miyatani, Masaru Nakano, Takahisa Matsuda, Toshifumi Hibi, Taku Kobayashi; Intest Res 2024;22(4):473-483. Published online June 5, 2024; DOI: https://doi.org/10.5217/ir.2023.00135

Abstract PDF PubReader ePub

Background/Aims
Leucine-rich α-2-glycoprotein (LRG) is a new serum biomarker reflecting the disease activity of ulcerative colitis (UC), but its change during the acute phase has not been enough investigated.
Methods
Patients with UC who initiated the induction therapy with steroid or advanced therapy (biologics or Janus kinase inhibitors) were prospectively enrolled. Associations of LRG, C-reactive protein (CRP) and fecal calprotectin (FC) at baseline, week 1, and week 8 with clinical remission at week 8 and subsequent endoscopic improvement within 1 year (Mayo endoscopic subscore of 0 or 1) were assessed.
Results
A total of 143 patients with UC were included. LRG and CRP at week 1 were significantly lower in the clinical remission group than in the non-remission group (LRG, 20.6 μg/mL vs. 28.4 μg/mL, P< 0.001; CRP, 0.9 mg/dL vs. 2.3 mg/dL, P< 0.001) while FC demonstrated the difference between groups only at week 8. The area under the curves of week 1 LRG, CRP, and FC for week 8 clinical remission using the receiver operating characteristic curves analysis were 0.68, 0.71, and 0.57, respectively. Furthermore, LRG and CRP predicted subsequent endoscopic improvement as early as week 1, while FC was predictive only at week 8.
Conclusions
LRG can be an early-phase biomarker predicting subsequent clinical and endoscopic response to induction therapy.

Citations

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Role of leucine-rich α-2-glycoprotein in Taiwanese patients with inflammatory bowel disease as a predictive biomarker for endoscopic activity
Yun-Chu Chen, Meng-Tzu Weng, Feng-Pai Tsai, Zhi-Che Chen, Hsin-Yun Wu, Chien-Chih Tung, Chun-Ying Wang, Shu-Chen Wei
World Journal of Gastroenterology.2026;[Epub] CrossRef
Alpha-2 Glycoprotein in Serum as Noninvasive Biomarker of Inflammatory Bowel Diseases Severity in Children
Andrey N. Surkov, Olga B. Gordeeva, Olga E. Krasnova, Sadig T. Fatullaev, Natalya A. Izotova, Evgeniy E. Bessonov, Irine Dzharkava, Albina V. Dobrotok, Albina D. Guseynova, Mariya S. Rudneva, Elizaveta N. Il’yashenko, Leyla S. Namazova-Baranova
Pediatric pharmacology.2026; 22(6): 672. CrossRef
Leucine-rich alpha-2 glycoprotein as a blood biomarker in inflammatory bowel disease: clinical implications and future perspectives
Takayuki Yamamoto
Expert Review of Gastroenterology & Hepatology.2026; : 1. CrossRef
The diagnostic accuracy of plasma and serum calprotectin is inferior to C-reactive protein in patients with suspected Crohn’s disease
M. H. Rasmussen, J. B. Brodersen, C. L. Brasen, J. S. Madsen, T. Knudsen, J. Kjeldsen, M. D. Jensen
Scandinavian Journal of Gastroenterology.2025; 60(3): 235. CrossRef
Changes of leucine-rich alpha 2 glycoprotein could be a marker of changes of endoscopic and histologic activity of ulcerative colitis
Yuki Aoyama, Sakiko Hiraoka, Eriko Yasutomi, Toshihiro Inokuchi, Takehiro Tanaka, Kensuke Takei, Shoko Igawa, Keiko Takeuchi, Masahiro Takahara, Junki Toyosawa, Yasushi Yamasaki, Hideaki Kinugasa, Jun Kato, Hiroyuki Okada, Motoyuki Otsuka
Scientific Reports.2025;[Epub] CrossRef
Real‐World Effectiveness and Safety of Mirikizumab Induction Therapy in Patients With Ulcerative Colitis: A Multicentre Retrospective Observational Study
Yasuhiro Takagi, Toshiyuki Sato, Takanori Nishiguchi, Akira Nogami, Masataka Igeta, Soichi Yagi, Maiko Ikenouchi, Mikio Kawai, Koji Kamikozuru, Yoko Yokoyama, Toshihiko Tomita, Hirokazu Fukui, Masayuki Fukata, Taku Kobayashi, Shinichiro Shinzaki
Alimentary Pharmacology & Therapeutics.2025; 61(12): 1923. CrossRef
Leucine-Rich Alpha-2 Glycoprotein 1 as a Biomarker for Evaluation of Inflammatory Bowel Disease Activity in Children
Betül Aksoy, Yeliz Çağan Appak, Murat Akşit, Serenay Çetinoğlu, Sinem Kahveci, Şenay Onbaşı Karabağ, Selen Güler, İlksen Demir, İnanç Karakoyun, Maşallah Baran
Journal of Clinical Medicine.2025; 14(8): 2803. CrossRef
Editorial: Real‐World Effectiveness of Mirikizumab in Ulcerative Colitis—A Valuable but Preliminary Glimpse. Authors' Reply
Shinichiro Shinzaki, Yasuhiro Takagi, Toshiyuki Sato
Alimentary Pharmacology & Therapeutics.2025; 61(12): 1967. CrossRef
Real-World Effectiveness of and Optimization Strategies for Mirikizumab in Pediatric Ulcerative Colitis: A Prospective, Observational Study
Keisuke Jimbo, Nobuyasu Arai, Mitsuyoshi Suzuki, Emiko Suzuki, Musashi Hibio, Masumi Nagata, Masamichi Sato, Eri Miyata, Eri Hoshino, Takahiro Kudo, Hiromichi Shoji
Inflammatory Bowel Diseases.2025;[Epub] CrossRef

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Efficacy and safety of mirikizumab as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a subgroup analysis of the global phase 3 LUCENT-1 and LUCENT-2 studies: Taku Kobayashi, Katsuyoshi Matsuoka, Mamoru Watanabe, Tadakazu Hisamatsu, Fumihito Hirai, Joe Milata, Xingyuan Li, Nathan Morris, Vipin Arora, Tomoko Ishizuka, Koji Matsuo, Yoichi Satoi, Catherine Milch, Toshifumi Hibi; Intest Res 2024;22(2):172-185. Published online April 25, 2024; DOI: https://doi.org/10.5217/ir.2023.00043

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Background/Aims
Mirikizumab is a p19-directed anti-interleukin-23 antibody with potential efficacy against ulcerative colitis (UC). We evaluated the efficacy and safety of mirikizumab in a Japanese subpopulation with moderately to severely active UC from the LUCENT-1 and LUCENT-2 studies.
Methods
LUCENT-1 and LUCENT-2 were phase 3, randomized, double-blind, placebo-controlled trials of mirikizumab therapy in adults with moderately to severely active UC. LUCENT-1 was a 12-week induction trial where patients were randomized 3:1 to receive intravenous mirikizumab 300 mg or placebo every 4 weeks (Q4W). Patients achieving a clinical response with mirikizumab following the induction study were re-randomized 2:1 to double-blind treatment with either mirikizumab 200 mg or placebo subcutaneously Q4W during the 40-week maintenance study. The primary outcomes were clinical remission at week 12 of LUCENT-1 and week 40 of LUCENT-2.
Results
A total of 137 patients enrolled in Japan were randomized to mirikizumab (n = 102) or placebo (n = 35). Compared with placebo, patients who received mirikizumab showed numerically higher clinical remission at week 12 of induction (32.4% [n = 33] vs. 2.9% [n = 1]) and at week 40 of maintenance (48.9% [n = 23] vs. 28.0% [n = 7]). A greater number of patients achieved key secondary endpoints in the mirikizumab group compared with placebo. The frequency of treatment-emergent adverse events was similar across mirikizumab and placebo groups. Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.
Conclusions
Mirikizumab induction and maintenance treatments were effective in Japanese patients with moderately to severely active UC. No new safety concerns were identified.

Citations

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Does Mirikizumab benefit patients with plaque psoriasis? a systematic review and meta-analysis
Shrouk F. Mohamed, Mohamed R. Abdelraouf, Mohamed Wagdy, Ahmed Hegazy, Mena Essam, Ahmed Elsekaily
Naunyn-Schmiedeberg's Archives of Pharmacology.2026; 399(1): 521. CrossRef
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Purab Patel, Peter Belesiotis, Nitin Shiv Rai, Yuhong Yuan, Neeraj Narula, Christopher Ma, Maria Cino, Alexa Sasson, Vipul Jairath, Parul Tandon
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Efficacy and safety of IL-23 p19 inhibitors in the treatment for inflammatory bowel disease: a systematic review and meta-analysis
Shuhan Wang, Hui Sun, Qian Wang, Han Xiao
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IBD

Performing colonoscopy before steroid induction is associated with shorter steroid use in patients with ulcerative colitis: Taku Kobayashi, Eri Udagawa, Lisa Hirose, Toshifumi Hibi; Intest Res 2023;21(2):205-215. Published online December 15, 2022; DOI: https://doi.org/10.5217/ir.2021.00164

Abstract PDF PubReader ePub

Background/Aims
Risks of long-term steroid use in patients with ulcerative colitis (UC) outweigh the benefits, thus dosing should be tapered once a response is achieved. Colonoscopy is a key technique for assessing disease severity and optimizing treatment involving steroids. This retrospective longitudinal cohort study of patients with UC explored factors associated with the duration of systemic steroid use.
Methods
The Japan Medical Data Center database, an employer-based insurance claims database, was used to select individuals initiating prednisolone, with a prescription issued between January 1, 2010, and January 31, 2018. The study included adults with a confirmed diagnosis of UC, who had received ≥1 year of continuous treatment with 5-aminosalicylic acid, biologics, or thiopurine. Factors associated with prednisolone duration were assessed using a multivariate regression model.
Results
Median duration of prednisolone treatment was 98 days, and colonoscopy was performed ≤1 month before or at the first prescription of prednisolone (index date) in 32.8% of patients (607/1,853). Shorter durations of prednisolone treatment were associated with colonoscopy ≤1 month before or at the index date and higher prednisolone dose at index date, with incidence rate ratios (IRRs) of 0.776 (95% confidence interval [CI], 0.682–0.884; P<0.001) and 0.998 (95% CI, 0.996–1.000; P=0.018), respectively. Charlson Comorbidity Index scores of 1 and ≥2 predicted longer prednisolone treatment (IRR, 1.332; 95% CI, 1.174–1.511; P<0.001 and IRR, 1.599; 95% CI, 1.357–1.885; P<0.001, respectively).
Conclusions
Performing colonoscopy before or at the time of initiating steroid was associated with a shorter duration of steroid use in patients with UC.

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Quercus infectoria galls mitigates colitis in mice through alleviating mucosal barrier impairment and suppressing inflammatory factors
Yan Ding, Jiao-Jiao Bai, Sabahat Ablimit, Muyassar Yasen, Arfidin Anwar, Kudelaidi Kuerban, Mubarak Iminjan, Guo-Qiang Zhang
Journal of Ethnopharmacology.2025; 343: 119487. CrossRef
Main active components of Sishen Wan may modulate T cells-related proinflammatory cytokines via alleviating mitochondrial damage caused by oxidative stress in dextran sulphate sodium-induced ulcerative colitis
Ke LI, Weiguang LV, Boning ZHANG, Shengnan HAN, Jing HAN, Yu ZHANG, Wei WANG, Weiyu ZANG, Anqi YANG, Hongjia WANG, Chenggang ZHANG
Chinese Journal of Analytical Chemistry.2025; 53(9): 100562. CrossRef

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IBD

Efficacy and safety of filgotinib as induction and maintenance therapy for Japanese patients with moderately to severely active ulcerative colitis: a post-hoc analysis of the phase 2b/3 SELECTION trial: Toshifumi Hibi, Satoshi Motoya, Tadakazu Hisamatsu, Fumihito Hirai, Kenji Watanabe, Katsuyoshi Matsuoka, Masayuki Saruta, Taku Kobayashi, Brian G Feagan, Chantal Tasset, Robin Besuyen, Chohee Yun, Gerald Crans, Jie Zhang, Akira Kondo, Mamoru Watanabe; Intest Res 2023;21(1):110-125. Published online March 11, 2022; DOI: https://doi.org/10.5217/ir.2021.00143

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The safety and efficacy of filgotinib, a once-daily oral Janus kinase 1 preferential inhibitor, were evaluated in Japanese patients with ulcerative colitis (UC) in the phase 2b/3 SELECTION trial.
Methods
SELECTION (NCT02914522) was a randomized, placebo-controlled trial comprising 2 induction studies and a maintenance study. Adults with moderately to severely active UC were randomized in induction study A (biologic-naïve) or B (biologic-experienced) to receive filgotinib 200 mg, 100 mg, or placebo once daily for 11 weeks. Patients in clinical remission or Mayo Clinic score response at week 10 entered the 47-week maintenance study. Efficacy and safety outcomes were assessed in Japanese patients enrolled in Japan.
Results
Overall, 37 and 72 Japanese patients were enrolled in Japan in induction studies A and B, respectively, and 54 entered the maintenance study. Numerically higher proportions of filgotinib 200 mg-treated than placebo-treated patients achieved clinical remission in induction study A (4/15 [26.7%] vs. 0/6 [0%]) and the maintenance study (5/20 [25.0%] vs. 0/9 [0%]), but not induction study B (1/29 [3.4%] vs. 1/14 [7.1%]). Both doses were well tolerated, and no new safety signals were noted. Herpes zoster was reported in 1 filgotinib 200 mg-treated patient in each of induction study A (2.3%, 1/44) and the maintenance study (5.0%, 1/20).
Conclusions
These data, alongside those of the overall SELECTION population, suggest the potential of filgotinib 200 mg as a viable treatment option for Japanese patients with UC. Owing to small patient numbers, data should be interpreted cautiously.

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Quercus infectoria galls mitigates colitis in mice through alleviating mucosal barrier impairment and suppressing inflammatory factors
Yan Ding, Jiao-Jiao Bai, Sabahat Ablimit, Muyassar Yasen, Arfidin Anwar, Kudelaidi Kuerban, Mubarak Iminjan, Guo-Qiang Zhang
Journal of Ethnopharmacology.2025; 343: 119487. CrossRef
Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data
Katsuyoshi Matsuoka, Satoshi Motoya, Takayuki Yamamoto, Minoru Matsuura, Toshimitsu Fujii, Shinichiro Shinzaki, Yohei Mikami, Shoko Arai, Junichi Oshima, Yutaka Endo, Hirotoshi Yuasa, Masato Hoshi, Keiko Sato, Tadakazu Hisamatsu
Journal of Gastroenterology.2025; 60(8): 979. CrossRef
Efficacy and safety of filgotinib for ulcerative colitis: A real‐world multicenter retrospective study in Japan
Shintaro Akiyama, Kaoru Yokoyama, Soichi Yagi, Shinichiro Shinzaki, Kozo Tsuruta, Shinichiro Yoshioka, Minako Sako, Hiromichi Shimizu, Mariko Kobayashi, Toshiyuki Sakurai, Kei Nomura, Tomoyoshi Shibuya, Masahiro Takahara, Sakiko Hiraoka, Kyohei Sugai, Shu
Alimentary Pharmacology & Therapeutics.2024; 59(11): 1413. CrossRef
Real-World Data on the Effectiveness and Safety of Filgotinib for Ulcerative Colitis in Japanese Patients: A Single-Center Experience
Takahito Toba, Ryo Karashima, Kodai Fujii, Keiichi Inoue, Nanako Inoue, Yurie Ogawa, Aya Hojo, Ai Fujimoto, Takahisa Matsuda
Cureus.2024;[Epub] CrossRef
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Hyuk Yoon, Byong Duk Ye, Sang-Bum Kang, Kang-Moon Lee, Chang Hwan Choi, Joo-young Jo, Juwon Woo, Jae Hee Cheon
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Jun Lee
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Olga Maria Nardone, Irene Zammarchi, Giovanni Santacroce, Subrata Ghosh, Marietta Iacucci
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Stefan Schreiber, Gerhard Rogler, Mamoru Watanabe, Séverine Vermeire, Christian Maaser, Silvio Danese, Margaux Faes, Paul Van Hoek, Jeremy Hsieh, Ulrik Moerch, Yan Zhou, Angela de Haas, Christine Rudolph, Alessandra Oortwijn, Edward V. Loftus
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Filgotinib for moderately to severely active ulcerative colitis
Alessandro Mannucci, Ferdinando D’Amico, Ahmad El Saadi, Laurent Peyrin-Biroulet, Silvio Danese
Expert Review of Gastroenterology & Hepatology.2022; 16(10): 927. CrossRef

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Inflammatory Bowel Diseases

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study: Tadakazu Hisamatsu, Yasuo Suzuki, Mariko Kobayashi, Takashi Hagiwara, Takeshi Kawaberi, Haruhiko Ogata, Toshiyuki Matsui, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):408-418. Published online November 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00025

Abstract PDF PubReader ePub

Background/Aims
Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings.
Methods
This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI).
Results
The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks.
Conclusions
Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

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Daniele Balducci, Marta Mosca, Sabrina Monaco, Susanna Faenza, Stefano Fabiani, Fabio Cortellini, Nicola Cesaro, Gianpiero Stefanelli, Salvatore Paba, Maddalena Pecchini, Michele Montori, Marco Valvano
Gastrointestinal Disorders.2026; 8(1): 13. CrossRef
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Stephen B. Hanauer, Byong Duk Ye, Raymond K. Cross, Silvio Danese, Geert D’Haens, Jinah Jung
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Effect of Perianal Fistula on the Quality of Life and Work Productivity of Patients with Crohn's Disease: Report of a Questionnaire Survey
Naoto Saigusa, Takeshi Inaba
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Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
The Korean Journal of Internal Medicine.2023; 38(5): 661. CrossRef
Clinical features of enteric and colo-duodenal fistula in patients with Crohn’s disease
Jun Su Lee, Sang-Bum Kang, Kwangbeom Park, Yong Sik Yoon, Chang Sik Yu, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Jong Lyul Lee, Sang Hyoung Park
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Julie J. Hong, Edward K. Hadeler, Megan L. Mosca, Nicholas D. Brownstone, Tina Bhutani, Wilson J. Liao
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Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
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Adam Saleh, Usman Ansari, Shaadi Abughazaleh, Kerri Glassner, Bincy P Abraham
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Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
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Juntao Yin, Yang Li, Yangyang Chen, Chaoyang Wang, Xiaoyong Song
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Eun Mi Song, Suk-Kyun Yang
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Jihye Park, Jae Hee Cheon
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Ji Young Chang, Jae Hee Cheon
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Inflammatory Bowel Diseases

Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study: Haruhiko Ogata, Takashi Hagiwara, Takeshi Kawaberi, Mariko Kobayashi, Toshifumi Hibi; Intest Res 2021;19(4):419-429. Published online November 10, 2020; DOI: https://doi.org/10.5217/ir.2020.00033

Abstract PDF PubReader ePub

Background/Aims
Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.
Methods
In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.
Results
Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.
Conclusions
This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.

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The Evolving Landscape of Advanced Therapies in Inflammatory Bowel Disease: Current Evidence and Emerging Targets
Daniele Balducci, Marta Mosca, Sabrina Monaco, Susanna Faenza, Stefano Fabiani, Fabio Cortellini, Nicola Cesaro, Gianpiero Stefanelli, Salvatore Paba, Maddalena Pecchini, Michele Montori, Marco Valvano
Gastrointestinal Disorders.2026; 8(1): 13. CrossRef
Effect of Biologic Therapies in Treating Moderate-to-Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis
Ooha Thadiboina, Syed Saim Ali Shah, Rubela Ray, Sarah A Hack, Mahpara Munir, Qalandar Shah, Amritveer Bhullar, Syed Zargham Hussain Shah, Mohammed Abdul Muhaimin Ali, Uzma Nureen , Sana Afzal, Izzat Izzat
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Ieshaan S. Kumar, Rahul S. Dalal
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Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
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Real‐world experience of adalimumab therapy for patients with ulcerative colitis: A single tertiary medical center experience in Central Taiwan
Hsu‐Heng Yen, Yu‐Chun Hsu, Chu‐Hsuan Kuo, Tsui‐Chun Hsu, Yang‐Yuan Chen
Advances in Digestive Medicine.2023; 10(1): 28. CrossRef
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Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Safety of Adalimumab: An Analysis of the FDA Adverse Event Reporting System (FAERS) Database
Buthainah Ghanem
Jordan Journal of Pharmaceutical Sciences.2023; 16(3): 517. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran
Pezhman Alavinejad, Sana Delavari, Abazar Parsi, Ali Akbar Shayesteh
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Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study
Seung Yong Shin, Soo Jung Park, Young Kim, Jong Pil Im, Hyo Jong Kim, Kang-Moon Lee, Ji Won Kim, Sung-Ae Jung, Jun Lee, Sang-Bum Kang, Sung Jae Shin, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Kim, Dong Il Park, Hyung Kil Kim, Eun Soo Kim, Young-Ho Ki
Intestinal Research.2022; 20(3): 350. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Do We Have an Opportunity to Avoid Opportunistic Infections in Asian Patients with Inflammatory Bowel Disease?
Suhyun Park, Sang Hyoung Park
Gut and Liver.2022; 16(5): 663. CrossRef
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Byung Chul Jin, Hee Jin Moon, Sang Wook Kim
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Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
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Katarzyna Komosinska-Vassev, Aleksandra Kałużna, Agnieszka Jura-Półtorak, Alicja Derkacz, Krystyna Olczyk
Journal of Clinical Medicine.2022; 11(19): 5618. CrossRef
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Jihye Park, Jae Hee Cheon
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Inflammatory Bowel Diseases

Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study: Yasuo Suzuki, Takashi Hagiwara, Mariko Kobayashi, Kazuo Morita, Tomoyo Shimamoto, Toshifumi Hibi; Intest Res 2021;19(3):301-312. Published online August 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00013

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease.
Methods
This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels.
Results
Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37).
Conclusions
This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

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Inflammatory Bowel Diseases

Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis: Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):448-460. Published online August 18, 2020; DOI: https://doi.org/10.5217/ir.2020.00026

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Background/Aims
A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods
Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results
Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions
Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)

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Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
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Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
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Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis
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Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis
Xinqiao Chu, Yaning Biao, Chengjiang Liu, Yixin Zhang, Chenxu Liu, Ji-zheng Ma, Yufeng Guo, Yaru Gu
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Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch
Digestive and Liver Disease.2022; 54(9): 1168. CrossRef
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Sheridan M. Hoy
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Katsuyoshi Matsuoka, Mamoru Watanabe, Toshihide Ohmori, Kouichi Nakajima, Tetsuya Ishida, Yoh Ishiguro, Kazunari Kanke, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Hidehiro Mizusawa, Shuji Kishida, Yoshiharu Miura, Akira Ohta, Toshifumi Kajioka, T
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Corrigendum

Corrigendum: Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients: Keiji Yagisawa, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Takahiko Toyonaga, Miki Miura, Mari Hayashida, Eiko Saito, Masaru Nakano, Hajime Matsubara, Tadakazu Hisamatsu, Toshifumi Hibi; Intest Res 2020;18(3):343-344. Published online July 20, 2020; DOI: https://doi.org/10.5217/ir.2018.00078-c1; Corrects: Intest Res 2019;17(1):87

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Original Articles

Inflammatory Bowel Diseases

Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn’s disease: Hiroyuki Okamoto, Nathanael L. Dirks, Maria Rosario, Tetsuharu Hori, Toshifumi Hibi; Intest Res 2021;19(1):95-105. Published online July 10, 2020; DOI: https://doi.org/10.5217/ir.2019.09167

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Vedolizumab is indicated for moderately-to-severely active ulcerative colitis (UC) and Crohn’s disease (CD). Because multiple factors may result in different pharmacokinetics and clinical efficacies, understanding determinants of vedolizumab clearance may enhance dose and treatment strategies. The aim was to characterize vedolizumab pharmacokinetics in Asian and non-Asian UC and CD patients.
Methods
Population pharmacokinetic analysis for repeated measures, using data from 5 studies, was conducted using nonlinear mixed-effects modeling. A Bayesian estimation approach in NONMEM 7.3 was utilized to leverage the predominantly sparse data available for this analysis with results from a prior population pharmacokinetic analysis of vedolizumab.
Results
Vedolizumab pharmacokinetics were described by a 2-compartment model with parallel linear and nonlinear elimination. Using reference covariate values, linear elimination half life of vedolizumab was 24.7 days for anti-vedolizumab antibody (AVA)-negative patients and 18.1 days for AVA-positive patients; linear clearance (CL_L) was 0.165 L/day for AVA-negative patients and 0.246 L/day for AVA-positive patients; central (V_c) and peripheral compartment volumes of distribution were 3.16 L and 1.84 L, respectively. Interindividual variabilities (percent coefficient of variation) were 30.8% for CL_L and 19% for V_c; interoccasion variability on CL_L was 20.3%; residual variance was 17.8%. For albumin, body weight and AVA, only extreme values were identified as potentially clinically important predictors of CL_L. The effect of race (Asian/non-Asian) and diagnosis (UC/CD) on CL_L was negligible and likely not of clinical importance.
Conclusions
Pharmacokinetic parameters were similar in Asian and non-Asian patients with moderately-to-severely active UC and CD. This analysis supports use of vedolizumab flat-fixed dosing in these patients. (Clinicaltrials.gov Identifiers: NCT00783718 (GEMINI 1); NCT00783692 (GEMINI 2). CCT 101; NCT02039505 and CCT-001; NCT02038920)

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Association of early vedolizumab trough levels with clinical, biochemical, endoscopic response and drug optimization during maintenance therapy in patients with inflammatory bowel diseases
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Inflammatory Bowel Diseases

Efficacy of biologic therapies for biologic-naïve Japanese patients with moderately to severely active ulcerative colitis: a network meta-analysis: Toshifumi Hibi, Isao Kamae, Philippe Pinton, Lyann Ursos, Ryuichi Iwakiri, Greg Hather, Haridarshan Patel; Intest Res 2021;19(1):53-61. Published online April 22, 2020; DOI: https://doi.org/10.5217/ir.2019.09146

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Several biologic therapies are approved in Japan to treat moderately to severely active ulcerative colitis (UC), but there are no published comparative efficacy studies in a Japanese population. We compared the efficacy of biologics approved in Japan (adalimumab, infliximab, golimumab, and vedolizumab) for treating biologic-naïve patients with UC at their approved doses.
Methods
A targeted literature review identified 4 randomized controlled trials of biologics for UC in biologicnaïve Japanese patients. For each study, efficacy outcome data from induction (weeks 6–12) and maintenance (weeks 30–60) treatment were extracted for analysis. Treatment effects on clinical response, clinical remission, and mucosal healing relative to the average placebo results across all trials were estimated using network meta-analyses followed by transformation into probabilities and odds ratios (OR).
Results
At the end of induction, the likelihood of clinical response and clinical remission was highest with infliximab (OR: 2.12 and 2.35, respectively) and vedolizumab (OR: 2.10 and 2.32, respectively); the likelihood of mucosal healing was highest with infliximab (OR: 2.24) and adalimumab (OR: 1.86). During maintenance, the likelihood of clinical response and clinical remission was highest with vedolizumab (OR: 6.44 and 4.68, respectively) and golimumab (OR: 5.13 and 3.84, respectively); the likelihood of mucosal healing was significantly higher than placebo with all biologics.
Conclusions
All active treatments were efficacious compared with placebo. Infliximab and vedolizumab had the highest odds for induction of clinical response, remission, and mucosal healing. Golimumab and vedolizumab had numerically higher odds of achieving efficacy outcomes in the maintenance phase.

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Eun Ae Kang
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Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
Kyuwon Kim, Hee Seung Hong, Kyunghwan Oh, Jae Yong Lee, Seung Wook Hong, Jin Hwa Park, Sung Wook Hwang, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Byong Duk Ye, Sang Hyoung Park
The Korean Journal of Internal Medicine.2022; 37(6): 1140. CrossRef
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
Gut and Liver.2022; 16(5): 764. CrossRef
Latent and Active Tuberculosis Infection in Patients with Inflammatory Bowel Disease
Byung Chul Jin, Hee Jin Moon, Sang Wook Kim
The Korean Journal of Gastroenterology.2022; 80(2): 72. CrossRef
Improvement in Medication Adherence after Pharmacist Intervention Is Associated with Favorable Clinical Outcomes in Patients with Ulcerative Colitis
Jae Song Kim, Min Jung Geum, Eun Sun Son, Yun Mi Yu, Jae Hee Cheon, Kyeng Hee Kwon
Gut and Liver.2022; 16(5): 736. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef
Risk and characteristics of tuberculosis after anti-tumor necrosis factor therapy for inflammatory bowel disease: a hospital-based cohort study from Korea
Jae Yong Lee, Kyunghwan Oh, Hee Seung Hong, Kyuwon Kim, Seung Wook Hong, Jin Hwa Park, Sung Wook Hwang, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Ho-Su Lee, Kyung-Wook Jo, Sang Hyoung Park
BMC Gastroenterology.2021;[Epub] CrossRef

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Inflammatory bowel diseases

Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study: Masayuki Saruta, Dong Il Park, Young-Ho Kim, Suk-Kyun Yang, Byung-Ik Jang, Jae Hee Cheon, Jong Pil Im, Takanori Kanai, Tatsuro Katsuno, Yoh Ishiguro, Makoto Nagaoka, Naoki Isogawa, Yinhua Li, Anindita Banerjee, Alaa Ahmad, Mina Hassan-Zahraee, Robert Clare, Kenneth J. Gorelick, Fabio Cataldi, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2020;18(1):45-55. Published online January 30, 2020; DOI: https://doi.org/10.5217/ir.2019.00039

Abstract PDF PubReader ePub

Background/Aims
PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD).
Methods
OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients.
Results
In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment.
Conclusions
In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509)

Citations

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Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease
Hiroshi Nakase
Internal Medicine.2026; 65(2): 214. CrossRef
Soluble mucosal addressin cell adhesion molecule 1 is a biomarker for pediatric ulcerative colitis
Moritz Muschaweck, Christian Gutbier, Gernot Sellge, Angeliki Pappa, Tobias Wenzl, Karim Hamesch, Norbert Wagner, Angela Schippers
Molecular and Cellular Pediatrics.2026;[Epub] CrossRef
Novel Histone Deacetylase 6 Inhibitor Confers Anti-inflammatory Effects and Enhances Gut Barrier Function
Jae-Young Lee, Hyun Woo Ma, Ji Hyung Kim, I Seul Park, Mijeong Son, Keun Ho Ryu, Jieun Shin, Seung Won Kim, Jae Hee Cheon
Gut and Liver.2023; 17(5): 766. CrossRef
Downregulation of Heat Shock Protein 72 Contributes to Fibrostenosis in Crohn’s Disease
Seung Won Kim, Jae-Young Lee, Han Cheol Lee, Jae Bum Ahn, Ji Hyung Kim, I Seul Park, Jae Hee Cheon, Duk Hwan Kim
Gut and Liver.2023; 17(6): 905. CrossRef
Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef
Renin–angiotensin system in intestinal inflammation—Angiotensin inhibitors to treat inflammatory bowel diseases?
Hanne Salmenkari, Riitta Korpela, Heikki Vapaatalo
Basic & Clinical Pharmacology & Toxicology.2021; 129(3): 161. CrossRef
Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents
Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
Expert Opinion on Investigational Drugs.2021; 30(10): 1037. CrossRef
Emerging therapeutic options in inflammatory bowel disease
Jesus K Yamamoto-Furusho, Norma N Parra-Holguín
World Journal of Gastroenterology.2021; 27(48): 8242. CrossRef

18,724 View
201 Download
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Inflammatory bowel diseases

Predictive factors for achievement of mucosal healing by budesonide 2-mg foam in ulcerative colitis: a pooled analysis of data from two clinical trials: Toshifumi Hibi, Makoto Naganuma, Eisei Oda, Yoji Yamada, Yoshitomo Chujoh, Ryoichi Yoshihara, Mamoru Watanabe; Intest Res 2020;18(1):56-68. Published online December 11, 2019; DOI: https://doi.org/10.5217/ir.2019.00064

Abstract PDF PubReader ePub

Background/Aims
Mucosal healing (MH) of distal lesions in ulcerative colitis (UC) has recently been confirmed with budesonide 2-mg foam (BF) treatment in 2 clinical trials; however, few studies have investigated the predictive factors for complete MH.
Methods
We conducted a post hoc analysis using pooled data from phase II and III clinical trials evaluating the efficacy and safety of BF for UC. Additionally, we analyzed the relationships between complete MH and baseline factors and clinical symptoms from baseline to week 6.
Results
Among the 291 Japanese patients from the 2 pooled clinical studies, 119 patients in the BF twice a day group and 117 in the placebo group were included in the full analysis set. The proportion of patients with a rectal bleeding (RB) subscore of 0 was significantly higher in the BF group than in the placebo group after a 5-day treatment (P<0.05). After a 2-day treatment, significantly more patients in the BF group had a stool frequency (SF) subscore of 0 than patients in the placebo group (P<0.05). Multivariate analysis showed that complete MH at week 6 was influenced by baseline SF subscore and 5-aminosalicylic acid (5-ASA) enema or suppository use (P=0.0086 and P=0.0015, respectively). The relationship between complete MH at week 6 and RB subscore after week 2 was also confirmed.
Conclusions
Normal SF at baseline, history of 5-ASA topical product use, and elimination of RB after week 2 are suggested predictors of complete MH at week 6 with twice-daily BF treatment.

Citations

Citations to this article as recorded by

Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku Kobayashi, Kei Moriya, Toshimitsu Fujii, Shigeki Bamba, Shinichiro Shinzaki, Akihiro Yamada, Takashi Hisabe, Shintaro Sagami, Shuji Hibiya, Takahiro Amano, Noritaka Takatsu, Katsutoshi Inagaki, Ken-ichi Iwayama, Toshifumi Hibi
Intestinal Research.2025; 23(2): 157. CrossRef
Impact of twice‐daily budesonide foam administration on early clinical response and endoscopic remission in patients with ulcerative colitis: a post hoc analysis
Kenji Watanabe, Fumihito Hirai, Kiyonori Kobayashi, Ken Takeuchi, Shinsuke Kurosu, Katsutoshi Inagaki, Ken‐ichi Iwayama, Makoto Naganuma
Journal of Gastroenterology and Hepatology.2024; 39(11): 2367. CrossRef
Precision medicine and drug optimization in adult inflammatory bowel disease patients
Sophie Vieujean, Edouard Louis
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef
The Prognostic Value of Residual Nonrectal Inflammation in Ulcerative Colitis
Eun Ae Kang
Gut and Liver.2022; 16(3): 487. CrossRef
Bowel frequency (night) and urgent defecation are improved by budesonide foam in patients with ulcerative colitis: a retrospective observational study
Ryosuke Miyazaki, Toshiyuki Sakurai, Mariko Shimada, Yuko Iwashita, Naoki Shibuya, Yoshihiro Akita, Haruna Miyashita, Yuki Maruyama, Masayuki Saruta
BMC Gastroenterology.2022;[Epub] CrossRef
Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Budesonide MMX in the Treatment of Ulcerative Colitis: Current Perspectives on Efficacy and Safety
Giovanni Maconi, Deborah Camatta, Rosanna Cannatelli, Francesca Ferretti, Anna Carvalhas Gabrielli, Sandro Ardizzone
Therapeutics and Clinical Risk Management.2021; Volume 17: 285. CrossRef

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Inflammatory bowel diseases

Infliximab biosimilar CT-P13 is interchangeable with its originator for patients with inflammatory bowel disease in real world practice: Tomoo Nakagawa, Taku Kobayashi, Kiyohiro Nishikawa, Fumika Yamada, Satoshi Asai, Yukinori Sameshima, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2019;17(4):504-515. Published online August 23, 2019; DOI: https://doi.org/10.5217/ir.2019.00030

Abstract PDF PubReader ePub

Background/Aims
An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease.
Methods
Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018.
Results
Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group.
Conclusions
In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.

Citations

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Efficacy and safety of biosimilar infliximab in bio-naïve patients with Crohn’s disease
Tsubasa Oike, Naoki Akizue, Yuki Ohta, Hirotaka Koseki, Masaya Saito, Yuya Yokoyama, Yushi Imai, Takashi Taida, Kenichiro Okimoto, Keiko Saito, Sadahisa Ogasawara, Tomoaki Matsumura, Tomoo Nakagawa, Makoto Arai, Tatsuro Katsuno, Yoshihiro Fukuda, Yoshio K
Arab Journal of Gastroenterology.2024; 25(3): 257. CrossRef
Systematic review: effectiveness and safety of switching between originator infliximab and biosimilar infliximab in patients with inflammatory bowel disease
Gary R. Lichtenstein, Arif Soonasra, Mark Latymer, Sheena Singh, Brian G. Feagan
Expert Opinion on Biological Therapy.2024; 24(7): 691. CrossRef
Clinical experience of using biosimilars in Crohn’s disease and their effectiveness
Léa Sequier, Bénédicte Caron, Silvio Danese, Laurent Peyrin-Biroulet
Expert Opinion on Biological Therapy.2024; 24(10): 1145. CrossRef
Comparison of the Pharmacokinetics of CT-P13 Between Crohn’s Disease and Ulcerative Colitis
Eun Soo Kim, Sung Kook Kim, Dong Il Park, Hyo Jong Kim, Yoo Jin Lee, Ja Seol Koo, Eun Sun Kim, Hyuk Yoon, Ji Hyun Lee, Ji Won Kim, Sung Jae Shin, Hyung Wook Kim, Hyun-Soo Kim, Young Sook Park, You Sun Kim, Tae Oh Kim, Jun Lee, Chang Hwan Choi, Dong Soo Ha
Journal of Clinical Gastroenterology.2023; 57(6): 601. CrossRef
Long-term effectiveness and safety of infliximab-biosimilar: A multicenter Phoenix retrospective cohort study
Tomoe Kazama, Katsuyoshi Ando, Nobuhiro Ueno, Mikihiro Fujiya, Takahiro Ito, Atsuo Maemoto, Keisuke Ishigami, Masanori Nojima, Hiroshi Nakase, Shintaro Sagami
PLOS ONE.2023; 18(9): e0288393. CrossRef
Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Akimichi Morita, Mamitaro Ohtsuki, Yasuo Suzuki, Mamoru Watanabe, Hisashi Yamanaka, Toshifumi Hibi
Drug Safety.2023; 46(10): 991. CrossRef
Real-world safety and efficacy of CT-P13, an infliximab biosimilar, in Japanese rheumatoid arthritis patients naïve to or switched from biologics
Tsutomu Takeuchi, Kiyohiro Nishikawa, Fumika Yamada, Shiro Ohshima, Makoto Inoue, Yutaka Yoshioka, Hisashi Yamanaka
Modern Rheumatology.2022; 32(4): 718. CrossRef
Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study)
Bincy Abraham, Bertus Eksteen, Khan Nedd, Hrishikesh Kale, Dipen Patel, Jennifer Stephens, Ahmed Shelbaya, Richard Chambers, Arif Soonasra
Advances in Therapy.2022; 39(5): 2109. CrossRef
Safety, efficacy, and drug survival of the infliximab biosimilar CT‐P13 in post‐marketing surveillance of Japanese patients with psoriasis
Akimichi Morita, Kiyohiro Nishikawa, Fumika Yamada, Keiichi Yamanaka, Hideki Nakajima, Mamitaro Ohtsuki
The Journal of Dermatology.2022; 49(10): 957. CrossRef
Post‐marketing analysis for biosimilar CT‐P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan
Shintaro Sagami, Kiyohiro Nishikawa, Fumika Yamada, Yasuo Suzuki, Mamoru Watanabe, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2021; 36(8): 2091. CrossRef
Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future
Brian Godman, Mainul Haque, Santosh Kumar, Salequl Islam, Jaykaran Charan, Farhana Akter, Amanj Kurdi, Eleonora Allocati, Muhammed Abu Bakar, Sagir Abdur Rahim, Nusrat Sultana, Farzana Deeba, M. A. Halim Khan, A. B. M Muksudul Alam, Iffat Jahan, Zubair Ma
Current Medical Research and Opinion.2021; 37(9): 1529. CrossRef
Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness
Jae Hee Cheon, Seongsu Nah, Hyoun Woo Kang, Yun Jeong Lim, Sang-Hoon Lee, Sang Joon Lee, Sung Hyun Kim, Na Hyun Jung, Jeong Eun Park, Yeo Jin Lee, Da Bee Jeon, Yeon Mi Lee, Jong Min Kim, Sung-Hwan Park
Advances in Therapy.2021; 38(8): 4366. CrossRef
The Great Debate With IBD Biosimilars
Jimmy K Limdi, Francis A Farraye
Crohn's & Colitis 360.2021;[Epub] CrossRef
Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef
Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study
Stephanie L. Ho, Fang Niu, Suresh Pola, Fernando S. Velayos, Xian Ning, Rita L. Hui
BioDrugs.2020; 34(3): 395. CrossRef
Post-Marketing Pooled Safety Analysis for CT-P13 Treatment of Patients with Immune-Mediated Inflammatory Diseases in Observational Cohort Studies
Sang Joon Lee, KyungMin Baek, Sujin Lee, Yoon Jee Lee, Jeong Eun Park, Seul Gi Lee
BioDrugs.2020; 34(4): 513. CrossRef
Hepatotoxicty of Agents Used in the Management of Inflammatory Bowel Disease: a 2020 Update
Michele S. Barnhill, Joshua M. Steinberg, Joseph J. Jennings, James H. Lewis
Current Gastroenterology Reports.2020;[Epub] CrossRef

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Inflammatory bowel diseases

Efficacy and safety of abrilumab, an α4β7 integrin inhibitor, in Japanese patients with moderate-to-severe ulcerative colitis: a phase II study: Toshifumi Hibi, Satoshi Motoya, Toshifumi Ashida, Souken Sai, Yukinori Sameshima, Shiro Nakamura, Atsuo Maemoto, Masahiro Nii, Barbara A Sullivan, Robert A. Gasser Jr, Yasuo Suzuki; Intest Res 2019;17(3):375-386. Published online February 12, 2019; DOI: https://doi.org/10.5217/ir.2018.00141

Abstract PDF PubReader ePub

Background/Aims
Inhibition of α4β7 integrin has been shown to be effective for induction and maintenance therapy in patients with ulcerative colitis (UC). We investigated the effects of varying doses of the α4β7 inhibitor abrilumab in Japanese patients with moderate-to-severe UC despite conventional treatments.
Methods
In this randomized, double-blind, placebocontrolled study, 45 UC patients were randomized to abrilumab 21 mg (n=11), 70 mg (n=12), 210 mg (n=9), or placebo (n=13) via subcutaneous (SC) injection for 12 weeks. The double-blind period was followed by a 36-week open-label period, in which all patients received abrilumab 210 mg SC every 12 weeks, and a 28-week safety follow-up period. The primary efficacy variable was clinical remission at week 8 (total Mayo score ≤2 points with no individual subscore >1 point).
Results
Clinical remission at week 8 was 4 out of 31 (12.9%) overall in the abrilumab groups versus 0 out of 13 in the placebo group (abrilumab 21 mg, 1/10 [10.0%]; 70 mg, 2/12 [16.7%]; 210 mg, 1/9 [11.1%]). In both the double-blind and open-label periods, fewer patients in the abrilumab groups experienced ≥1 adverse event compared with those in the placebo group. There were no cases of progressive multifocal leukoencephalopathy and no deaths.
Conclusions
Abrilumab 70 mg and 210 mg yielded numerically better results in terms of clinical remission rate at Week 8 than placebo, with the 210 mg dose showing more consistent treatment effects. Abrilumab was well tolerated in Japanese patients with UC.

Citations

Citations to this article as recorded by

Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease
Hiroshi Nakase
Internal Medicine.2026; 65(2): 214. CrossRef
Advancing therapeutic frontiers: a pipeline of novel drugs for UC management
Luisa Bertin, Alessandro Massano, Carlo Redavid, Marco Scarpa, Cesare Ruffolo, Imerio Angriman, Andrea Buda, Fabiana Zingone, Brigida Barberio, Edoardo Vincenzo Savarino
Frontiers in Gastroenterology.2026;[Epub] CrossRef
Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies
Antonio M. Caballero Mateos, Guillermo A. Cañadas de la Fuente, Beatriz Gros
Journal of Clinical Medicine.2025; 14(5): 1536. CrossRef
Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems
Ahmed Aljabri, Ghareb M. Soliman, Yasmin N. Ramadan, Mohammed A. Medhat, Helal F. Hetta
Clinical and Experimental Medicine.2025;[Epub] CrossRef
Vedolizumab: Beyond Inflammatory Bowel Disease
Yafang Li, Minli Hu, Yuan Chen, Xiao-Yun Yang, Qunying Wang, Jin Ding, Yibing Hu
Medical Principles and Practice.2025; 34(5): 405. CrossRef
Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis
Lorenzo Vittorio Rindi, Drieda Zaçe, Neva Braccialarghe, Barbara Massa, Virginia Barchi, Roberta Iannazzo, Ilenia Fato, Francesco De Maria, Dimitra Kontogiannis, Vincenzo Malagnino, Loredana Sarmati, Marco Iannetta
Drug Safety.2024; 47(4): 333. CrossRef
Targeting integrin pathways: mechanisms and advances in therapy
Xiaocong Pang, Xu He, Zhiwei Qiu, Hanxu Zhang, Ran Xie, Zhiyan Liu, Yanlun Gu, Nan Zhao, Qian Xiang, Yimin Cui
Signal Transduction and Targeted Therapy.2023;[Epub] CrossRef
Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials
Laura Neurath, Ferdinando D’Amico, Silvio Danese
Expert Opinion on Emerging Drugs.2023; 28(1): 27. CrossRef
Inflammatory Bowel Disease: Emerging Therapies and Future Treatment Strategies
Elisabetta Bretto, Davide Giuseppe Ribaldone, Gian Paolo Caviglia, Giorgio Maria Saracco, Elisabetta Bugianesi, Simone Frara
Biomedicines.2023; 11(8): 2249. CrossRef
Integrin signaling in cancer: bidirectional mechanisms and therapeutic opportunities
Siyi Li, Chibuzo Sampson, Changhao Liu, Hai-long Piao, Hong-Xu Liu
Cell Communication and Signaling.2023;[Epub] CrossRef
Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics
Quan Lu, Mei-feng Yang, Yu-jie Liang, Jing Xu, Hao-ming Xu, Yu-qiang Nie, Li-sheng Wang, Jun Yao, De-feng Li
Journal of Inflammation Research.2022; Volume 15: 1825. CrossRef
Factors predicting clinical and endoscopic remission with placebo therapy in East Asian patients with ulcerative colitis: a systematic review and meta-analysis
Jian Zeng, Zhong Wang, Xiao-Jun Yang
European Journal of Clinical Pharmacology.2022; 78(7): 1069. CrossRef
Tackling Inflammatory Bowel Diseases: Targeting Proinflammatory Cytokines and Lymphocyte Homing
Yijie Song, Man Yuan, Yu Xu, Hongxi Xu
Pharmaceuticals.2022; 15(9): 1080. CrossRef
Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef
Anti-Integrins for the Treatment of Inflammatory Bowel Disease: Current Evidence and Perspectives
John Gubatan, Kian Keyashian, Samuel JS Rubin, Jenny Wang, Cyrus Buckman, Sidhartha Sinha
Clinical and Experimental Gastroenterology.2021; Volume 14: 333. CrossRef
Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents
Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
Expert Opinion on Investigational Drugs.2021; 30(10): 1037. CrossRef
Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
Intestinal Research.2021; 19(4): 448. CrossRef
Emerging therapeutic options in inflammatory bowel disease
Jesus K Yamamoto-Furusho, Norma N Parra-Holguín
World Journal of Gastroenterology.2021; 27(48): 8242. CrossRef
Subcutaneous integrin inhibitors may provide more treatment options for patients with moderate-to-severe ulcerative colitis
Hyuk Yoon
Intestinal Research.2019; 17(3): 283. CrossRef

10,504 View
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20 Web of Science
19 Crossref

IBD

Individualized treatment based on CYP3A5 single-nucleotide polymorphisms with tacrolimus in ulcerative colitis: Shinji Okabayashi, Taku Kobayashi, Eiko Saito, Takahiko Toyonaga, Ryo Ozaki, Shintaro Sagami, Masaru Nakano, Junichi Tanaka, Keiji Yagisawa, Satoshi Kuronuma, Osamu Takeuchi, Toshifumi Hibi; Intest Res 2019;17(2):218-226. Published online February 7, 2019; DOI: https://doi.org/10.5217/ir.2018.00117

Abstract PDF PubReader ePub

Background/Aims
The pharmacokinetics of tacrolimus (TAC) is known to be largely influenced by single-nucleotide polymorphisms (SNPs) in CYP3A5. Patients starting TAC require careful dose adjustment, owing to the wide range of optimal dosages, depending on their CYP3A5 expression status. Here, we evaluated whether individualization of TAC dosages based on CYP3A5 SNPs would improve its therapeutic efficacy in ulcerative colitis.
Methods
Twenty-one patients were prospectively treated, with their initial dosage adjusted according to their CYP3A5 status (0.1, 0.15, and 0.2 mg/kg/day for CYP3A5*3/*3, CYP3A5*1/*3, and CYP3A5*1/*1, respectively). Their clinical outcomes were compared with those of patients treated with a fixed dose (0.1 mg/kg/day).
Results
The first blood trough level of CYP3A5 expressors, CYP3A5*1/*3 or CYP3A5*1/*1, and the overall rate in achieving the target blood trough level within a week in the individualized-dose group were significantly higher than those in the fixed-dose group (5.15±2.33 ng/mL vs. 9.63±0.79 ng/mL, P=0.035 and 12.5% vs. 66.7%, P=0.01). The remission rate at 2 weeks in the expressors was as high as that in the nonexpressors, CYP3A5*3/*3, in the individualized-dose group.
Conclusions
Individualized TAC treatment is effective against ulcerative colitis regardless of the CYP3A5 genotype.

Citations

Citations to this article as recorded by

The impact of cytochrome P450 3A genetic polymorphisms on tacrolimus pharmacokinetics in ulcerative colitis patients
Maizumi Furuse, Shuhei Hosomi, Yu Nishida, Shigehiro Itani, Yuji Nadatani, Shusei Fukunaga, Koji Otani, Fumio Tanaka, Yasuaki Nagami, Koichi Taira, Noriko Kamata, Toshio Watanabe, Kenji Watanabe, Yasuhiro Fujiwara, Erika Cecchin
PLOS ONE.2021; 16(4): e0250597. CrossRef
Advances in research of tacrolimus for treatment of inflammatory bowel disease
Jing-Jing Wang, Yi-Hong Fan
World Chinese Journal of Digestology.2019; 27(13): 842. CrossRef

9,376 View
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2 Crossref

IBD

Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients: Keiji Yagisawa, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Takahiko Toyonaga, Miki Miura, Mari Hayashida, Eiko Saito, Masaru Nakano, Hajime Matsubara, Tadakazu Hisamatsu, Toshifumi Hibi; Intest Res 2019;17(1):87-93. Published online December 14, 2018; DOI: https://doi.org/10.5217/ir.2018.00078; Correction in: Intest Res 2020;18(3):343

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Background/Aims
Oral mesalazine is an important treatment for ulcerative colitis (UC), and non-adherence to mesalazine increases the risk of relapse. Controlled-release (CR) mesalazine has 2 formulations: tablets and granules. The relative acceptabilities of these formulations may influence patient adherence; however, they have not been compared to date. This study aimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossover questionnaire survey.
Methods
UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group took either 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6 to 9 weeks. The acceptability and efficacy were evaluated by questionnaires, and adherence was assessed using a visual analog scale. The difference in acceptabilities between the 2 formulations and its impact on adherence were assessed.
Results
A total of 49 patients were prospectively enrolled and 33 patients were included in the analysis. Significantly more patients found the tablets to be less acceptable than the granules (76% vs. 33%, P=0.0005). The granules were preferable to the tablets when the 2 formulations were compared directly (73% vs. 21%, P=0.004), for their portability, size, and numbers of pills. The adherence rate was slightly better among patients taking the granules (94% vs. 91%) during the observation period, but the difference was not significant (P=0.139).
Conclusions
CR mesalazine granules are more acceptable than tablets, and may therefore be a better option for long-term medication.

Citations

Citations to this article as recorded by

Optimizing 5-aminosalicylate for moderate ulcerative colitis: expert recommendations from the Asia-Pacific, Middle East, and Africa Inflammatory Bowel Disease Coalition
Filiz Akyüz, Yoon Kyo An, Jakob Begun, Satimai Aniwan, Huu Hoang Bui, Webber Chan, Chang Hwan Choi, Nazeer Chopdat, Susan J Connor, Devendra Desai, Emma Flanagan, Taku Kobayashi, Allen Yu-Hung Lai, Rupert W Leong, Alex Hwong-Ruey Leow, Wai Keung Leung, Ju
Intestinal Research.2025; 23(1): 37. CrossRef
Non-Adherence Rate to Oral Mesalamine in Ulcerative Colitis Patients: A Systematic Review with Meta-Analysis
Cristiano Pagnini, Elisabetta Antonelli, Barbara Scrivo, Maria Cappello, Marco Soncini, Roberto Vassallo, Giammarco Mocci, Maria Carla Di Paolo
Journal of Personalized Medicine.2025; 15(4): 123. CrossRef
Shared decision-making improves adherence to mesalamine in ulcerative colitis: A prospective, multicenter, non-interventional cohort study in Germany
Wolfgang Kruis, Petra Jessen, Julia Morgenstern, Birgitta Reimers, Nike Müller-Grage, Bernd Bokemeyer
World Journal of Gastroenterology.2025;[Epub] CrossRef
Prospective Questionnaire Survey on Adherence to Oral 5‐Aminosalicylic Acid in Patients With Ulcerative Colitis
Tsuyoshi Beppu, Fumihito Hirai, Kensei Ohtsu, Masahiro Kishi, Teruyuki Takeda, Shigeyoshi Yasukawa, Noritaka Takatsu, Takashi Hisabe, Toshiharu Ueki, Kenshi Yao
JGH Open.2025;[Epub] CrossRef
Patent Landscaping of Time-dependent Mesalamine Prolonged-release Granules: A Case Study for Generic Formulation Development
Ayush Rohila, Ankit Kumar, Prakash Kumar Sirvi, Sadhana Dhyagala, Sakshi Kunjir, Rajkumar Malayandi
Journal of Pharmaceutical Innovation.2025;[Epub] CrossRef
Health-related quality of life, work productivity, and persisting challenges in treated ulcerative colitis patients: a Japanese National Health and Wellness Survey
Sakiko Hiraoka, Zhezhou Huang, Fei Qin, Fatima Megala Nathan Arokianathan, Kiran Davé, Shweta Shah, Hyunchung Kim
Intestinal Research.2025; 23(4): 524. CrossRef
Continuing or stopping 5‐aminosalicylates in patients with inflammatory bowel disease on anti‐TNF therapy: A nationwide population‐based study
Jeongkuk Seo, Seonok Kim, Seung Wook Hong, Sung Wook Hwang, Sang Hyoung Park, Dong‐Hoon Yang, Jeong‐Sik Byeon, Seung‐Jae Myung, Suk‐Kyun Yang, Ye‐Jee Kim, Byong Duk Ye
Alimentary Pharmacology & Therapeutics.2024; 60(3): 389. CrossRef
A review on taste masked multiparticulate dosage forms for paediatric
Khater AL-Japairai, Samah Hamed Almurisi, Abd Almonem Doolaanea, Syed Mahmood, Fawaz Alheibshy, Ahmed Alobaida, Nadiya Abdul-Halim, Bappaditya Chatterjee
International Journal of Pharmaceutics.2023; 632: 122571. CrossRef
Medication Formulation Preference of Mild and Moderate Ulcerative Colitis Patients: a European Survey
Xavier Hébuterne, Stephan R Vavricka, Helen C Thorne, Lara MacKenzie-Smith, Raphaël Laoun, Johan Burisch
Inflammatory Intestinal Diseases.2023; 8(1): 41. CrossRef
Efficacy and Safety of Vitamin D Adjuvant Therapy for Ulcerative Colitis: A Meta-Analysis
Xinyi Guo, Changxing Liu, Yahui Huang, Naeem Jan
Computational and Mathematical Methods in Medicine.2022; 2022: 1. CrossRef
Factors Associated with Self-reported Medication Adherence in Japanese Community-dwelling Elderly Individuals: The Nakajima Study
Natsuko Ishida, Yurina Tokumoto, Yukio Suga, Moeko Noguchi-Shinohara, Chiemi Abe, Sohshi Yuki-Nozaki, Ayaka Mori, Mai Horimoto, Koji Hayashi, Kazuo Iwasa, Masami Yokogawa, Mai Ishimiya, Hiroyuki Nakamura, Kiyonobu Komai, Ryo Matsushita, Junko Ishizaki, Ma
YAKUGAKU ZASSHI.2021; 141(5): 751. CrossRef
Treatment of inflammatory bowel diseases: focusing on 5-aminosalicylates and immunomodulators
You Sun Kim
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Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef
Association of Self-Reported Medication Adherence with Potentially Inappropriate Medications in Elderly Patients: A Cross-Sectional Pilot Study
Motoyasu Miyazaki, Masanobu Uchiyama, Yoshihiko Nakamura, Koichi Matsuo, Chika Ono, Miwa Goto, Ayako Unoki, Akio Nakashima, Osamu Imakyure
International Journal of Environmental Research and Public Health.2020; 17(16): 5940. CrossRef
Mesalazine granule formulation improves clinical data in Crohn's disease compared with tablet formulation
Satoshi Tamura, Natsuki Ishida, Takahiro Miyazu, Shunya Onoue, Shinya Tani, Mihoko Yamade, Yasushi Hamaya, Moriya Iwaizumi, Satoshi Osawa, Takahisa Furuta, Ken Sugimoto
Scientific Reports.2020;[Epub] CrossRef

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15 Crossref

IBD

Seven days triple therapy for eradication of Helicobacter pylori does not alter the disease activity of patients with inflammatory bowel disease: Shinichiro Shinzaki, Toshimitsu Fujii, Shigeki Bamba, Maiko Ogawa, Taku Kobayashi, Masahide Oshita, Hiroki Tanaka, Keiji Ozeki, Sakuma Takahashi, Hiroki Kitamoto, Kazuhito Kani, Sohachi Nanjo, Takeshi Sugaya, Yuko Sakakibara, Toshihiro Inokuchi, Kazuki Kakimoto, Akihiro Yamada, Hisae Yasuhara, Yoko Yokoyama, Takuya Yoshino, Akira Matsui, Misaki Nakamura, Taku Tomizawa, Ryosuke Sakemi, Noriko Kamata, Toshifumi Hibi; Intest Res 2018;16(4):609-618. Published online October 10, 2018; DOI: https://doi.org/10.5217/ir.2018.00044

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Background/Aims
The influences of Helicobacter pylori eradication therapy on the disease course of inflammatory bowel disease (IBD) are still unclear. We therefore conducted a multicenter, retrospective cohort study to evaluate the safety of H. pylori eradication therapy for IBD patients.
Methods
IBD patients with H. pylori eradication from 2005 to 2015 (eradication group) and control patients (non-eradication group; 2 paired IBD patients without H. pylori eradication matched with each eradicated patient) were included. IBD exacerbation (increased/additional IBD drug or IBD-associated hospitalization/surgery) and disease improvement based on the physicians’ global assessment were investigated at baseline, and at 2 and 6 months after eradication or observation.
Results
A total of 429 IBD (378 ulcerative colitis, 51 Crohn’s disease) patients, comprising 144 patients in the eradication group and 285 patients in the non-eradication group, were enrolled at 25 institutions. IBD exacerbation was comparable between groups (eradication group: 8.3% at 2 months [odds ratio, 1.76; 95% confidence interval, 0.78–3.92; P=0.170], 11.8% at 6 months [odds ratio, 1.60; 95% confidence interval, 0.81–3.11; P=0.172]). Based on the physicians’ global assessment at 2 months, none of the patients in the eradication group improved, whereas 3.2% of the patients in the non-eradication group improved (P=0.019). Multivariate analysis revealed that active disease at baseline, but not H. pylori eradication, was an independent factor for IBD exacerbation during 2 months’ observation period. The overall eradication rate was 84.0%–comparable to previous reports in non-IBD patients.
Conclusions
H. pylori eradication therapy does not alter the short-term disease activity of IBD.

Citations

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The Controversies in the Relationship Between Helicobacter pylori Infection and Inflammatory Bowel Disease: Narrative Review
Jonatan Vukovic, Ivana Jukic
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Helicobacter pylori and Inflammatory Bowel Disease: Unraveling the Complex Interactions and Clinical Implications
Elaheh Karimzadeh‐Soureshjani, Farab Pourhasan, Pouria Ahmadi Simab, Nabi Jomehzadeh, Ali Saeedi‐Boroujeni
JGH Open.2025;[Epub] CrossRef
Factors Associated With Decision to Treat or Not to Treat Helicobacter pylori Infection in Children: Data From the EuroPedHp Registry
Thu Giang Le Thi, Katharina Werkstetter, Kallirroi Kotilea, Patrick Bontems, José Cabral, Maria Luz Cilleruelo, Michal Kori, Josefa Barrio, Matjaž Homan, Nicolas Kalach, Rosa Lima, Marta Tavares, Pedro Urruzuno, Zrinjka Misak, Vaidotas Urbonas, Sibylle Ko
Helicobacter.2024;[Epub] CrossRef
Impact of Helicobacter pylori Eradication on Inflammatory Bowel Disease Onset and Disease Activity: To Eradicate or Not to Eradicate?
Antonietta Gerarda Gravina, Raffaele Pellegrino, Veronica Iascone, Giovanna Palladino, Alessandro Federico, Rocco Maurizio Zagari
Diseases.2024; 12(8): 179. CrossRef
Bibliometric analysis of the correlation between H. pylori and inflammatory bowel disease
Yantong Li, Limin Li, Wenmeng Yin, Juyi Wan, Xiaolin Zhong
JGH Open.2024;[Epub] CrossRef
Discussion on the common controversies of Helicobacter pylori infection
Hang Yang, Yi Mou, Bing Hu
Helicobacter.2023;[Epub] CrossRef
Helicobacter pylori and Inflammatory Bowel Disease: An Unresolved Enigma
Juris Pokrotnieks, Stanislav Sitkin
Inflammatory Bowel Diseases.2023; 29(3): e5. CrossRef
Helicobacter Pylori and Autoimmune Diseases: Involving Multiple Systems
Li Wang, Zheng-Min Cao, Li-Li Zhang, Xin-can Dai, Zhen-ju Liu, Yi-xian Zeng, Xin-Ye Li, Qing-Juan Wu, Wen-liang Lv
Frontiers in Immunology.2022;[Epub] CrossRef
Helicobacter pylori infection in patients with inflammatory bowel diseases: a single-centre, prospective, observational study in Egypt
Ekram W. Abd El-Wahab, Ebtessam I. Youssef, Ehab Hassouna
BMJ Open.2022; 12(5): e057214. CrossRef
Is the Presence of Helicobacter Pylori in the Colonic Mucosa, Provocative of Activity in Ulcerative Colitis?
Javad Ranjbar, Bita Geramizadeh, Kamran Bagheri Lankarani, Zahra Jowkar, Mitra Mirzai, Elham Moazamian
Clinical Pathology.2022;[Epub] CrossRef
Helicobacter pylori infection and inflammatory bowel diseases
Yu. P. Uspenskiy, N. V. Baryshnikova, A. N. Suvorov, A. V. Svarval
Russian Journal of Infection and Immunity.2021; 11(1): 68. CrossRef
Ulcerative colitis relapse after Helicobacter pylori eradication in a 12-year-old boy with duodenal ulcer
Yuji Fujita, Keiichi Tominaga, Takanao Tanaka, Takeshi Sugaya, Shigemi Yoshihara
BMC Gastroenterology.2021;[Epub] CrossRef
Effect of sequential eradication therapy on serum osteoprotegerin levels in patients with Helicobacter pylori infection and co-existing inflammatory bowel disease
Hussam Murad, Misbahuddin Rafeeq, Mahmoud Mosli, Mamdouh Gari, Mohammed Basheikh
Journal of International Medical Research.2021;[Epub] CrossRef
Extra-Gastric Manifestations of Helicobacter pylori Infection
Antonietta G. Gravina, Kateryna Priadko, Paola Ciamarra, Lucia Granata, Angela Facchiano, Agnese Miranda, Marcello Dallio, Alessandro Federico, Marco Romano
Journal of Clinical Medicine.2020; 9(12): 3887. CrossRef
Comparison of new and classical point mutations associated with clarithromycin resistance in Helicobacter pylori strains isolated from dyspeptic patients and their effects on phenotypic clarithromycin resistance
Bekir Kocazeybek, Merve Kutlu Sakli, Pelin Yuksel, Mehmet Demirci, Reyhan Caliskan, Tevhide Ziver Sarp, Suat Saribas, Suleyman Demiryas, Fatma Kalayci, Huseyin Cakan, Hayriye Kirkoyun Uysal, Nesrin Gareayaghi, Sevgi Ergin, Yusuf Ziya Erzin, Kadir Bal, İhs
Journal of Medical Microbiology .2019; 68(4): 566. CrossRef
Review:Helicobacter pyloriand extragastric diseases
Francesco Franceschi, Marcello Covino, Claire Roubaud Baudron
Helicobacter.2019;[Epub] CrossRef

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Case Report

IBD

5-Aminosalicylic acid aggravates colitis mimicking exacerbation of ulcerative colitis: Jun Miyoshi, Katsuyoshi Matsuoka, Atsushi Yoshida, Makoto Naganuma, Tadakazu Hisamatsu, Tomoharu Yajima, Nagamu Inoue, Susumu Okamoto, Yasushi Iwao, Haruhiko Ogata, Fumiaki Ueno, Toshifumi Hibi, Takanori Kanai; Intest Res 2018;16(4):635-640. Published online October 10, 2018; DOI: https://doi.org/10.5217/ir.2018.00015

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Ulcerative colitis (UC) is one of the major clinical phenotypes of inflammatory bowel diseases. Although 5-aminosalicylic acid (5-ASA) is widely used for UC and its efficacy and safety have been demonstrated, a few patients paradoxically develop a severe exacerbation of colitis by 5-ASA administration. It is crucial to know clinical features including endoscopic findings in this condition for making a correct diagnosis and a prompt decision to withdraw the medication. Here, we report case series with UC exacerbated by 5-ASA. Medical records of 8 UC patients experiencing an exacerbation of colitis after induction of 5-ASA that was improved by the withdrawal of 5-ASA but also re-aggravated by dose increase or re-administration of 5-ASA were reviewed. The patients were newly diagnosed with UC, started 5-ASA and developed an exacerbation in approximately 2 to 3 weeks. They did not appear to have systemic allergic reactions. Seven of the 8 patients had a high fever. Three of 5 patients who undertook total colonoscopy showed right-side-dominant colitis. These findings suggest clinical characteristics in this condition. Further assessment of clinical and endoscopic features in more cases is necessary for establishing diagnostic criteria and understanding underlying mechanisms in those cases where 5-ASA aggravates the colitis.

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Hiroshi Matsumoto, Momoyo Sasahira, Tei Tei Go, Shogen Yo, Takehiro Ninomiya, Motoyasu Osawa, Osamu Handa, Eiji Umegami, Ryo Inoue, Akiko Shiotani
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Naoki Abe, Naomi Iwata, Ryuhei Yasuoka, Daisuke Nishida, Asami Oohara, Haruna Nakaseko, Shiro Sugiura, Shinji Kawabe
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Corrigenda and Errata

Corrigendum: Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies: Satoshi Motoya, Mamoru Watanabe, Hyo Jong Kim, Young Ho Kim, Dong Soo Han, Hirotoshi Yuasa, Junichi Tabira, Naoki Isogawa, Shoko Arai, Isao Kawaguchi, Toshifumi Hibi; Intest Res 2018;16(3):499-501. Published online July 27, 2018; DOI: https://doi.org/10.5217/ir.2018.16.3.499

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Brief Communication

IBD

Effect of elemental diet combined with infliximab dose escalation in patients with Crohn's disease with loss of response to infliximab: CERISIER trial: Tadakazu Hisamatsu, Reiko Kunisaki, Shiro Nakamura, Tomoyuki Tsujikawa, Fumihito Hirai, Hiroshi Nakase, Kenji Watanabe, Kaoru Yokoyama, Masakazu Nagahori, Takanori Kanai, Makoto Naganuma, Hirofumi Michimae, Akira Andoh, Akihiro Yamada, Tadashi Yokoyama, Noriko Kamata, Shinji Tanaka, Yasuo Suzuki, Toshifumi Hibi, Mamoru Watanabe; Intest Res 2018;16(3):494-498. Published online July 27, 2018; DOI: https://doi.org/10.5217/ir.2018.16.3.494

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Original Articles

IBD

Comparison of efficacy of once daily multimatrix mesalazine 2.4 g/day and 4.8 g/day with other 5-aminosalicylic acid preparation in active ulcerative colitis: a randomized, double-blind study: Haruhiko Ogata, Tadashi Yokoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2018;16(2):255-266. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.255

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

This study compared the efficacy of multimatrix mesalazine 2.4 g/day and 4.8 g/day with controlled-release mesalazine 2.25 g/day.

Methods

In this multicenter, randomized, double-blind study, 251 patients with mildly to moderately active ulcerative colitis received multimatrix mesalazine 2.4 g/day once daily (Multimatrix-2.4), 4.8 g/day once daily (Multimatrix-4.8), or controlled-release (time-dependent) mesalazine 2.25 g/day 3 times daily (Time-2.25) for 8 weeks. The primary efficacy endpoint was the change in the ulcerative colitis-disease activity index (UC-DAI) score.

Results

The mean change in the UC-DAI score and standard deviation in the per protocol set was −1.9±2.5 for Multimatrix-2.4 and −2.4±2.8 for Time-2.25. The difference between Multimatrix-2.4 and Time-2.25 was 0.3 (two-sided 95% confidence interval [CI], −0.5 to 1.1), thus non-inferiority was not demonstrated based on the pre-defined non-inferiority margin (1.0). In the full analysis set, the difference between Multimatrix-4.8 and Time-2.25 was −1.2 (two-sided 95% CI, −2.0 to −0.5), and the mean change in UC-DAI score in the FAS was −3.3 (two-sided 95% CI, −3.9 to −2.8) for Multimatrix-4.8 and −1.9 (two-sided 95% CI, −2.5 to −1.3) for Multimatrix-2.4, indicating that Multimatrix-4.8 was more effective than Time-2.25 and Multimatrix-2.4. There was no difference among the treatment groups in terms of safety.

Conclusions

This study showed that the efficacy of multimatrix mesalazine 2.4 g/day was comparable to controlled release mesalazine 2.25 g/day, although non-inferiority was not demonstrated. Importantly, this was the first study to indicate that multimatrix mesalazine 4.8 g/day was more effective than 2.4g/day with no associated safety concerns.

Citations

Citations to this article as recorded by

The gut wall’s potential as a partner for precision oncology in immune checkpoint treatment
Sara Hone Lopez, Mathilde Jalving, Rudolf S.N. Fehrmann, Wouter B. Nagengast, Elisabeth G.E. de Vries, Jacco J. de Haan
Cancer Treatment Reviews.2022; 107: 102406. CrossRef
Differential effects of mesalazine formulations on thiopurine metabolism through thiopurine S‐methyltransferase inhibition
Hiromu Morikubo, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Satoshi Kuronuma, Osamu Takeuchi, Tenyo Shiba, Hiroki Kiyohara, Mao Matsubayashi, Shintaro Sagami, Masaru Nakano, Osamu Ikezaki, Tadakazu Hisamatsu, Yoichi Tanaka, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2021; 36(8): 2116. CrossRef
Efficacy of Oral, Topical, or Combined Oral and Topical 5-Aminosalicylates, in Ulcerative Colitis: Systematic Review and Network Meta-analysis
Brigida Barberio, Jonathan P Segal, M Nabil Quraishi, Christopher J Black, Edoardo V Savarino, Alexander C Ford
Journal of Crohn's and Colitis.2021; 15(7): 1184. CrossRef
Evidence-based clinical practice guidelines for inflammatory bowel disease 2020
Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
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Daniel R van Langenberg, Richard Kai-Yuan Cheng, Mayur Garg
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Comparative assessment of budesonide‐MMX and mesalamine in active, mild‐to‐moderate ulcerative colitis: A systematic review and network meta‐analysis
Stefanos Bonovas, Georgios K. Nikolopoulos, Daniele Piovani, Marien González‐Lorenzo, Katerina Pantavou, Theodore Lytras, Laurent Peyrin‐Biroulet, Silvio Danese
British Journal of Clinical Pharmacology.2019; 85(10): 2244. CrossRef
Switching between Three Types of Mesalazine Formulation and Sulfasalazine in Patients with Active Ulcerative Colitis Who Have Already Received High-Dose Treatment with These Agents
Eriko Yasutomi, Sakiko Hiraoka, Shumpei Yamamoto, Shohei Oka, Mami Hirai, Yasushi Yamasaki, Toshihiro Inokuchi, Hideaki Kinugasa, Masahiro Takahara, Keita Harada, Jun Kato, Hiroyuki Okada
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Is once daily multimatrix mesalazine therapy effective regardless of the dose in patients with mild to moderate ulcerative colitis?
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IBD

Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies: Satoshi Motoya, Mamoru Watanabe, Hyo Jong Kim, Young Ho Kim, Dong Soo Han, Hirotoshi Yuasa, Junichi Tabira, Naoki Isogawa, Shoko Arai, Isao Kawaguchi, Toshifumi Hibi; Intest Res 2018;16(2):233-245. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.233

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

Tofacitinib is an oral, small-molecule Janus kinase inhibitor being investigated for ulcerative colitis (UC). In OCTAVE Induction 1 and 2, patients with moderately to severely active UC received placebo or tofacitinib 10 mg twice daily (BID) for 8 weeks. Clinical responders in OCTAVE Induction were re-randomized to 52 weeks' therapy with placebo, tofacitinib 5 mg BID, or tofacitinib 10 mg BID.

Methods

We conducted post-hoc efficacy and safety analyses of East Asian patients in OCTAVE Induction 1 and 2 and OCTAVE Sustain.

Results

A total of 121 East Asian (Japan, Korea, and Taiwan) patients were randomized in OCTAVE Induction 1 and 2 (placebo, n=26; tofacitinib 10 mg BID, n=95), and 63 in OCTAVE Sustain (placebo, n=20; tofacitinib 5 mg BID, n=22; tofacitinib 10 mg BID, n=21). At week 8 of OCTAVE Induction 1 and 2, 18.9% of patients (18/95) achieved remission with tofacitinib 10 mg BID versus 3.8% (1/26) with placebo. In OCTAVE Sustain, the week 52 remission rates were 45.5% (10/22), 47.6% (10/21), and 15.0% (3/20) with 5 mg BID, 10 mg BID, and placebo, respectively. Adverse event rates were similar between groups in OCTAVE Induction and numerically higher with tofacitinib in OCTAVE Sustain. Serious adverse event rates were similar across groups in all studies. Infections were numerically more frequent with tofacitinib than placebo. Increases in serum lipid levels were observed with tofacitinib.

Conclusions

In East Asian patients with UC, tofacitinib demonstrated numerically greater efficacy versus placebo as induction and maintenance therapy, with a safety profile consistent with the global study population. ClinicalTrials.gov: NCT01465763; NCT01458951; NCT01458574.

Citations

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Statement

IBD

Predicting outcomes to optimize disease management in inflammatory bowel disease in Japan: their differences and similarities to Western countries: Taku Kobayashi, Tadakazu Hisamatsu, Yasuo Suzuki, Haruhiko Ogata, Akira Andoh, Toshimitsu Araki, Ryota Hokari, Hideki Iijima, Hiroki Ikeuchi, Yoh Ishiguro, Shingo Kato, Reiko Kunisaki, Takayuki Matsumoto, Satoshi Motoya, Masakazu Nagahori, Shiro Nakamura, Hiroshi Nakase, Tomoyuki Tsujikawa, Makoto Sasaki, Kaoru Yokoyama, Naoki Yoshimura, Kenji Watanabe, Miiko Katafuchi, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2018;16(2):168-177. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.168

Abstract PDF PubReader ePub

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), is a chronic inflammatory disease of the gastrointestinal tract, with increasing prevalence worldwide. IBD Ahead is an international educational program that aims to explore questions commonly raised by clinicians about various areas of IBD care and to consolidate available published evidence and expert opinion into a consensus for the optimization of IBD management. Given differences in the epidemiology, clinical and genetic characteristics, management, and prognosis of IBD between patients in Japan and the rest of the world, this statement was formulated as the result of literature reviews and discussions among Japanese experts as part of the IBD Ahead program to consolidate statements of factors for disease prognosis in IBD. Evidence levels were assigned to summary statements in the following categories: disease progression in CD and UC; surgery, hospitalization, intestinal failure, and permanent stoma in CD; acute severe UC; colectomy in UC; and colorectal carcinoma and dysplasia in IBD. The goal is that this statement can aid in the optimization of the treatment strategy for Japanese patients with IBD and help identify high-risk patients that require early intervention, to provide a better long-term prognosis in these patients.

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Special Review

IBD

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 1: risk assessment: Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang; Intest Res 2018;16(1):4-16. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.4

Abstract PDF PubReader ePub

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 1 of the statements comprised 2 parts: risk of TB infection Recommendaduring anti-TNF therapy, and screening for TB infection prior to commencing anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

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Development of Spinal Tuberculosis in an Adolescent With Crohn's Disease After Infliximab Therapy: A Case Report With Literature Review
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Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study
Haruhiko Ogata, Takashi Hagiwara, Takeshi Kawaberi, Mariko Kobayashi, Toshifumi Hibi
Intestinal Research.2021; 19(4): 419. CrossRef
Targeted versus universal tuberculosis chemoprophylaxis in 1968 patients with inflammatory bowel disease receiving anti‐TNF therapy in a tuberculosis endemic region
Lingna Ye, Thomas P. Chapman, Zhenzhen Wen, Lang Lin, Yun Qiu, Zhanju Liu, Zhihua Ran, Jiaming Qian, Kaichun Wu, Xiang Gao, Pinjin Hu, Minhu Chen, Simon P. L. Travis, Qian Cao
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Rupa Banerjee, Raja Affendi Raja Ali, Shu Chen Wei, Shashi Adsul
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Increased Risk of Herpes Zoster in Young and Metabolically Healthy Patients with Inflammatory Bowel Disease: A Nationwide Population-Based Study
Hosim Soh, Jaeyoung Chun, Kyungdo Han, Seona Park, Gukhwan Choi, Jihye Kim, Jooyoung Lee, Jong Pil Im, Joo Sung Kim
Gut and Liver.2019; 13(3): 333. CrossRef
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Mafalda Sousa, Inês Ladeira, Ana Ponte, Carlos Fernandes, Adélia Rodrigues, Ana P. Silva, João Silva, Catarina Gomes, Edgar Afeto, João Carvalho
European Journal of Gastroenterology & Hepatology.2019; 31(9): 1099. CrossRef
The Use of Biologics and Biosimilar in Asian patients with IBD: Are we ready?
Joyce WY Mak, Joseph JY Sung
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Comparison of outcomes of continuation/discontinuation of 5-aminosalicylic acid after initiation of anti-tumor necrosis factor-alpha therapy in patients with inflammatory bowel disease
Youn I Choi, Tae Jun Kim, Dong Kyun Park, Jun-won Chung, Kyoung Oh Kim, Kwang An Kwon, Yoon Jae Kim
International Journal of Colorectal Disease.2019; 34(10): 1713. CrossRef
Multidrug-resistant Disseminated Tuberculosis Related to Infliximab in a Patient with Ulcerative Colitis and Negative Evaluation for Latent Tuberculosis
Yu Kyung Jun, Jaeyoung Chun, Eun Ae Kang, Hyun Jung Lee, Jong Pil Im, Joo Sung Kim
The Korean Journal of Gastroenterology.2019; 74(3): 168. CrossRef
Evidence-based consensus on opportunistic infections in inflammatory bowel disease (republication)

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High risk of tuberculosis during infliximab therapy despite tuberculosis screening in inflammatory bowel disease patients in India
Ashish Agarwal, Saurabh Kedia, Saransh Jain, Vipin Gupta, Sawan Bopanna, Dawesh P Yadav, Sandeep Goyal, Venigalla Pratap Mouli, Rajan Dhingra, Govind Makharia, Vineet Ahuja
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Risk of infection associated with anti-TNF-α therapy
Mario Fernández-Ruiz, José María Aguado
Expert Review of Anti-infective Therapy.2018; 16(12): 939. CrossRef

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Special Review: Consensus on TB in IBD

IBD

Asian Organization for Crohn's and Colitis and Asia Pacific Association of Gastroenterology consensus on tuberculosis infection in patients with inflammatory bowel disease receiving anti-tumor necrosis factor treatment. Part 2: management: Dong Il Park, Tadakazu Hisamatsu, Minhu Chen, Siew Chien Ng, Choon Jin Ooi, Shu Chen Wei, Rupa Banerjee, Ida Normiha Hilmi, Yoon Tae Jeen, Dong Soo Han, Hyo Jong Kim, Zhihua Ran, Kaichun Wu, Jiaming Qian, Pin-Jin Hu, Katsuyoshi Matsuoka, Akira Andoh, Yasuo Suzuki, Kentaro Sugano, Mamoru Watanabe, Toshifumi Hibi, Amarender S. Puri, Suk-Kyun Yang; Intest Res 2018;16(1):17-25. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.17

Abstract PDF PubReader ePub

Because anti-tumor necrosis factor (anti-TNF) therapy has become increasingly popular in many Asian countries, the risk of developing active tuberculosis (TB) among anti-TNF users may raise serious health problems in this region. Thus, the Asian Organization for Crohn's and Colitis and the Asia Pacific Association of Gastroenterology have developed a set of consensus statements about risk assessment, detection and prevention of latent TB infection, and management of active TB infection in patients with inflammatory bowel disease (IBD) receiving anti-TNF treatment. Twenty-three consensus statements were initially drafted and then discussed by the committee members. The quality of evidence and the strength of recommendations were assessed by using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Web-based consensus voting was performed by 211 IBD specialists from 9 Asian countries concerning each statement. A consensus statement was accepted if at least 75% of the participants agreed. Part 2 of the statements comprised 3 parts: management of latent TB in preparation for anti-TNF therapy, monitoring during anti-TNF therapy, and management of an active TB infection after anti-TNF therapy. These consensus statements will help clinicians optimize patient outcomes by reducing the morbidity and mortality related to TB infections in patients with IBD receiving anti-TNF treatment.

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Risk of Tuberculosis and Hepatitis B Reactivation in Patients With Crohn’s Disease on Ustekinumab: A Nationwide Real-World Study
Rongbei Liu, Zhilun Li, Lingna Ye, Jing Hu, Jian Tang, Baili Chen, Xiuli Chen, Bei Tan, Yubei Gu, Chen Xie, Chunhui Ouyang, Xiaomei Song, Fan Li, Yanyun Fan, Haixia Ren, Liangru Zhu, Min Chen, Wenyu Jiang, Qian Cao
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Reduced gut microbiota diversity in ulcerative colitis patients with latent tuberculosis infection during vedolizumab therapy: insights on prophylactic anti-tuberculosis effects
Yibing Hu, Zhenping Wu, Xiaoyun Yang, Jin Ding, Qunying Wang, Hao Fang, Lujian Zhu, Minli Hu
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Medical management of pediatric inflammatory bowel disease in the Asia‐Pacific region: A position paper by the Asian Pan‐Pacific Society for Pediatric Gastroenterology, Hepatology, and Nutrition (APPSPGHAN) PIBD Working Group
Way Seah Lee, Katsuhiro Arai, George Alex, Suporn Treepongkaruna, Kyung Mo Kim, Chee Liang Choong, Karen S. C. Mercado, Andy Darma, Anshu Srivastava, Marion M. Aw
Journal of Gastroenterology and Hepatology.2023; 38(4): 523. CrossRef
Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis
Soo-Young Na, Chang Hwan Choi, Eun Mi Song, Ki Bae Bang, Sang Hyoung Park, Eun Soo Kim, Jae Jun Park, Bora Keum, Chang Kyun Lee, Bo-In Lee, Seung-Bum Ryoo, Seong-Joon Koh, Miyoung Choi, Joo Sung Kim
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Shruti Verma, Arshdeep Singh, Chandan Kakkar, Ashish Tripathi, Vandana Midha, Ajit Sood
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Jae Hoon Jung, Sujin Choi, Youra Kang, Dae-Chul Cho, So Mi Lee, Tae In Park, Byung-Ho Choe, Dongsub Kim, Ben Kang
Frontiers in Pediatrics.2022;[Epub] CrossRef
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Shuhei Hosomi, Naoko Sugita, Atsushi Kanamori, Masaki Ominami, Koji Otani, Noriko Kamata, Fumio Tanaka, Yasuaki Nagami, Koichi Taira, Yasuhiro Fujiwara
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Prophylactic Antitubercular Therapy Is Associated With Accelerated Disease Progression in Patients With Crohn's Disease Receiving Anti-TNF Therapy: A Retrospective Multicenter Study
Fen Liu, Jian Tang, Lingna Ye, Jinyu Tan, Yun Qiu, Fan Hu, Jinshen He, Baili Chen, Yao He, Zhirong Zeng, Ren Mao, Qian Cao, Xiang Gao, Minhu Chen
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Suk-Kyun Yang
Journal of the Korean Medical Association.2021; 64(9): 572. CrossRef
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Yunho Jung
The Korean Journal of Gastroenterology.2020; 75(1): 1. CrossRef
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Jihye Kim, Jong Pil Im, Jae-Joon Yim, Chang Kyun Lee, Dong Il Park, Chang Soo Eun, Sung-Ae Jung, Jeong Eun Shin, Kang-Moon Lee, Jae Hee Cheon
The Korean Journal of Gastroenterology.2020; 75(1): 29. CrossRef
Preoperative hypoalbuminemia is an independent risk factor for postoperative complications in Crohn's disease patients with normal BMI: A cohort study
Xiaolong Ge, Huaying Liu, Shasha Tang, Yan Wu, Yipeng Pan, Wei Liu, Weilin Qi, Lingna Ye, Qian Cao, Wei Zhou
International Journal of Surgery.2020; 79: 294. CrossRef
Biologics for the Management of Inflammatory Bowel Disease: A Review in Tuberculosis-Endemic Countries
Rupa Banerjee, Raja Affendi Raja Ali, Shu Chen Wei, Shashi Adsul
Gut and Liver.2020; 14(6): 685. CrossRef
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Youn I Choi, Tae Jun Kim, Dong Kyun Park, Jun-won Chung, Kyoung Oh Kim, Kwang An Kwon, Yoon Jae Kim
International Journal of Colorectal Disease.2019; 34(10): 1713. CrossRef
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Susan V. Lynch, Siew C. Ng, Fergus Shanahan, Herbert Tilg
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Yu Kyung Jun, Jaeyoung Chun, Eun Ae Kang, Hyun Jung Lee, Jong Pil Im, Joo Sung Kim
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A rare case of disseminated histoplasmosis in a patient with Crohn’s disease on immunosuppressive treatment
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High risk of tuberculosis during infliximab therapy despite tuberculosis screening in inflammatory bowel disease patients in India
Ashish Agarwal, Saurabh Kedia, Saransh Jain, Vipin Gupta, Sawan Bopanna, Dawesh P Yadav, Sandeep Goyal, Venigalla Pratap Mouli, Rajan Dhingra, Govind Makharia, Vineet Ahuja
Intestinal Research.2018; 16(4): 588. CrossRef

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Case Report

Steroid-refractory extensive enteritis complicated by ulcerative colitis successfully treated with adalimumab: Shinji Okabayashi, Taku Kobayashi, Tomohisa Sujino, Ryo Ozaki, Satoko Umeda, Takahiko Toyonaga, Eiko Saito, Masaru Nakano, Maria Carla Tablante, Shojiroh Morinaga, Toshifumi Hibi; Intest Res 2017;15(4):535-539. Published online October 23, 2017; DOI: https://doi.org/10.5217/ir.2017.15.4.535

Abstract PDF PubReader ePub

Extracolonic involvement of the gastrointestinal tract is extremely uncommon in ulcerative colitis (UC) and rarely found in the upper gastrointestinal tract or in postoperative cases since it typically responds to steroids. Here we report a case of UC complicated by extensive ileal inflammation that was refractory to steroids. A 20-year-old man was diagnosed with UC of typical pancolitis without ileal involvement and started treatment with pH-dependent mesalazine and oral prednisolone. Although his symptoms transiently resolved, the condition flared when the steroid dose was tapered down. Computed tomography revealed marked thickening of the ileal wall, and capsule endoscopy and balloon-assisted enteroscopy found diffuse mucosal inflammation with ulcers in the ileum. On the contrary, the inflammation in the colon and rectum was improving. Since the response to the second steroid course was inadequate, treatment with adalimumab and 6-mercaptopurine was initiated and finally achieved clinical and endoscopic remission. The investigation of small intestinal lesions is necessary in patients with UC whose clinical deterioration cannot be explained by colonic lesions.

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A case of relapsed pan-colonic ulcerative colitis accompanied with gastroduodenal lesions immediately after COVID-19
Katsuya Endo, Tomonori Satoh, Yuki Yoshino, Shiho Kondo, Yoko Kawakami, Daisuke Fukushi, Atsuko Takasu, Takayuki Kogure, Morihisa Hirota, Kennichi Satoh
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3 Web of Science
2 Crossref

Original Articles

Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies: Toshifumi Hibi, Yuya Imai, Yoko Murata, Nobuko Matsushima, Richuan Zheng, Christopher Gasink; Intest Res 2017;15(4):475-486. Published online October 23, 2017; DOI: https://doi.org/10.5217/ir.2017.15.4.475

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population.

Methods

Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0. Responders to ustekinumab induction therapy (Japan, n=21) were randomized to placebo or ustekinumab (90 mg, subcutaneous) maintenance (every 12 weeks [q12w] or 8 weeks [q8w]) in IM-UNITI. The primary endpoint was clinical response at week 6 for induction studies and clinical remission at week 44 for maintenance study.

Results

Percentage of patients achieving clinical response at week 6 was greater in ustekinumab 130 mg and ~6 mg/kg groups than in the placebo group (UNITI-1: 36.8% and 31.6% vs. 27.8%, respectively, for Japanese; 34.3% and 33.7% vs. 21.5%, respectively, for overall; UNITI-2: 37.5% and 55.6% vs. 11.1%, respectively, for Japanese; 51.7% and 55.5% vs. 28.7%, respectively, for overall). Clinical remission rate at week 44 during maintenance was greater in the ustekinumab 90 mg SC q12w and q8w groups than in the placebo group (50.0% and 55.6% vs. 25.0%, respectively, for Japanese; 48.8% and 53.1% vs. 35.9%, respectively, for overall). Efficacy and safety results observed in the Japanese subpopulation were generally consistent with those in the overall population.

Conclusions

Ustekinumab could be considered as a new therapeutic option for moderately to severely active CD in Japanese patients. Both ustekinumab induction and maintenance treatments were generally well tolerated (Clinical Trial Registration: NCT01369329, NCT01369342, NCT01369355).

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Yanfang Liu, Choo Hua Goh, Hong Qiu, Kuan-Chih Huang, Hsingwen Chung, Carine Saadoun
Annals of Pharmacotherapy.2023; 57(9): 1053. CrossRef
Real-world effectiveness and safety of ustekinumab induction therapy for Korean patients with Crohn’s disease: a KASID prospective multicenter study
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A critical review of ustekinumab for the treatment of active ulcerative colitis in adults
Sophie Vieujean, Edouard Louis, Silvio Danese, Laurent Peyrin-Biroulet
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Feasibility of a Clinical Decision Support Tool for Ustekinumab to Predict Clinical Remission and Relapse in Patients With Crohn’s Disease: A Multicenter Observational Study
Jihye Park, Jaeyoung Chun, Hyuk Yoon, Jae Hee Cheon
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Soo-Young Na, You Sun Kim
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Shirley Cohen-Mekelburg, Beth I. Wallace, Tony Van, Wyndy L. Wiitala, Shail M. Govani, Jennifer Burns, Rachel Lipson, Huifeng Yun, Jason Hou, James D. Lewis, Jason A. Dominitz, Akbar K. Waljee
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Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
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Safety and effectiveness of ustekinumab in Crohn's disease: Interim results of post‐marketing surveillance in Japan
Seiji Yokoyama, Teita Asano, Katsumasa Nagano, Hiroaki Tsuchiya, Masayuki Takagishi, Shigeharu Tsujioka, Naomi Miura, Takayuki Matsumoto
Journal of Gastroenterology and Hepatology.2021; 36(11): 3069. CrossRef
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Sushmita Negi, Sheetal Saini, Nikunj Tandel, Kiran Sahu, Ravi P.N. Mishra, Rajeev K. Tyagi
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Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI)
Tadakazu Hisamatsu, Hyo Jong Kim, Satoshi Motoya, Yasuo Suzuki, Yoshifumi Ohnishi, Noriyuki Fujii, Nobuko Matsushima, Richuan Zheng, Colleen W. Marano
Intestinal Research.2021; 19(4): 386. CrossRef
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Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
Intestinal Research.2021; 19(4): 448. CrossRef
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Ahmad Ismail Khaled Abdo, Gee Jun Tye
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Takahiro Ito, Atsuo Maemoto, Takehiko Katsurada, Hiroki Tanaka, Satoshi Motoya, Nobuhiro Ueno, Mikihiro Fujiya, Toshifumi Ashida, Daisuke Hirayama, Hiroshi Nakase
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Sadik Saman, Martin Goetz, Judith Wendler, Nisar P. Malek, Jan Wehkamp, Thomas Klag
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Sarah C Davies, Tran M Nguyen, Claire E Parker, John K MacDonald, Vipul Jairath, Reena Khanna
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Hyo Sun Lee, Soo-Kyung Park, Dong Il Park
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21 Crossref

Long-term safety and efficacy of adalimumab for intestinal Behçet's disease in the open label study following a phase 3 clinical trial: Nagamu Inoue, Kiyonori Kobayashi, Makoto Naganuma, Fumihito Hirai, Morio Ozawa, Dilek Arikan, Bidan Huang, Anne M. Robinson, Roopal B. Thakkar, Toshifumi Hibi; Intest Res 2017;15(3):395-401. Published online June 12, 2017; DOI: https://doi.org/10.5217/ir.2017.15.3.395

Abstract PDF PubReader ePub

Background/Aims

Intestinal Behçet's disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671).

Methods

Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments.

Results

Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively.

Conclusions

This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity.

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Tianjiao Gao, Xiaoxia Ren, Yanan Han, Fengfan Wang, Bianhua Liu, Ying Fang
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Masaaki Uehara, Shinya Matsushita, Satsuki Aochi, Motohisa Yamamoto
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Shun Fujiwara, Ami Kawamoto, Maiko Motobayashi, Shuji Hibiya, Kento Takenaka, Hiromichi Shimizu, Eiko Saito, Toshimitsu Fujii, Masakazu Nagahori, Daisuke Kawata, Natsuka Umezawa, Tadashi Hosoya, Shinsuke Yasuda, Kazuo Ohtsuka, Ryuichi Okamoto
DEN Open.2023;[Epub] CrossRef
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Teresa Giani, Angela Flavia Luppino, Giovanna Ferrara
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Gut and Liver.2023; 17(5): 777. CrossRef
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Jongwook Yu, Sung Jae Shin, Yune-Jung Park, Hyung Wook Kim, Bo-In Lee, Byong Duk Ye, Geun-Tae Kim, Sung Kook Kim, Joo Sung Kim, Young-Ho Kim, Seonjeong Jeong, Jae Hee Cheon
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Efficacy and predictor of anti-TNFα agents in patients with intestinal Behçet's disease
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Petros Efthimiou, Olga Petryna, Priscila Nakasato, Apostolos Kontzias
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Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study: Haruhiko Ogata, Nobuo Aoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2017;15(3):368-379. Published online June 12, 2017; DOI: https://doi.org/10.5217/ir.2017.15.3.368

Abstract PDF PubReader ePub

Background/Aims

This study assessed the efficacy and safety of high-dose multimatrix mesalazine once-daily (QD) compared to another form of high-dose mesalazine.

Methods

In this multicenter, randomized, double-blind study, 280 patients with mildly to moderately active ulcerative colitis (UC) received multimatrix mesalazine 4.8 g/day QD or pH-dependent-release mesalazine 3.6 g/day three times daily for 8 weeks. The primary endpoint was the change in the UC-Disease Activity Index (UC-DAI) at the end of the treatment period.

Results

The change in the UC-DAI (mean±standard deviation) in the per-protocol set was −2.6±2.47 in the multimatrix mesalazine 4.8 g/day group (n=134) and −1.8±2.64 in the pH-dependent-release mesalazine 3.6 g/day group (n=129). The difference in the mean change between the 2 groups was −0.7 (two-sided 95% confidence interval, −1.3 to −0.1). The noninferiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was verified within the noninferiority margin (1.1). The superiority of multimatrix mesalazine 4.8 g/day to pH-dependent-release mesalazine 3.6 g/day was also investigated and confirmed in the full analysis set, according to the study protocol. In subgroup analyses, the effectiveness of multimatrix mesalazine 4.8 g/day was consistent in all subgroups. There was no difference in safety between the 2 treatment groups.

Conclusions

Multimatrix mesalazine 4.8 g/day has higher efficacy and shows no difference in safety in mildly to moderately active UC, in comparison with pH-dependent-release mesalazine 3.6 g/day.

Citations

Citations to this article as recorded by

Long-Term Efficacy and Safety of Multi-Matrix Mesalazine Maintenance Therapy in Pediatric Patients with Ulcerative Colitis
Toshiaki Shimizu, Daisuke Tokuhara, Shigeo Nishimata, Takashi Ishige, Takahiro Kudo, Masahiro Takatsu, Kanako Nishimura, Akiko Matsuda, Koichi Hayashi, Katsuhiro Arai
Pediatric Gastroenterology, Hepatology & Nutrition.2026; 29(1): 44. CrossRef
Analysis of the Medication Persistence Rate for and Adherence to Oral 5-Aminosalicylic Acid Preparations in Japanese Patients with Ulcerative Colitis: Study Using a Nationwide Claims Database
Takumi Ota, Takahiro Takebe, Yutaka Shimizu, Takashi Orido, Hiroyuki Tanaka, Shiro Nakamura
Digestion.2024; 105(3): 232. CrossRef
5-Aminosalicylic Acid Distribution into the Intestinal Membrane Along the Gastrointestinal Tract After Oral Administration in Rats
Yorinobu Maeda, Yuta Goto, Fumiya Ohnishi, Syoutarou Koga, Satoshi Kawano, Yuhzo Hieda, Takeshi Goromaru, Teruo Murakami
Pharmaceutics.2024; 16(12): 1567. CrossRef
Differential effects of mesalazine formulations on thiopurine metabolism through thiopurine S‐methyltransferase inhibition
Hiromu Morikubo, Taku Kobayashi, Ryo Ozaki, Shinji Okabayashi, Satoshi Kuronuma, Osamu Takeuchi, Tenyo Shiba, Hiroki Kiyohara, Mao Matsubayashi, Shintaro Sagami, Masaru Nakano, Osamu Ikezaki, Tadakazu Hisamatsu, Yoichi Tanaka, Toshifumi Hibi
Journal of Gastroenterology and Hepatology.2021; 36(8): 2116. CrossRef
Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis
Tong Wang, Hua Lu, Fangyuan Li, Qi Zhang
Medicine.2021; 100(5): e23915. CrossRef
Evidence-based clinical practice guidelines for inflammatory bowel disease 2020
Hiroshi Nakase, Motoi Uchino, Shinichiro Shinzaki, Minoru Matsuura, Katsuyoshi Matsuoka, Taku Kobayashi, Masayuki Saruta, Fumihito Hirai, Keisuke Hata, Sakiko Hiraoka, Motohiro Esaki, Ken Sugimoto, Toshimitsu Fuji, Kenji Watanabe, Shiro Nakamura, Nagamu I
Journal of Gastroenterology.2021; 56(6): 489. CrossRef
Efficacy of Multi Matrix System Mesalazine for the Induction of Remission in Patients with Ulcerative Colitis who Insufficiently Respond toother Mesalazine Formulations: A Japanese Single-center Study
Masaki Kato, Kohei Sugiyama, Maki Miyakawa, Masanao Nasuno, Hiroki Tanaka, Satoshi Motoya
Nippon Daicho Komonbyo Gakkai Zasshi.2021; 74(6): 357. CrossRef
pH‑dependent vs. constant release of mesalazine in the treatment of ulcerative colitis: Do drug delivery concepts determine therapeutic efficacy? (Review)
Helmut Deissler, Heinrich Krammer, Anton Gillessen
Biomedical Reports.2021;[Epub] CrossRef
Optimizing the Use of Current Treatments and Emerging Therapeutic Approaches to Achieve Therapeutic Success in Patients with Inflammatory Bowel Disease
Hiroshi Nakase
Gut and Liver.2020; 14(1): 7. CrossRef
Inflammatory Bowel Disease – Non-biological treatment
Fernando Magro, Gonçalo Cordeiro, Andreia Martins Dias, Maria Manuela Estevinho
Pharmacological Research.2020; 160: 105075. CrossRef
Systematic review: safety of mesalazine in ulcerative colitis
P. Sehgal, J.‐F. Colombel, A. Aboubakr, N. Narula
Alimentary Pharmacology & Therapeutics.2018; 47(12): 1597. CrossRef

9,569 View
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Comparison of efficacies of once-daily dose multimatrix mesalazine and multiple-dose mesalazine for the maintenance of remission in ulcerative colitis: a randomized, double-blind study: Haruhiko Ogata, Akihiro Ohori, Haruo Nishino, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi; Intest Res 2017;15(3):358-367. Published online June 12, 2017; DOI: https://doi.org/10.5217/ir.2017.15.3.358

Abstract PDF PubReader ePub

Background/Aims

This study compared the efficacy of once-daily administration of multimatrix mesalazine 2.4 g/day with multiple-dose mesalazine for the maintenance of remission.

Methods

In this multicenter, randomized, double-blind study, 203 patients with ulcerative colitis in remission received multimatrix mesalazine 2.4 g/day once-daily or time-dependent (controlled-release) mesalazine 2.25 g/day 3 times-daily for 48 weeks. The primary efficacy endpoint was the proportion of patients without rectal bleeding.

Results

The proportion of patients without rectal bleeding during the 48-week treatment period in the per protocol set was 84.8% (84/99) in the multimatrix mesalazine 2.4 g/day group and 78.0% (78/100) in the controlled-release mesalazine 2.25 g/day group. The difference between the 2 treatment groups was 6.8% (two-sided 95% confidence interval, −3.9% to 17.6%). The noninferiority margin of −10% was met in the comparison of multimatrix mesalazine 2.4 g/day once-daily with controlled-release mesalazine 2.25 g/day. Multimatrix mesalazine 2.4 g/day once-daily demonstrated consistent efficacy in all subgroups. There was no difference between the 2 treatment groups with regard to safety.

Conclusions

A once-daily dose of 2 multimatrix mesalazine tablets (2.4 g) was not inferior to controlled-release mesalazine 2.25 g/day 3 times-daily in maintaining absence of rectal bleeding in ulcerative colitis.

Citations

Citations to this article as recorded by

Long-Term Efficacy and Safety of Multi-Matrix Mesalazine Maintenance Therapy in Pediatric Patients with Ulcerative Colitis
Toshiaki Shimizu, Daisuke Tokuhara, Shigeo Nishimata, Takashi Ishige, Takahiro Kudo, Masahiro Takatsu, Kanako Nishimura, Akiko Matsuda, Koichi Hayashi, Katsuhiro Arai
Pediatric Gastroenterology, Hepatology & Nutrition.2026; 29(1): 44. CrossRef
Culture-based characterization of gut microbiota in inflammatory bowel disease
Hyunjoon Park, Soyoung Yeo, Taekyu Lee, Yumin Han, Chang Beom Ryu, Chul Sung Huh
Frontiers in Microbiology.2025;[Epub] CrossRef
A review on the current status and definitions of activity indices in inflammatory bowel disease: how to use indices for precise evaluation
Masahiro Kishi, Fumihito Hirai, Noritaka Takatsu, Takashi Hisabe, Yasumichi Takada, Tsuyoshi Beppu, Ken Takeuchi, Makoto Naganuma, Kazuo Ohtsuka, Kenji Watanabe, Takayuki Matsumoto, Motohiro Esaki, Kazutaka Koganei, Akira Sugita, Keisuke Hata, Kitarou Fut
Journal of Gastroenterology.2022; 57(4): 246. CrossRef
Inflammatory Bowel Disease – Non-biological treatment
Fernando Magro, Gonçalo Cordeiro, Andreia Martins Dias, Maria Manuela Estevinho
Pharmacological Research.2020; 160: 105075. CrossRef
Systematic review: safety of mesalazine in ulcerative colitis
P. Sehgal, J.‐F. Colombel, A. Aboubakr, N. Narula
Alimentary Pharmacology & Therapeutics.2018; 47(12): 1597. CrossRef
How to Optimally Use Currently Available Drugs in a Therapeutic Algorithm?
You Sun Kim
The Korean Journal of Gastroenterology.2018; 71(2): 74. CrossRef

7,720 View
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Pregnancy outcome in women with inflammatory bowel disease treated with anti-tumor necrosis factor and/or thiopurine therapy: a multicenter study from Japan: Shunsuke Komoto, Satoshi Motoya, Yuji Nishiwaki, Toshiyuki Matsui, Reiko Kunisaki, Katsuyoshi Matsuoka, Naoki Yoshimura, Takashi Kagaya, Makoto Naganuma, Nobuyuki Hida, Mamoru Watanabe, Toshifumi Hibi, Yasuo Suzuki, Soichiro Miura, Ryota Hokari; Intest Res 2016;14(2):139-145. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.139

Abstract PDF PubReader ePub

Background/Aims

Anti-tumor necrosis factor drugs (anti-TNF) and thiopurines are important treatment options in patients with inflammatory bowel disease (IBD), including during pregnancy. However, there are limited data on the benefit/risk profile of anti-TNF and thiopurines during pregnancy in Asia. The aim of this study was to analyze pregnancy outcomes of female Japanese IBD patients treated with anti-TNF and/or thiopurines.

Methods

This cross-sectional study assessed pregnancy outcomes in 72 women with IBD. Pregnancy outcomes were compared among 31 pregnancies without exposure to infliximab (IFX), adalimumab (ADA), or thiopurines; 24 pregnancies with exposure to anti-TNF treatment (23 IFX, 1 ADA); 7 pregnancies with exposure to thiopurines alone; and 10 pregnancies with exposure to both IFX and thiopurines.

Results

Thirty-five of the 41 pregnancies (85.3%) that were exposed to anti-TNF treatment and/or thiopurines resulted in live births after a median gestational period of 38 weeks. Of the 35 live births, 3 involved premature deliveries; 7, low birth weight; and 1, a congenital abnormality. There were 6 spontaneous abortions in pregnancies that were exposed to anti-TNF treatment (17.7%). Pregnancy outcomes among the 4 groups were similar, except for the rate of spontaneous abortions (P =0.037).

Conclusions

Exposure to anti-TNF treatment or thiopurines during pregnancy was not related to a higher incidence of adverse pregnancy outcomes in Japanese IBD patients except for spontaneous abortion.

Citations

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Ulcerative Colitis in Pregnancy: A Japanese Multicenter Cohort Study Focusing on Their Mutual Influence
Yuichi Shimodate, Akiko Shiotani, Ken-ichi Tarumi, Hiroshi Matsumoto, Osamu Handa, Noriaki Tomioka, Naoyuki Nishimura, Kazuhiro Matsueda, Hirokazu Mouri, Motowo Mizuno
Internal Medicine.2025; 64(11): 1633. CrossRef
North American clinical practice guidelines for the medical management of hidradenitis suppurativa in special patient populations
Raed Alhusayen, Serena Dienes, Megan Lam, Afsaneh Alavi, Ali Alikhan, Maria Aleshin, Emad Bahashwan, Steve Daveluy, Noah Goldfarb, Amit Garg, Wayne Gulliver, Tarannum Jaleel, Alexa B. Kimball, Mark G. Kirchhof, Joslyn Kirby, Joi Lenczowski, Hadar Lev-Tov,
Journal of the American Academy of Dermatology.2025; 92(4): 825. CrossRef
A retrospective study of neonatal and pregnancy outcomes in pregnant women suffering from inflammatory arthropathy treated with adalimumab
Navid Najarpour, Elham Rajaei, Karim Mowla, Alireza Ghanbaran
Revista Colombiana de Reumatología.2024; 31(3): 290. CrossRef
Anti-tumor necrosis factor-α therapy may not be safe during pregnancy in women with inflammatory bowel disease: an updated meta-analysis and systematic review
Wei Huang, Xinxing Zhang, Li Zhang, Xiaosong Dai, Heping Chen, Qin Xie
BMC Pregnancy and Childbirth.2024;[Epub] CrossRef
A retrospective study of neonatal and pregnancy outcomes in pregnant women suffering from inflammatory arthropathy treated with adalimumab
Navid Najarpour, Elham Rajaei, Karim Mowla, Alireza Ghanbaran
Revista Colombiana de Reumatología (English Edition).2024; 31(3): 290. CrossRef
The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef
Saudi consensus guidance for the management of inflammatory bowel disease during pregnancy
Nahla A. Azzam, Abdulelah Almutairdi, Hajer Y. Almudaiheem, Turki AlAmeel, Shakir A. Bakkari, Othman R. Alharbi, Khalidah A. Alenzi, Maha A. AlMolaiki, Bedor A. Al-Omari, Rayan G. Albarakati, Ahmed H. Al-Jedai, Omar I. Saadah, Majid A. Almadi, Badr Al-Baw
Saudi Journal of Gastroenterology.2023;[Epub] CrossRef
Biologics for Inflammatory Bowel Disease and Their Safety in Pregnancy: A Systematic Review and Meta-analysis
Ole Haagen Nielsen, John Mark Gubatan, Carsten Bogh Juhl, Sarah Elizabeth Streett, Cynthia Maxwell
Clinical Gastroenterology and Hepatology.2022; 20(1): 74. CrossRef
British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids
Mark D Russell, Mrinalini Dey, Julia Flint, Philippa Davie, Alexander Allen, Amy Crossley, Margreta Frishman, Mary Gayed, Kenneth Hodson, Munther Khamashta, Louise Moore, Sonia Panchal, Madeleine Piper, Clare Reid, Katherine Saxby, Karen Schreiber, Naz Se
Rheumatology.2022;[Epub] CrossRef
Association between Thiopurines Use and Pregnancy Outcomes in Female Patients with Inflammatory Bowel Disease: A Meta-Analysis
Yang Zhang, Dandan Li, Heng Guo, Weina Wang, Xingang Li, Su Shen
Current Pharmaceutical Design.2021; 27(19): 2317. CrossRef
Exposure to Infliximab During Pregnancy: Post-Marketing Experience
Anja Geldhof, Jennifer Slater, Michael Clark, Urmila Chandran, Danielle Coppola
Drug Safety.2020; 43(2): 147. CrossRef
The use of biological disease-modifying antirheumatic drugs for inflammatory arthritis in Korea: results of a Korean Expert Consensus
Eun-Jung Park, Hyungjin Kim, Seung Min Jung, Yoon-Kyoung Sung, Han Joo Baek, Jisoo Lee
The Korean Journal of Internal Medicine.2020; 35(1): 41. CrossRef
The Use of Biological Disease-modifying Antirheumatic Drugs for Inflammatory Arthritis in Korea: Results of a Korean Expert Consensus
Eun-Jung Park, Hyungjin Kim, Seung Min Jung, Yoon-Kyoung Sung, Han Joo Baek, Jisoo Lee
Journal of Rheumatic Diseases.2020; 27(1): 4. CrossRef
Maternal and neonatal outcomes associated with biologic exposure before and during pregnancy in women with inflammatory systemic diseases: a systematic review and meta-analysis of observational studies
Nicole W Tsao, Nevena Rebic, Larry D Lynd, Mary A De Vera
Rheumatology.2020; 59(8): 1808. CrossRef
Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review
N. Ghalandari, R. J. E. M. Dolhain, J. M. W. Hazes, E. P. van Puijenbroek, M. Kapur, H. J. M. J. Crijns
Drugs.2020; 80(16): 1699. CrossRef
Pregnancy and Neuromyelitis Optica Spectrum Disorder – Reciprocal Effects and Practical Recommendations: A Systematic Review
Rohan D'Souza, Danielle Wuebbolt, Katarina Andrejevic, Rizwana Ashraf, Vanessa Nguyen, Nusrat Zaffar, Dalia Rotstein, Ahraaz Wyne
Frontiers in Neurology.2020;[Epub] CrossRef
Relationship between the Clinical Course of Ulcerative Colitis during Pregnancy and the Outcomes of Pregnancy: A Retrospective Evaluation
Ayumi Ito, Bunei Iizuka, Teppei Omori, Shinichi Nakamura, Katsutoshi Tokushige
Internal Medicine.2018; 57(2): 159. CrossRef
The use of biologics and small molecules in pregnant patients with rheumatic diseases
Maria Gerosa, Lorenza Maria Argolini, Carolina Artusi, Cecilia Beatrice Chighizola
Expert Review of Clinical Pharmacology.2018; 11(10): 987. CrossRef
Long-term clinical outcome after infliximab discontinuation in patients with inflammatory bowel disease
Ji Min Lee, Yoon Jae Kim, Kang-Moon Lee, Hyuk Yoon, Bo-In Lee, Dae Bum Kim, Donghoon Kang
Scandinavian Journal of Gastroenterology.2018; 53(10-11): 1280. CrossRef
Impact of inflammatory bowel disease activity and thiopurine therapy on birth weight: A meta-analysis
Begoña Gonzalez-Suarez, Shreyashee Sengupta, Alan C Moss
World Journal of Gastroenterology.2017; 23(45): 8082. CrossRef
Maternal and fetal outcomes in pregnant Japanese women with inflammatory bowel disease: our experience with a series of 23 cases
Naoki Minami, Minoru Matsuura, Yorimitsu Koshikawa, Satoshi Yamada, Yusuke Honzawa, Shuji Yamamoto, Hiroshi Nakase
Intestinal Research.2017; 15(1): 90. CrossRef
Concerns in pregnancy and childbirth of women with inflammatory bowel disease
Sung-Ae Jung
Intestinal Research.2016; 14(2): 107. CrossRef
Common Adverse Effects of Anti-TNF Agents on Gestation
Zacharias Fasoulakis, Panagiotis Antsaklis, Nikolaos Galanopoulos, Emmanuel Kontomanolis
Obstetrics and Gynecology International.2016; 2016: 1. CrossRef

8,802 View
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23 Crossref

Efficacy and safety of two pH-dependent-release mesalamine doses in moderately active ulcerative colitis: a multicenter, randomized, double-blind, parallel-group study: Yasuo Suzuki, Mitsuo Iida, Hiroaki Ito, Isamu Saida, Toshifumi Hibi; Intest Res 2016;14(1):50-59. Published online January 26, 2016; DOI: https://doi.org/10.5217/ir.2016.14.1.50

Abstract PDF PubReader ePub

Background/Aims

The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC).

Methods

In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates.

Results

In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P>0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups.

Conclusions

The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9-10), benefit from higher doses of mesalamine compared to others.

Citations

Citations to this article as recorded by

Colitis and Crohn’s Foundation (India) consensus statements on use of 5-aminosalicylic acid in inflammatory bowel disease
Ajit Sood, Vineet Ahuja, Vandana Midha, Saroj Kant Sinha, C. Ganesh Pai, Saurabh Kedia, Varun Mehta, Sawan Bopanna, Philip Abraham, Rupa Banerjee, Shobna Bhatia, Karmabir Chakravartty, Sunil Dadhich, Devendra Desai, Manisha Dwivedi, Bhabhadev Goswami, Kir
Intestinal Research.2020; 18(4): 355. CrossRef
Nonimmunity against hepatitis B virus infection in patients newly diagnosed with inflammatory bowel disease
Seong Jae Yeo, Hyun Seok Lee, Byung Ik Jang, Eun Soo Kim, Seong Woo Jeon, Sung Kook Kim, Kyeong Ok Kim, Yoo Jin Lee, Hyun Jik Lee, Kyung Sik Park, Yun Jin Jung, Eun Young Kim, Chang Heon Yang
Intestinal Research.2018; 16(3): 400. CrossRef
Comparison of efficacy of multimatrix mesalazine 4.8 g/day once-daily with other high-dose mesalazine in active ulcerative colitis: a randomized, double-blind study
Haruhiko Ogata, Nobuo Aoyama, Seiichi Mizushima, Atsushi Hagino, Toshifumi Hibi
Intestinal Research.2017; 15(3): 368. CrossRef
Remission endpoints in ulcerative colitis: A systematic review
Maki Jitsumura, Rory Frederick Kokelaar, Dean Anthony Harris
World Journal of Meta-Analysis.2017; 5(4): 85. CrossRef
Potential Benefits of Dietary Fibre Intervention in Inflammatory Bowel Disease
Celestine Wong, Philip Harris, Lynnette Ferguson
International Journal of Molecular Sciences.2016; 17(6): 919. CrossRef
What is the real-life maintenance mesalazine dose in ulcerative colitis?
Alicia Algaba, Iván Guerra, Ana García García de Paredes, María Hernández Tejero, Carlos Ferre, Daniel Bonillo, Lara Aguilera, Antonio López-Sanromán, Fernando Bermejo
Revista Española de Enfermedades Digestivas.2016;[Epub] CrossRef

7,795 View
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Perspective

A new start for 'Intestinal Research' as an official journal of AOCC: Toshifumi Hibi; Intest Res 2016;14(1):1-1. Published online January 26, 2016; DOI: https://doi.org/10.5217/ir.2016.14.1.1

PDF PubReader ePub

4,853 View
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Review

Immunological Abnormalities in the Pathogenesis of Inflammatory Bowel Disease: Tadakazu Hisamatsu, Yohei Mikami, Katsuyoshi Matsuoka, Takanori Kanai, Toshifumi Hibi; Intest Res 2012;10(4):317-323. Published online October 31, 2012; DOI: https://doi.org/10.5217/ir.2012.10.4.317

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Crohn's disease and ulcerative colitis represent two distinct forms of inflammatory bowel diseases (IBD). In this paper, we discuss how immunological mechanisms contribute to the pathogenesis of IBD. Intestinal homeostasis is sustained by various kinds of cells, such as epithelial cells, lymphocytes, antigen presenting cells, and other innate immune cells. We pay special attention to intestinal CD14+ macrophages. Intestinal macrophages play a central role in the regulation of immune responses against commensal bacteria. In the physiological condition, intestinal macrophages lack the expression of innate-immune receptor CD14 and do not produce proinfl ammatory cytokines. We identified a unique macrophage subset of IBD in the human intestine, which expressed both macrophage (CD14, CD33, CD68) and dendritic cell (DC) markers (CD205, CD209) and produced larger amounts of proinflammatory cytokines, such as interleukin (IL)-23 and tumor necrosis factor (TNF)-Ձ. In addition, the CD14+ macrophages contributed to interferon (IFN)-Ճ production rather than IL-17 production by lamina propria mononuclear cells dependent on IL-23. We discuss herein this IL-23/IFN-Ճ-positive feedback loop in IBD patients. We also discuss IFN-Ճ and IL-17 production from mucosal T cells and natural killer (NK) cells. Here, we show our recent findings about the plasticity of T helper cells in colitis. Th 17 cells express T-bet, and finally lose the expression of retinoic acid-related orphan receptor (ROR)Ճt, the master regulator of Th 17 cells, and are differentiated 'alternative Th 1 cells.' In addition to Th 1 cells, mucosal NK cells are also important sources of IFN-Ճ. Some of our ideas may be provocative, but we hope this review paper will provide new and firm understanding of the pathogenesis of IBD. (Intest Res 2012;10:317-323)

Citations

Citations to this article as recorded by

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