Intestinal Research

Original Articles

Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease: Ryohei Nomaru, Teruyuki Takeda, Atsushi Takahashi, Hiroyuki Mikumo, Shigeyoshi Yasukawa, Akihiro Koga, Takao Kanemitsu, Yoichiro Ono, Noritaka Takatsu, Masaki Miyaoka, Takashi Hisabe, Hisatomi Arima, So Imakiire, Eri Yamauchi, Shinya Ashizuka, Fumihito Hirai; Received June 30, 2025 Accepted September 4, 2025 Published online November 27, 2025; DOI: https://doi.org/10.5217/ir.2025.00118 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
The introduction of anti-tumor necrosis factor-α antibodies transformed the landscape of inflammatory bowel disease (IBD) treatment. Because biologics are associated with increased medical costs, the use of biosimilars (BS) is recommended. However, high-quality evidence on the efficacy of BS in Japan remains limited. Therefore, this study aimed to evaluate the efficacy and safety of BS in patients with IBD.
Methods
Patients with IBD who underwent a non-medical switch (NMS) from infliximab originator (IFX-O) to IFX-BS at Fukuoka University Chikushi Hospital were prospectively evaluated. The observation period was up to 56 weeks after the NMS, and the rate of continuation, clinical remission at 56 weeks, safety, and changes in trough concentration were analyzed. Moreover, a questionnaire survey regarding BS and NMS was conducted.
Results
A total of 167 patients were included in this study. The continuation rate for IFX-BS therapy after NMS was high (95.6%). The remission maintenance rate at 56 weeks was 85.7% for patients with Crohn’s disease and 77.8% for patients with ulcerative colitis. Adverse events were observed in 22.8% of patients. However, only 2 severe adverse events were recorded. The ratios of trough concentrations at 8, 24, and 56 weeks to that at week 0 were 115.6%, 101.2%, and 123.5%, respectively, indicating statistical non-inferiority. In a questionnaire survey, only 6.2% of the patients were aware of BS, however, more than half of them agreed with the NMS recommendation.
Conclusions
The efficacy and safety of IFX-BS after NMS are high. In addition, its trough concentration is serologically non-inferior to baseline values.

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IBD

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.

Citations

Citations to this article as recorded by

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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Miscellaneous

Risk factors for severity of colonic diverticular hemorrhage: Ken Kinjo, Toshiyuki Matsui, Takashi Hisabe, Hiroshi Ishihara, Toshiki Kojima, Kenta Chuman, Shigeyoshi Yasukawa, Tsuyoshi Beppu, Akihiro Koga, Satoshi Ishikawa, Masahiro Kishi, Noritaka Takatsu, Fumihito Hirai, Kenshi Yao, Toshiharu Ueki, Masakazu Washio; Intest Res 2018;16(3):458-466. Published online July 27, 2018; DOI: https://doi.org/10.5217/ir.2018.16.3.458

Abstract PDF PubReader ePub

Background/Aims

Colonic diverticular hemorrhage (DH) was a rare disease until the 1990s, and its incidence has increased rapidly since 2000 in Japan. In recent years, colonic DH has been the most frequent cause of lower gastrointestinal bleeding (LGIB). Nearly all cases of DH are mild, with the bleeding often stopping spontaneously. Some cases, however, require surgery or arterial embolization. In this study, using a cohort at Fukuoka University Chikushi Hospital, we investigated factors associated with severe colonic DH.

Methods

Among patients with LGIB who underwent colonoscopy at our hospital between 1995 and 2013, DH was identified in 273 patients. Among them, 62 patients (22.7%) were defined as having severe colonic DH according to recurrence of bleeding in a short period, and/or the necessity of transfusion, arterial embolization, or surgery. We then evaluated risk factors for severe DH among DH patients in this retrospective cohort.

Results

Among the 273 patients with DH, use of non-steroidal anti-inflammatory drugs (NSAIDs) (odds ratio [OR], 2.801; 95% confidence interval [CI], 1.164–6.742), Charlson Risk Index (CRI) ≥2 (OR, 3.336; 95% CI, 1.154–7.353), right-sided colonic DH (OR, 3.873; 95% CI, 1.554–9.653), and symptoms of cerebral hypoperfusion (such as light-headedness, dizziness, or syncope) (OR, 2.926; 95% CI, 1.310–6.535) showed an increased risk of severe DH even after controlling for other factors.

Conclusions

Severe DH occurred in 23% of DH patients, and NSAID use, CRI ≥2, right-sided colonic DH, and symptoms of cerebral hypoperfusion are suggested to be predictors of severe DH.

Citations

Citations to this article as recorded by

Management of Colonic Diverticular Disease in the Older Adult
Hiep S. Phan, Lisa L. Strate
Current Gastroenterology Reports.2025;[Epub] CrossRef
Clinical Factors Associated with Severity of Colonic Diverticular Bleeding and Impact of Bleeding Site
Hirohito Amano, Takatsugu Yamamoto, Ken Ikusaka, Naoaki Aoki, Miyoko Sakurai, Taku Honda, Kyohei Maruyama, Hitoshi Aoyagi, Akari Isono, Koichiro Abe, Yoshinari Asaoka, Shinya Kodashima, Atsushi Tanaka
Journal of Clinical Medicine.2023; 12(5): 1826. CrossRef
Effectiveness and Safety of Endoscopic Submucosal Dissection for Colorectal Neoplasm in Patients with High Charlson Comorbidity Index Score: A HASID Multicenter Study
Dong-Hyun Kim, Yong-Wook Jung, Byung-Chul Jin, Hyung-Hoon Oh, Hyo-Yeop Song, Seong-Jung Kim, Dae-Seong Myung, Sang-Wook Kim, Jun Lee, Geom-Seog Seo, Young-Eun Joo, Hyun-Soo Kim
Journal of Clinical Medicine.2023; 12(19): 6255. CrossRef
Risk factors for patients hospitalized with recurrent colon diverticular bleeding: a single center experience
Hye-Su You, Dong Hyun Kim, Seo-Yeon Cho, Seon-Young Park, Chang Hwan Park, Hyun-Soo Kim, Sung Kyu Choi
Frontiers in Medicine.2023;[Epub] CrossRef
Construction of a Model for Predicting the Severity of Diverticular Bleeding in an Elderly Population
Tomoyuki Okada, Tsuyoshi Mikamo, Ayana Nakashima, Atsushi Yanagitani, Kiwamu Tanaka, Hajime Isomoto
Internal Medicine.2022; 61(15): 2247. CrossRef
Diagnosis and Treatment of Colonic Diverticular Disease
You Sun Kim
The Korean Journal of Gastroenterology.2022; 79(6): 233. CrossRef
Development and Validation of Predictive Assessment of Complicated Diverticulitis Score
Marcello Covino, Valerio Papa, Antonio Tursi, Benedetta Simeoni, Loris Riccardo Lopetuso, Lorenzo Maria Vetrone, Francesco Franceschi, Gianludovico Rapaccini, Antonio Gasbarrini, Alfredo Papa
Journal of Personalized Medicine.2021; 11(2): 80. CrossRef
Risk of Rebleeding in Patients with Small Bowel Vascular Lesions
Akira Harada, Takehiro Torisu, Shin Fujioka, Yuichiro Yoshida, Yasuharu Okamoto, Yuta Fuyuno, Atsushi Hirano, Junji Umeno, Kumiko Torisu, Tomohiko Moriyama, Motohiro Esaki, Takanari Kitazono
Internal Medicine.2021; 60(23): 3663. CrossRef
Vegetarianism as a protective factor for asymptomatic colonic diverticulosis in Asians: a retrospective cross-sectional and case-control study
Jihun Bong, Hyoun Woo Kang, Hyeki Cho, Ji Hyung Nam, Dong Kee Jang, Jae Hak Kim, Jun Kyu Lee, Yun Jeong Lim, Moon-Soo Koh, Jin Ho Lee
Intestinal Research.2020; 18(1): 121. CrossRef

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IBD

Trough level of infliximab is useful for assessing mucosal healing in Crohn's disease: a prospective cohort study: Akihiro Koga, Toshiyuki Matsui, Noritaka Takatsu, Yasumichi Takada, Masahiro Kishi, Yutaka Yano, Takahiro Beppu, Yoichiro Ono, Kazeo Ninomiya, Fumihito Hirai, Takashi Nagahama, Takashi Hisabe, Yasuhiro Takaki, Kenshi Yao, Hirotsugu Imaeda, Akira Andoh; Intest Res 2018;16(2):223-232. Published online April 30, 2018; DOI: https://doi.org/10.5217/ir.2018.16.2.223

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

Decreased trough levels of infliximab (TLI) and antibodies to infliximab (ATI) are associated with loss of response (LOR) in Crohn's disease. Two prospective studies were conducted to determine whether TLI or ATI better correlates with LOR (Study 1), and whether TLI could become a predictor of mucosal healing (MH) (Study 2).

Methods

Study 1 was conducted in 108 patients, including those with LOR and remission to compare ATI and TLI in discriminating the 2 conditions based on receiver operating characteristic (ROC) curve analyses. Study 2 involved 35 patients who were evaluated endoscopically.

Results

In Study 1, there were no differences between the 2 assays in ROC curve analyses; the TLI cutoff value for LOR was 2.6 µg/mL (sensitivity, 70.9%; specificity, 79.2%), and the ATI cutoff value was 4.9 µg/mL (sensitivity, 65.5%; specificity, 67.9%). The AUROC (area under the ROC curve) of TLI was greater than that of ATI. AUROC was useful for discriminating between the 2 conditions. In Study 2, the TLI was significantly higher in the colonic MH group than in the non-MH group (2.7 µg/mL vs. 0.5 µg/mL, P=0.032).

Conclusions

TLI is better than ATI for clinically diagnosing LOR, and a correlation was observed between TLI and colonic MH.

Citations

Citations to this article as recorded by

Mucosal and Transmural Healing and Long-term Outcomes in Crohn’s Disease
Bruce E Sands, Silvio Danese, J Casey Chapman, Khushboo Gurjar, Stacy Grieve, Deepika Thakur, Jenny Griffith, Namita Joshi, Kristina Kligys, Axel Dignass
Inflammatory Bowel Diseases.2025; 31(3): 857. CrossRef
Is infliximab therapy currently relevant in patients with inflammatory bowel diseases? (review)
T. L. Alexandrov, B. A. Vykova
Koloproktologia.2024; 23(2): 173. CrossRef
Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study
Mayte Buchbender, Jakob Fehlhofer, Peter Proff, Tobias Möst, Jutta Ries, Matthias Hannig, Markus F. Neurath, Madline Gund, Raja Atreya, Marco Kesting
Clinical Oral Investigations.2022; 26(2): 1217. CrossRef
Microbiota and Drug Response in Inflammatory Bowel Disease
Martina Franzin, Katja Stefančič, Marianna Lucafò, Giuliana Decorti, Gabriele Stocco
Pathogens.2021; 10(2): 211. CrossRef
Post-Induction High Adalimumab Drug Levels Predict Biological Remission at Week 24 in Patients With Crohn's Disease
Eran Zittan, A. Hillary Steinhart, Pavel Goldstein, Raquel Milgrom, Ian M. Gralnek, Mark S. Silverberg
Clinical and Translational Gastroenterology.2021; 12(10): e00401. CrossRef
Potential Utility of Therapeutic Drug Monitoring of Adalimumab in Predicting Short-Term Mucosal Healing and Histologic Remission in Pediatric Crohn's Disease Patients
So Yoon Choi, Young Ok Choi, Yon Ho Choe, Ben Kang
Journal of Korean Medical Science.2020;[Epub] CrossRef
Clinical and laboratory markers associated with anti-TNF-alpha trough levels and anti-drug antibodies in patients with inflammatory bowel diseases
Ana B. Grinman, Maria das Graças C. de Souza, Eliete Bouskela, Ana Teresa P. Carvalho, Heitor S. P. de Souza
Medicine.2020; 99(10): e19359. CrossRef
Changes in the Intestinal Microbiota of Patients with Inflammatory Bowel Disease with Clinical Remission during an 8-Week Infliximab Infusion Cycle
Gyeol Seong, Namil Kim, Je-Gun Joung, Eun Ran Kim, Dong Kyung Chang, Jongsik Chun, Sung Noh Hong, Young-Ho Kim
Microorganisms.2020; 8(6): 874. CrossRef
Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events
Mitchell R. K. L. Lie, Emma Paulides, C. Janneke van der Woude
International Journal of Colorectal Disease.2020; 35(8): 1489. CrossRef
Association of Infliximab Levels With Mucosal Healing Is Time-Dependent in Crohn’s Disease: Higher Drug Exposure Is Required Postinduction Than During Maintenance Treatment
Ting Feng, Baili Chen, Bella Ungar, Yun Qiu, Shenghong Zhang, Jinshen He, Sinan Lin, Yao He, Zhirong Zeng, Shomron Ben-Horin, Minhu Chen, Ren Mao
Inflammatory Bowel Diseases.2019; 25(11): 1813. CrossRef
Mucosal healing in inflammatory bowel disease: Expanding horizon
Jimil Shah, Manik Lal Thakur, Usha Dutta
Indian Journal of Gastroenterology.2019; 38(2): 98. CrossRef

9,412 View
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10 Web of Science
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