Intestinal Research

Original Articles

IBD

Long-term clinical and real-world experience with Crohn’s disease treated with anti-tumor necrosis factor-α antibodies: Haruka Otake, Satohiro Matsumoto, Hirosato Mashima; Intest Res 2022;20(4):464-474. Published online March 31, 2022; DOI: https://doi.org/10.5217/ir.2021.00139

Background/Aims
Although anti-tumor necrosis factor (TNF)-α agents are important therapeutic drugs for Crohn’s disease (CD), data regarding their long-term sustained effects are limited. Herein, we evaluated the long-term loss of response (LOR) to anti-TNF-α agents in patients with CD.
Methods
This retrospective study included patients with CD who started treatment with infliximab or adalimumab as a first-line therapeutic approach. The cumulative event-free, retention, and surgery-free rates after the start of biological therapy were analyzed. Secondary LOR was analyzed in patients who achieved corticosteroid-free clinical remission after the start of biological therapy. Cox proportional hazards models were used to analyze the predictive factors of secondary LOR.
Results
The cumulative event-free rates at 1, 2, 5, and 10 years were 83.3%, 75.1%, 37.4%, and 23.3%, respectively. The incidence of LOR was 10.6% per patient-year of follow-up. At 12–14 weeks after the start of biological therapy, the proportion of patients with a C-reactive protein to albumin (CRP/ALB) ratio ≥0.18 was significantly higher in patients with LOR (P<0.001). Multivariate analysis indicates that a CRP/ALB ratio ≥0.18 (hazard ratio [HR], 5.86; 95% confidence interval [CI], 1.56–22.0; P=0.009) and upper gastrointestinal tract inflammation (HR, 3.00; 95% CI, 1.26–7.13; P=0.013) were predictive factors of secondary LOR.
Conclusions
Although anti-TNF-α agents contributed to long-term clinical remission of CD, the annual incidence of secondary LOR was 10.6%. The CRP/ALB ratio at 3 months after the start of biological therapy and upper gastrointestinal tract inflammation were identified as predictive factors of secondary LOR.

Citations

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Impact of age at diagnosis on long‐term prognosis in patients with intestinal Behçet's disease
Ji Young Chang, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Hee Cheon, Jihye Park
Journal of Gastroenterology and Hepatology.2024; 39(3): 519. CrossRef
Effectiveness and Tolerability of Methotrexate Combined with Biologics in Patients with Crohn’s Disease: A Multicenter Observational Study
Jihye Park, Jaeyoung Chun, Soo Jung Park, Jae Jun Park, Tae Il Kim, Hyuk Yoon, Jae Hee Cheon
Digestive Diseases and Sciences.2024; 69(3): 901. CrossRef
Developing a Machine-Learning Prediction Model for Infliximab Response in Crohn’s Disease: Integrating Clinical Characteristics and Longitudinal Laboratory Trends
Yun Qiu, Shixian Hu, Kang Chao, Lingjie Huang, Zicheng Huang, Ren Mao, Fengyuan Su, Chuhan Zhang, Xiaoqing Lin, Qian Cao, Xiang Gao, Minhu Chen
Inflammatory Bowel Diseases.2024;[Epub] CrossRef
Effectiveness of Switching to Subcutaneous Infliximab in Ulcerative Colitis Patients Experiencing Intravenous Infliximab Failure
June Hwa Bae, Jung-Bin Park, Ji Eun Baek, Seung Wook Hong, Sang Hyoung Park, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Sung Wook Hwang
Gut and Liver.2024; 18(4): 667. CrossRef
Comparative real-world outcomes between ustekinumab, infliximab, and adalimumab in bio-naïve and bio-experienced Crohn’s disease patients: a retrospective multicenter study
Ji Eun Na, Yong Eun Park, Jongha Park, Tae-Oh Kim, Jong Hoon Lee, Su Bum Park, Soyoung Kim, Seung Bum Lee
BMC Gastroenterology.2024;[Epub] CrossRef
Usefulness of Serum Leucine-rich Alpha 2 Glycoprotein in Crohn’s Disease: Is There Any Difference between Small Intestine and Colonic Lesions?
Satohiro Matsumoto, Hirosato Mashima
Crohn's & Colitis 360.2023;[Epub] CrossRef
Enrichment of Activated Fibroblasts as a Potential Biomarker for a Non-Durable Response to Anti-Tumor Necrosis Factor Therapy in Patients with Crohn’s Disease
Soo-Kyung Park, Gi-Young Lee, Sangsoo Kim, Chil-Woo Lee, Chang-Hwan Choi, Sang-Bum Kang, Tae-Oh Kim, Jaeyoung Chun, Jae-Myung Cha, Jong-Pil Im, Kwang-Sung Ahn, Seon-Young Kim, Min-Suk Kim, Chang-Kyun Lee, Dong-Il Park
International Journal of Molecular Sciences.2023; 24(19): 14799. CrossRef

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IBD

Incidence comparison of adverse events in patients with inflammatory bowel disease receiving different biologic agents: retrospective long-term evaluation: Brigida Barberio, Edoardo Vincenzo Savarino, Timothy Card, Cristina Canova, Francesco Baldisser, Alessandro Gubbiotti, Davide Massimi, Matteo Ghisa, Fabiana Zingone; Intest Res 2022;20(1):114-123. Published online August 4, 2021; DOI: https://doi.org/10.5217/ir.2021.00037

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Current literature is lacking in studies comparing the incidence of adverse events (AEs) in patients with inflammatory bowel diseases (IBD) treated with adalimumab (ADA) or vedolizumab (VDZ) in a real-life scenario. Therefore, our primary aim was to compare the AEs occurring in patients taking ADA to those of patients taking VDZ.
Methods
In this single center study, data on AEs from IBD patients who underwent treatment with ADA and VDZ were retrospectively collected. AE rates per 100 person-years were calculated. A Cox regression model was used to estimate the hazard ratios of the AEs between the 2 drugs.
Results
A total of 16 ADA patients (17.2%) and 11 VDZ patients (7.6%) had AEs causing drug interruption during the study period (P=0.02). Most of the AEs were noninfectious extraintestinal events (50% in ADA and 54.5% in VDZ) while infections accounted for 31.2% of the AEs in patients treated with ADA and 27.3% in those treated with VDZ. The incidence rate of AEs causing withdrawal of therapy was 13.2 per 100 person-years for ADA and 5.3 per 100 person-years for VDZ, corresponding to a 76% lower risk in patients in VDZ. Considering the first year of treatment, we observed 34 subjects treated with ADA (36.5%) having at least 1 AEs and 57 (39.3%) among those taking VDZ (P=0.67).
Conclusions
VDZ has a lower incidence rate of AEs causing withdrawal of treatment compared to ADA but a similar risk of AEs not causing drug interruption. Real-life head-to-head studies are still necessary to further explore the safety profile of these drugs.

Citations

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Impact of age at diagnosis on long‐term prognosis in patients with intestinal Behçet's disease
Ji Young Chang, Soo Jung Park, Jae Jun Park, Tae Il Kim, Jae Hee Cheon, Jihye Park
Journal of Gastroenterology and Hepatology.2024; 39(3): 519. CrossRef
Comparative Risk of Serious Infection With Vedolizumab vs Anti-Tumor Necrosis Factor in Inflammatory Bowel Disease: Results From Nationwide Swedish Registers
Sara Karlqvist, Michael C. Sachs, Carl Eriksson, Yang Cao, Scott Montgomery, Jonas F. Ludvigsson, Ola Olén, Jonas Halfvarson
American Journal of Gastroenterology.2024; 119(12): 2480. CrossRef
The effect of medical cannabis in inflammatory bowel disease: analysis from the UK Medical Cannabis Registry
Nishaanth Dalavaye, Simon Erridge, Martha Nicholas, Manaswini Pillai, Lara Bapir, Carl Holvey, Ross Coomber, James J Rucker, Jonathan Hoare, Mikael H Sodergren
Expert Review of Gastroenterology & Hepatology.2023; 17(1): 85. CrossRef
Infectious complications in patients with inflammatory bowel disease in Asia: the results of a multinational web-based survey in the 8th Asian Organization for Crohn’s and Colitis meeting
Yu Kyung Jun, Seong-Joon Koh, Dae Seong Myung, Sang Hyoung Park, Choon Jin Ooi, Ajit Sood, Jong Pil Im
Intestinal Research.2023; 21(3): 353. CrossRef
Beyond the survey, to the ideal therapy for Asian
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Which biologic agents increase perioperative complications in patients with inflammatory bowel disease?
Jihye Park
Intestinal Research.2022; 20(1): 1. CrossRef
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
Inflammatory Bowel Diseases.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
Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies
Cristina Rubín de Célix, María Chaparro, Javier P. Gisbert
Journal of Clinical Medicine.2022; 11(14): 4202. 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
Vedolizumab Is Safe and Efficacious for the Treatment of Pediatric-Onset Inflammatory Bowel Disease Patients Who Fail a Primary Biologic Agent
Sujin Choi, Eun Sil Kim, Yiyoung Kwon, Mi Jin Kim, Yon Ho Choe, Byung-Ho Choe, Ben Kang
Journal of Korean Medical Science.2022;[Epub] 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.

Citations

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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
Nippon Daicho Komonbyo Gakkai Zasshi.2024; 77(2): 89. CrossRef
Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
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
Intestinal Research.2023; 21(3): 406. CrossRef
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Julie J. Hong, Edward K. Hadeler, Megan L. Mosca, Nicholas D. Brownstone, Tina Bhutani, Wilson J. Liao
Journal of Psoriasis and Psoriatic Arthritis.2022; 7(2): 79. CrossRef
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Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician
Adam Saleh, Usman Ansari, Shaadi Abughazaleh, Kerri Glassner, Bincy P Abraham
Biologics: Targets and Therapy.2022; Volume 16: 67. CrossRef
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Jung-Bin Park, Sang Hyoung Park
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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
Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis
Juntao Yin, Yang Li, Yangyang Chen, Chaoyang Wang, Xiaoyong Song
European Journal of Medical Research.2022;[Epub] CrossRef
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef
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

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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.

Citations

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Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
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Real‐world experience of adalimumab therapy for patients with ulcerative colitis: A single tertiary medical center experience in Central Taiwan
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Pezhman Alavinejad, Sana Delavari, Abazar Parsi, Ali Akbar Shayesteh
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Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
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Suhyun Park, Sang Hyoung Park
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Byung Chul Jin, Hee Jin Moon, Sang Wook Kim
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Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
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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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Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia: Choon Jin Ooi, Ida Hilmi, Rupa Banerjee, Sai Wei Chuah, Siew Chien Ng, Shu Chen Wei, Govind K Makharia, Pises Pisespongsa, Min Hu Chen, Zhi Hua Ran, Byong Duk Ye, Dong Il Park, Khoon Lin Ling, David Ong, Vineet Ahuja, Khean Lee Goh, Jose Sollano, Wee Chian Lim, Wai Keung Leung, Raja Affendi Raja Ali, Deng Chyang Wu, Evan Ong, Nazri Mustaffa, Julajak Limsrivilai, Tadakazu Hisamatsu, Suk Kyun Yang, Qin Ouyang, Richard Geary, Janaka H De Silva, Rungsun Rerknimitr, Marcellus Simadibrata, Murdani Abdullah, Rupert WL Leong, the Asia Pacific Association of Gastroenterology (APAGE) Working Group on Inflammatory Bowel Disease and Asian Organization for Crohn’s and Colitis; Intest Res 2019;17(3):285-310. Published online May 31, 2019; DOI: https://doi.org/10.5217/ir.2019.00026

Abstract PDF PubReader ePub

The Asia-Pacific Working Group on inflammatory bowel disease (IBD) was established in Cebu, Philippines, under the auspices of the Asian Pacific Association of Gastroenterology with the goal of improving IBD care in Asia. This consensus is carried out in collaboration with Asian Organization for Crohn’s and Colitis. With biologic agents and biosimilars becoming more established, it is necessary to conduct a review on existing literature and establish a consensus on when and how to introduce biologic agents and biosimilars in the conjunction with conventional treatments for ulcerative colitis (UC) and Crohn’s disease (CD) in Asia. These statements also address how pharmacogenetics influence the treatments of UC and CD and provide guidance on response monitoring and strategies to restore loss of response. Finally, the review includes statements on how to manage treatment alongside possible hepatitis B and tuberculosis infections, both common in Asia. These statements have been prepared and voted upon by members of IBD workgroup employing the modified Delphi process. These statements do not intend to be all-encompassing and future revisions are likely as new data continue to emerge.

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Original Articles

IBD

Long-term prognosis of Japanese patients with biologic-naïve Crohn’s disease treated with anti-tumor necrosis factor-α antibodies: Rintaro Moroi, Katsuya Endo, Katsutoshi Yamamoto, Takeo Naito, Motoyuki Onodera, Masatake Kuroha, Yoshitake Kanazawa, Tomoya Kimura, Yoichi Kakuta, Atsushi Masamune, Yoshitaka Kinouchi, Tooru Shimosegawa; Intest Res 2019;17(1):94-106. Published online December 3, 2018; DOI: https://doi.org/10.5217/ir.2018.00048

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
Few reports have described the long-term treatment outcomes of the anti-tumor necrosis factor-α antibody for Japanese Crohn’s disease (CD) patients. The aim of this study was to evaluate them and clarify the clinical factors that affect the long-term prognosis of the anti-tumor necrosis factor-α treatments.
Methods
This was a retrospective, observational, single-center cohort study. Japanese CD patients treated with either infliximab or adalimumab as a first-line therapy were analyzed. The cumulative retention rates of the biologics, relapse-free survival, and surgery-free survival were analyzed using Kaplan-Meier methods. The clinical factors associated with the long-term outcomes were estimated by both the log-rank test and Cox proportional hazard model.
Results
The cumulative retention rate was significantly higher in the group with a concomitant elemental diet of ≥900 kcal/day, baseline C-reactive protein (CRP) levels <2.6 mg/dL, and baseline serum albumin levels ≥3.5 g/dL, respectively. The baseline serum albumin levels were also associated with both relapse-free and surgery-free survival. The lack of concomitant use of an elemental diet ≥900 kcal/day was identified as the only independent risk factor for the withdrawal of the biologics.
Conclusions
Baseline CRP levels and serum albumin levels could affect the long-term outcomes in CD patients. Concomitant elemental diet of ≥900 kcal/day could have a positive influence on clinical treatment course.

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Nutrition, Nutritional Status, Micronutrients Deficiency, and Disease Course of Inflammatory Bowel Disease
Marco Valvano, Annalisa Capannolo, Nicola Cesaro, Gianpiero Stefanelli, Stefano Fabiani, Sara Frassino, Sabrina Monaco, Marco Magistroni, Angelo Viscido, Giovanni Latella
Nutrients.2023; 15(17): 3824. CrossRef
Long-term clinical and real-world experience with Crohn’s disease treated with anti-tumor necrosis factor-α antibodies
Haruka Otake, Satohiro Matsumoto, Hirosato Mashima
Intestinal Research.2022; 20(4): 464. CrossRef
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
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Hyo Yeop Song, Geom Seog Seo
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Eun Ae Kang, Jung Won Park, Yehyun Park, Soo Jung Park, Tae Il Kim, Won Ho Kim, Min Soo Cho, Jae Hee Cheon
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Ji Young Chang, Jae Hee Cheon
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Fumihito Hirai, Teruyuki Takeda, Yasumichi Takada, Masahiro Kishi, Tsuyoshi Beppu, Noritaka Takatsu, Masaki Miyaoka, Takashi Hisabe, Kenshi Yao, Tosiharu Ueki
Journal of Gastroenterology.2020; 55(2): 133. CrossRef
TL1A (TNFSF15) genotype affects the long‐term therapeutic outcomes of anti‐TNFα antibodies for Crohn's disease patients
Katsuya Endo, Yoichi Kakuta, Rintaro Moroi, Katsutoshi Yamamoto, Hisashi Shiga, Masatake Kuroha, Takeo Naito, Yoshitaka Kinouchi, Atsushi Masamune
JGH Open.2020; 4(6): 1108. CrossRef

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IBD

Efficacy and safety of the adalimumab biosimilar Exemptia as induction therapy in moderate-to-severe ulcerative colitis: Vandana Midha, Ramit Mahajan, Varun Mehta, Vikram Narang, Arshdeep Singh, Kirandeep Kaur, Ajit Sood; Intest Res 2018;16(1):83-89. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.83

Abstract PDF PubReader ePub

Background/Aims

Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited.

Methods

Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response and remission were assessed at week 8 using Mayo score.

Results

A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years) with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%]; left-sided colitis in 20 patients [68.9%]) were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%), whereas clinical remission was observed only in 1 patient (3.5%). Among the non-responders (n=21), 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporine and tacrolimus, respectively. Four patients (13.8%) developed extrapulmonary tuberculosis.

Conclusions

The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.

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Ruma Rajbhandari, Samantha Blakemore, Neil Gupta, Sara Mannan, Klejda Nikolli, Alison Yih, Laura Drown, Gene Bukhman
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Nagesh Kamat, Saurabh Kedia, Uday C. Ghoshal, Abhimanyu Nehra, Govind Makharia, Ajit Sood, Vandana Midha, Varun Gupta, Gourdas Choudhuri, Vineet Ahuja
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Outcomes of limited period of adalimumab treatment in moderate to severe Crohn's disease patients: Taiwan Society of Inflammatory Bowel Disease Study: Wei-Chen Lin, Jen-Wei Chou, Hsu-Heng Yen, Wen-Hung Hsu, Hung-Hsin Lin, Jen-Kou Lin, Chiao-Hsiung Chuang, Tien-Yu Huang, Horng-Yuan Wang, Shu-Chen Wei, Jau-Min Wong; Intest Res 2017;15(4):487-494. Published online October 23, 2017; DOI: https://doi.org/10.5217/ir.2017.15.4.487

Abstract PDF PubReader ePub

Background/Aims

In Taiwan, due to budget limitations, the National Health Insurance only allows for a limited period of biologics use in treating moderate to severe Crohn's disease (CD). We aimed to access the outcomes of CD patients following a limited period use of biologics, specifically focusing on the relapse rate and remission duration; also the response rate to second use when applicable.

Methods

This was a multicenter, retrospective, observational study and we enrolled CD patients who had been treated with adalimumab (ADA) according to the insurance guidelines from 2009 to 2015.

Results

A total of 54 CD patients, with follow-up of more than 6 months after the withdrawal of ADA, were enrolled. The average period of treatment with ADA was 16.7±9.7 months. After discontinuing ADA, 59.3% patients suffered a clinical relapse. In the univariate analysis, the reason for withdrawal was a risk factor for relapse (P=0.042). In the multivariate analysis, current smoker became an important risk factor for relapse (OR, 3.9; 95% CI, 1.2−14.8; P=0.044) and male sex was another risk factor (OR, 2.9; 95% CI, 1.1−8.6; P=0.049). For those 48 patients who received a second round of biologics, the clinical response was seen in 60.4%, and 1 anaphylaxis occurred.

Conclusions

Fifty-nine percent of patients experienced a relapse after discontinuing the limited period of ADA treatment, and most of them occurred within 1 year following cessation. Male sex and current smoker were risk factors for relapse. Though 60.4% of the relapse patients responded to ADA again.

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Clinical efficacy of adalimumab versus infliximab and the factors associated with recurrence or aggravation during treatment of anal fistulas in Crohn's disease: Cheng-Chun Ji, Shota Takano; Intest Res 2017;15(2):182-186. Published online April 27, 2017; DOI: https://doi.org/10.5217/ir.2017.15.2.182

Abstract PDF PubReader ePub

Background/Aims

Infliximab has proven to be effective in the treatment of perianal fistulas in Crohn's disease (CD) but the efficacy of adalimumab is still unclear. The aim of this study is to assess the clinical efficacy of adalimumab and compare the results with those for infliximab.

Methods

Forty-seven CD patients treated for perianal fistulas with infliximab from September 2005 to December 2010 (n=31), or with adalimumab from November 2010 to May 2012 (n=16), were enrolled in this retrospective study. The following patient characteristics were analyzed; intestinal lesion site, fistula classification, seton placement, index of inflammatory bowel disease, C-reactive protein level, follow-up period, and the cumulative rate of nonrecurrence or aggravation of fistula.

Results

There were no significant differences in the intestinal lesion site, fistula classification, inflammatory bowel disease index, C-reactive protein level, and the frequency of injection between the infliximab group and the adalimumab group. The cumulative rate of nonrecurrence or aggravation of fistula was 62.5% in the adalimumab group and 83.9% in the infliximab group at 24 months after treatment (P=0.09). The risk factors for recurrence or aggravation may be related to seton placement (P=0.02), gender (P=0.06), and fistula classification (P=0.07).

Conclusions

There was no significant difference in the clinical efficacy of adalimumab and infliximab in the treatment of perianal fistulas in CD. However, fistula classification may be an important risk factor for recurrence or aggravation. The preliminary findings in this study show that further research is warranted.

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Choon Jin Ooi, Ida Hilmi, Rupa Banerjee, Sai Wei Chuah, Siew Chien Ng, Shu Chen Wei, Govind K Makharia, Pises Pisespongsa, Min Hu Chen, Zhi Hua Ran, Byong Duk Ye, Dong Il Park, Khoon Lin Ling, David Ong, Vineet Ahuja, Khean Lee Goh, Jose Sollano, Wee Chia
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Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia
Choon Jin Ooi, Ida Hilmi, Rupa Banerjee, Sai Wei Chuah, Siew Chien Ng, Shu Chen Wei, Govind K Makharia, Pises Pisespongsa, Min Hu Chen, Zhi Hua Ran, Byong Duk Ye, Dong Il Park, Khoon Lin Ling, David Ong, Vineet Ahuja, Khean Lee Goh, Jose Sollano, Wee Chia
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Long‐term outcomes of patients with Crohn's disease who received infliximab or adalimumab as the first‐line biologics
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Adalimumab or infliximab: which is better for perianal fistula in Crohn's disease?
Jong Pil Im
Intestinal Research.2017; 15(2): 147. CrossRef

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Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease: Kai-Chun Wu, Zhi Hua Ran, Xiang Gao, Minhu Chen, Jie Zhong, Jian-Qiu Sheng, Michael A Kamm, Simon Travis, Kori Wallace, Nael M Mostafa, Marisa Shapiro, Yao Li, Roopal B Thakkar, Anne M Robinson; Intest Res 2016;14(2):152-163. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.152

Abstract PDF Supplementary Material PubReader ePub

Background/Aims

This was a Phase 2 study (NCT02015793) to evaluate the pharmacokinetics, safety, and efficacy of adalimumab in Chinese patients with Crohn's disease (CD).

Methods

Thirty, adult Chinese patients with CD (CD Activity Index [CDAI] 220–450; high-sensitivity [hs]-C-reactive protein [CRP] ≥3 mg/L) received double-blind adalimumab 160/80 mg or 80/40 mg at weeks 0/2, followed by 40 mg at weeks 4 and 6. An open-label extension period occurred from weeks 8–26; patients received 40 mg adalimumab every other week. Serum adalimumab concentration and change from baseline in fecal calprotectin (FC) were measured during the double-blind period. Clinical remission (CDAI <150), response (decrease in CDAI ≥70 points from baseline), and change from baseline in hs-CRP were assessed through week 26. Nonresponder imputation was used for missing categorical data and last observation carried forward for missing hs-CRP/FC values. No formal hypothesis was tested. Adverse events were monitored.

Results

Mean adalimumab serum concentrations during the induction phase were 13.9–18.1 µg/mL (160/80 mg group) and 7.5−9.5 µg/mL (80/40 mg group). During the double-blind period, higher remission/response rates and greater reductions from baseline in hs-CRP and FC were observed with adalimumab 160/80 mg compared to that with 80/40 mg. Adverse event rates were similar among all treatment groups.

Conclusions

Adalimumab serum concentrations in Chinese patients with CD were comparable to those observed previously in Western and Japanese patients. Clinically meaningful remission rates and improvement in inflammatory markers were achieved with both dosing regimens; changes occurred rapidly with adalimumab 160/80 mg induction therapy. No new safety signals were reported.

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Sisi Zhou, Zeyu Huang, Wenjing Hou, Yiting Lin, Jing Yu
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Seronegative spondyloarthropathy-associated inflammatory bowel disease
Chrong-Reen Wang, Hung-Wen Tsai
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Chenthan Krishnakumar, Ashwin N. Ananthakrishnan, Brendan M. Boyle, Anne M. Griffiths, Neal S. LeLeiko, David R. Mack, James F. Markowitz, Joel R. Rosh, Cary G. Sauer, Thomas D. Walters, Erin Bonkowski, Lee A. Denson, Jeffrey S. Hyams, Subra Kugathasan
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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
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Yong Eun Park, Jae Hee Cheon
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Jong Pil Im, Byong Duk Ye, You Sun Kim, Joo Sung Kim
The Korean Journal of Internal Medicine.2018; 33(1): 28. CrossRef
Long-Term Outcomes of Adalimumab Treatment in 254 Patients with Crohn’s Disease: A Hospital-Based Cohort Study from Korea
Hyungil Seo, Byong Duk Ye, Eun Mi Song, Sun-Ho Lee, Kiju Chang, Ho-Su Lee, Sung Wook Hwang, Sang Hyoung Park, Dong-Hoon Yang, Kyung-Jo Kim, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang
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Scientific Reports.2017;[Epub] CrossRef

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Clinical features of active tuberculosis that developed during anti-tumor necrosis factor therapy in patients with inflammatory bowel disease: Jang Wook Lee, Chang Hwan Choi, Ji Hoon Park, Jeong Wook Kim, Sang Bum Kang, Ja Seol Koo, Young-Ho Kim, You Sun Kim, Young Eun Joo, Sae Kyung Chang; Intest Res 2016;14(2):146-151. Published online April 27, 2016; DOI: https://doi.org/10.5217/ir.2016.14.2.146

Abstract PDF PubReader ePub

Background/Aims

Anti-tumor necrosis factor (TNF) therapy for active ulcerative colitis (UC) and Crohn's disease (CD) is associated with increased risks of tuberculosis (TB) infection. We analyzed the incidence and clinical features of Korean patients with inflammatory bowel disease (IBD) who developed active TB during anti-TNF therapy.

Methods

Ten cases of active TB developed in patients treated with infliximab (n=592) or adalimumab (n=229) for UC (n=160) or CD (n=661) were reviewed. We analyzed demographics, interval between start of anti-TNF therapy and active TB development, tests for latent TB infection (LTBI), concomitant medications, and the details of diagnosis and treatments for TB.

Results

The incidence of active TB was 1.2% (10/821): 1.5% (9/592) and 0.4% (1/229) in patients receiving infliximab and adalimumab, respectively. The median time to the development of active TB after initiation of anti-TNF therapy was three months (range: 2–36). Three patients had past histories of treatment for TB. Positive findings in a TB skin test (TST) and/or interferon gamma releasing assay (IGRA) were observed in three patients, and two of them received anti-TB prophylaxis. Two patients were negative by both TST and IGRA. The most common site of active TB was the lungs, and the active TB was cured in all patients.

Conclusions

Active TB can develop during anti-TNF therapy in IBD patients without LTBI, and even in those with histories of TB treatment or LTBI prophylaxis. Physicians should be aware of the potential for TB development during anti-TNF therapy, especially in countries with a high prevalence of TB.

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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
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, Yasu
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Case Report

Usefulness of Adalimumab for Treating a Case of Intestinal Behçet's Disease With Trisomy 8 Myelodysplastic Syndrome: Masamichi Kimura, Yoshihisa Tsuji, Masako Iwai, Masahiro Inagaki, Ali Madian, Takuya Yoshino, Minoru Matsuura, Hiroshi Nakase; Intest Res 2015;13(2):166-169. Published online April 27, 2015; DOI: https://doi.org/10.5217/ir.2015.13.2.166

Abstract PDF PubReader

Behçet's disease (BD) is a systemic vasculitis, while myelodysplastic syndrome (MDS) is a heterogeneous group of clonal hematologic disorders characterized by ineffective hematopoiesis. Some studies suggest a relationship between MDS and BD, especially intestinal BD, and trisomy 8 seems to play an important role in both diseases. There are several reports on patients with BD comorbid with MDS involving trisomy 8 that frequently have intestinal lesions refractory to conventional medical therapies. Tumor necrosis factor (TNF)-α is strongly involved in the pathophysiology of several autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease, and BD. In addition, TNF-α plays an important role in the pathophysiology of MDS by inhibiting normal hematopoiesis and inducing the programmed cell death of normal total bone marrow cells and normal CD34+ cells. Recent clinical reports demonstrate the favorable effect of TNF-α antagonists in patients with refractory intestinal BD and in those with MDS. We present the case of a patient with intestinal BD and MDS involving trisomy 8 who was successfully treated with adalimumab.

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Original Article

Safety and Efficacy of Adalimumab for Patients With Moderate to Severe Crohn's Disease: The Taiwan Society of Inflammatory Bowel Disease (TSIBD) Study: Chen-Wang Chang, Shu-Chen Wei, Jen-Wei Chou, Tzu-Chi Hsu, Chiao-Hsiung Chuang, Ching-Pin Lin, Wen-Hung Hsu, Hsu-Heng Yen, Jen-Kou Lin, Yi-Jen Fang, Horng-Yuan Wang, Hung-Hsin Lin, Deng Cheng Wu, Yen Hsuan Ni, Cheng-Yi Wang, Jau-Min Wong; Intest Res 2014;12(4):287-292. Published online October 27, 2014; DOI: https://doi.org/10.5217/ir.2014.12.4.287

Abstract PDF PubReader ePub

Background/Aims

Only moderate to severe Crohn's Disease (CD) patients without a satisfactory conventional therapy effect are eligible to get reimbursement from the National Health Insurance of Taiwan for using adalimumab. These are more stringent criteria than in many Western countries and Japan and Korea. We aim to explore the efficacy of using adalimumab in CD patients under such stringent criteria.

Methods

A retrospective analysis was conducted in nine medical centers in Taiwan and we collected the results of CD patients receiving adalimumab from Sep 2009 to Mar 2014. The clinical characteristics, response measured by CDAI (Crohn's Disease Activity Index), adverse events and survival status were recorded and analyzed. CR-70, CR-100, and CR-150 were defined as attaining a CDAI decrease of 70, 100 or 150 points compared with baseline.

Results

A total of 103 CD patient records were used in this study. Sixty percent of these patients received combination therapy of adalimumab together with immunomodulators. CR-70 was 68.7%, 74.5% and 88.4% after week 4, 8 and 12 of treatment, respectively. The steroid-free rate, complications and survival were 47.6%, 9.7% and 99% of patients, respectively. In considering the mucosal healing, only 25% patients achieve mucosal healing after treatment for 6 to 12 months. Surgery was still needed in 16.5% of patients. Combination treatment of adalimumab with immunomodulators further decreased the level of CDAI at week 8 when compared with the monotherapy.

Conclusions

Even under the stringent criteria for using adalimumab, the response rate was comparable to those without stringent criteria.

Citations

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Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents
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Hsu‐Heng Yen, Yu‐Chun Hsu, Chu‐Hsuan Kuo, Tsui‐Chun Hsu, Yang‐Yuan Chen
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Hsu-Heng Yen, Tsui-Chun Hsu, Mei-Wen Chen, Pei-Yuan Su, Yang-Yuan Chen
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Administration Timing Is the Best Clinical Outcome Predictor for Adalimumab Administration in Crohn's Disease
Mauro Mastronardi, Margherita Curlo, Elisabetta Cavalcanti, Osvaldo Burattini, Renato Cuppone, Romina Tauro, Stefania De Santis, Grazia Serino, Pasqua Letizia Pesole, Elisa Stasi, Maria Lucia Caruso, Rossella Donghia, Vito Guerra, Pietro Giorgio, Marcello
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