Intestinal Research

Original Articles

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

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while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up.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

Citations to this article as recorded by

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

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Elisabetta Bretto, Davide Giuseppe Ribaldone, Gian Paolo Caviglia, Giorgio Maria Saracco, Elisabetta Bugianesi, Simone Frara
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Siyi Li, Chibuzo Sampson, Changhao Liu, Hai-long Piao, Hong-Xu Liu
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Quan Lu, Mei-feng Yang, Yu-jie Liang, Jing Xu, Hao-ming Xu, Yu-qiang Nie, Li-sheng Wang, Jun Yao, De-feng Li
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Jian Zeng, Zhong Wang, Xiao-Jun Yang
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Tackling Inflammatory Bowel Diseases: Targeting Proinflammatory Cytokines and Lymphocyte Homing
Yijie Song, Man Yuan, Yu Xu, Hongxi Xu
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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
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John Gubatan, Kian Keyashian, Samuel JS Rubin, Jenny Wang, Cyrus Buckman, Sidhartha Sinha
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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
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Subcutaneous integrin inhibitors may provide more treatment options for patients with moderate-to-severe ulcerative colitis
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7,839 View
204 Download
15 Web of Science
15 Crossref

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