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Efficacy and safety of biosimilar versus originator infliximab in patients with inflammatory bowel disease: A real-world cohort analysis

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Abstract

Background

Anti-tumor necrosis factor (anti-TNF) monoclonal antibody, infliximab, is the primary therapeutic modality for patients with Crohn’s disease (CD) and ulcerative colitis (UC), refractory to conventional therapy. Biosimilars of infliximab have been shown to have equivalent efficacy to originator infliximab. We compared the safety and efficacy of infliximab biosimilar with the originator in Indian patients with inflammatory bowel disease (IBD).

Methods

Patients with IBD treated with either originator or biosimilar infliximab from January 2005 to October 2020 were included in this retrospective analysis. The safety and efficacy of originator or biosimilar infliximab in inducing and maintaining clinical remission at weeks 14 and 52 for CD and UC were evaluated. Disease activity was estimated at baseline, after induction therapy, after 1 year of treatment, and during 12 months of follow-up.

Results

In all, 137 patients (82 CD; 55 UC) were included, of whom 102 were on originator, and 35 patients received biosimilar. In biosimilar group, clinical response and remission rates at weeks 14 and 52 were 84.2%, 58% and 68.4%, 52.6% in CD and 81.2%, 56.2% and 68.7%, 62.5% in UC patients, respectively. Among patients who were on originator, clinical response and remission rates at weeks 14 and 52 were 79.4%, 46% and 57.1%, 43% in CD and 72%, 64.1% and 66.7%, 56.4% in UC patients, respectively. Thirty-three (24.1%) patients experienced adverse events; eighteen developed tuberculosis (TB), of whom 17 received originator and one patient received biosimilar.

Conclusions

Infliximab biosimilar is comparable to originator infliximab in terms of safety profile and its efficacy in inducing and maintaining remission in patients with IBD.

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Funding

Indian Council for Medical Research - Centre for Advanced Research and Excellence in Intestinal Diseases.

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Authors and Affiliations

  1. Department of Gastroenterology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110 029, India

    Peeyush Kumar, Sudheer K. Vuyyuru, Bhaskar Kante, Saurabh Kedia, Pabitra Sahu, Mukesh Kumar Ranjan, Sandeep Mundhra, Rithvik Golla, Mukesh Kumar, Shubi Virmani, Anvita Gupta, Nidhi Yadav, Govind Makharia & Vineet Ahuja

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  1. Peeyush Kumar
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Correspondence to Vineet Ahuja.

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Conflict of interest

PK, SKV, BK, SK, PS, MKR, SM, RG, MK, SV, AG, NY, GM, and VA declare no competing interests.

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The study was performed conforming to the Helsinki declaration of 1975, as revised in 2000 and 2008 concerning human and animal rights, and the authors followed the policy concerning informed consent as shown on Springer.com.

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Kumar, P., Vuyyuru, S.K., Kante, B. et al. Efficacy and safety of biosimilar versus originator infliximab in patients with inflammatory bowel disease: A real-world cohort analysis. Indian J Gastroenterol 41, 446–455 (2022). https://doi.org/10.1007/s12664-022-01252-5

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