Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea

Abstract

Objective: To evaluate the safety and efficacy of CT-P13 (Remsima^®) in patients with inflammatory bowel disease (IBD) in South Korea. Methods: This post-marketing study included patients with active moderate-to-severe Crohn’s disease (CD), fistulizing CD (FCD), or moderate-to-severe ulcerative colitis (UC) treated with CT-P13 and followed for 30 weeks. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission. Results: No unexpected TEAEs were observed in the 173 patients recruited to date. TEAEs occurred in 18.1, 16.7, and 26.9% of CD, FCD, and UC patients, respectively. Treatment-related TEAEs occurred in 10% of patients and were mostly mild-moderate in severity. There were five serious TEAEs (two infusion-related reactions, two infections, one abdominal pain) and no cases of malignancy, pneumonia, or death. Positive outcomes for response/remission were reported regardless of whether patients had received prior infliximab or not. Conclusion: CT-P13 was well tolerated and efficacious in patients with IBD.

Keywords:

• biosimilar
• Crohn’s disease
• CT-P13
• efficacy
• inflammatory bowel disease
• infliximab
• post-marketing study
• safety
• South Korea
• switching
• ulcerative colitis

Financial & competing interests disclosure

The study was sponsored by Celltrion. Y Kim, JH Lee, HJ Kwon, S Lee, D Park, HK Kim, JH Cheon, JP Im, and YS Kim have all received financial support for research from Celltrion, Inc., SY Lee and SJ Lee are employees of Celltrion Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Editorial support (writing assistance, assembling tables and figures, collating author comments, grammatical editing, and referencing) was provided by Mark O’Connor (Aspire Scientific Limited, Bollington, UK) and was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea).

Key issues

• CT-P13 is a biosimilar of infliximab approved in Europe for the same indications as infliximab RMP, including IBD following extrapolation of comparability data from rheumatic diseases.

• Because use of biosimilars in the treatment of IBD is a focus of scientific attention, additional clinical studies and PMS can play a crucial part in facilitating appropriate use of such new therapies based on better understanding of benefits and risks.

• To provide further data on the efficacy and safety of CT-P13 in routine care, a postmarketing clinical study of CT-P13 is being conducted in Korea in patients with IBD; safety data for 173 patients are reported.

• The current PMS demonstrated that CT-P13 is well tolerated and efficacious in patients with IBD. Overall, these findings reinforce the clinical similarity between CT-P13 and RMP in patients with IBD.

Notes