A real-world, observational, prospective cohort study evaluating the safety and effectiveness of CT-P13 in inflammatory bowel disease and rheumatoid arthritis: the MEGA-J study
Creators: name: Ishida, Tetsuya
name: Yokoe, Isamu
name: Obata, Hirozumi
name: Park, Soyeon
name: Kim, SooKyoung
name: Nishimata, Nobuaki
Publisher: name: Taylor & Francis
Year: 2025
Subjects: subject: Medicine
subject: Biotechnology
subject: Environmental Sciences not elsewhere classified
subject: Chemical Sciences not elsewhere classified
subject: Ecology
subject: FOS: Biological sciences
subject: Immunology
subject: FOS: Clinical medicine
subject: Science Policy

description: The primary objective of the MEGA-J study (UMIN-CTR number: UMIN000057308) was to assess the safety of CT-P13, an infliximab biosimilar, in Japanese patients with Crohn’s disease (CD), ulcerative colitis (UC), and/or rheumatoid arthritis (RA) after switching from reference infliximab. Data were collected over 5 years, following initiation of CT-P13 treatment within routine clinical practice. Interim findings are reported (cut-off: last patient’s Year 2 visit). The primary endpoint was the incidence of uncommon adverse drug reactions (ADRs), including tuberculosis and serious infections. Overall, 220 patients were enrolled (123 CD; 74 UC; 23 RA). Forty-eight (39.0%), 37 (50.0%), and 3 (13.0%) patients reported ≥1 uncommon ADR in the CD, UC, and RA groups, respectively. The majority (94.3%) were unrelated to CT-P13. No cases of tuberculosis and one unrelated case of serious infection were reported. Nineteen (8.6%) patients discontinued treatment for reasons related to CT-P13. Overall, CT-P13 was well tolerated, demonstrating the safety of long-term treatment in real-world practice. Immune-mediated inflammatory diseases (IMIDs) are conditions that cause chronic inflammation in various tissues and organs, including the gastrointestinal tract (inflammatory bowel disease, such as Crohn’s disease [CD] and ulcerative colitis [UC]) and joints (rheumatoid arthritis [RA]). Infliximab is a type of medication that treats a variety of IMIDs characterized by increased production of tumour necrosis factor-alpha. CT-P13 is a biosimilar of infliximab; a biosimilar is a biologic medicine that is highly similar to reference product that has been already approved, but can be more cost effective. From clinical trials and real-world studies, the comparable efficacy and safety of CT-P13 to reference infliximab was demonstrated in treating patients with IMIDs; however, few studies have looked at long-term CT-P13 treatment in Japan. This MEGA-J study investigated the safety of CT-P13 in real-world clinical practice in Japan in patients with CD, UC, and/or RA. Overall, 220 patients who were previously treated with reference infliximab and switched to CT-P13 were included in the analysis, with data reported after 2 years. The study found that CT-P13 was well tolerated in Japanese patients with CD, UC, and/or RA: most side effects were not related to CT-P13, and few patients stopped treatment due to reasons related to CT-P13. These findings show the safety and effectiveness of long-term treatment with CT-P13 for CD, UC, and RA in real-world clinical practice in Japan.