Infliximab Biosimilar Safe and Effective Up to 5 Years

Long-term treatment with the infliximab biosimilar CT-P13 was safe and effective in patients with rheumatoid arthritis and ankylosing spondylitis, according to a 5-year retrospective analysis published online in Clinical Drug Investigation.

“Drug survival and safety were similar in [treatment-]naïve patients and switched groups, supporting switching from reference infliximab to CT-P13,” the researchers wrote.

The analysis included 491 adults with rheumatoid arthritis or ankylosing spondylitis treated with CT-P13 at five Korean hospitals between 2012 and 2017. In the United States, CT-P13 gained approval from the US Food and Drug Administration in 2016.
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Among patients with rheumatoid arthritis treated with CT-P13, 135 were infliximab-naïve, and 19 switched from reference infliximab. Among patients with ankylosing spondylitis treated with CT-P13, 219 were infliximab-naïve, and 118 switched from infliximab. According to the study, drug survival with CT-P13 was similar in infliximab-naïve and switched patients.

Treatment-emergent adverse events, most commonly upper respiratory tract infection, influenza-like illness, and urticaria, occurred in 31.8% of patients with rheumatoid arthritis and 29.4% of patients with ankylosing spondylitis, the researchers reported. Serious adverse events that were considered to be potentially drug-related occurred in 1.8% of patients (n=9), 1% of whom permanently discontinued the biosimilar (n=5).

Disease activity decreased over time, according to the study, suggesting long-term effectiveness of CT-P13.

—Jolynn Tumolo

Reference

Kim TH, Lee SS, Park W, et al. A 5-year retrospective analysis of drug survival, safety, and effectiveness of the infliximab biosimilar CT-P13 in patients with rheumatoid arthritis and ankylosing spondylitis [published online ahead of print, Apr 23, 2020]. Clin Drug Investig. doi:10.1007/s40261-020-00907-5