Safety, efficacy, and drug survival of the infliximab biosimilar CT-P13 in post-marketing surveillance of Japanese patients with psoriasis.

ABSTRACT: Based on extrapolation of similar clinical outcomes in rheumatoid arthritis to the originator infliximab (IFX) in randomized clinical trials, the first biosimilar antibody CT-P13 was approved for the treatment of psoriasis. To evaluate the safety, efficacy, and drug survival of CT-P13 for psoriasis in real-world clinical practice, prospective post-marketing surveillance was conducted in 165 Japanese psoriasis patients. During a 1-year follow-up period, adverse drug reactions (ADRs) occurred in 29 patients (17.6%). Infusion reaction was the most frequent ADR (6.7%), and mild pneumonia was reported as the only case of infection. Serious ADRs were reported in two patients (1.2%): acute cholecystitis and interstitial pneumonia. The interstitial pneumonia developed after a single infusion of CT

SUBMITTER: Morita A 

PROVIDER: S-EPMC9796256 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature