Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: A multicenter study.

Abstract

Adalimumab has emerged as a useful drug for treating patients with Crohn's disease (CD) and ulcerative colitis (UC), not responding to conventional therapy. There is limited data on effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease (IBD). Patients with IBD who received at least one dose of adalimumab biosimilar from October 2015 to February 2018 were retrospectively included in this multicenter data analysis. Its effectiveness in inducing and maintaining clinical remission at 8, 26, and 52weeks for CD and UC and safety profile of thedrug was studied. Seventy patients (49 CD; 21 UC) with a median age of 39 (range 13-73) years, male predominance (64.3%), and median (IQR) disease duration of 72 (33-104) months were included. Adalimumab biosimilar was effective in inducing remission (at 8weeks) in 46.9% and 52.4% patients with CD and UC, respectively, of whom 32.7% and 33.3% (three fourths of remitters) maintained remission over 1year, respectively. Twenty (28.6%) patients experienced adverse events; seven (10%) were serious of whom three had developed tuberculosis. Adalimumab biosimilar in usual clinical practice is safe and effective in inducing and maintaining remission in Indian patients with IBD. Steroid-free clinical remission was observed in one third of patients withUC and CD at 1year of therapy. Graphical Abstract.