Data from a large, nationwide, observational cohort study demonstrate that switching from reference infliximab to biosimilar infliximab-abda in patients with inflammatory bowel disease was safe and efficacious compared with continuing reference infliximab.
Several biosimilars to approved biologic agents have been developed for the management of a variety of immune-mediated inflammatory disorders, such as moderate-to-severe inflammatory bowel disease (IBD), including both Crohn’s disease (CD) and ulcerative colitis (UC). A large, nationwide, prospective, observational cohort study was conducted to evaluate the efficacy and safety of biosimilars in patients with IBD who switched from reference infliximab to biosimilar infliximab-abda compared with those who continued reference infliximab; the results of this study were presented at the American College of Gastroenterology 2020 meeting.
The chart review identified eligible patients with CD or UC who had received ≥1 doses of either infliximab or infliximab-abda from 2018 to 2019 at the Cleveland Clinic. Eligible patients were randomized into 2 cohorts; the first cohort included patients authorized for a nonmedical switch from infliximab to infliximab-abda, and the second cohort included patients who continued on infliximab. Statistical analysis consisted of between-cohort comparisons using nonparametric testing for continuous variables and categorical variables (α ≤0.05).
A total of 359 patients were included in the analysis; of these, 99 patients were switched from infliximab to infliximab-abda and 101 continued infliximab therapy. In terms of baseline demographics, the mean age of the total cohort was 41.95 years, 49% were male, and 87% were white. A higher proportion of patients with CD were included than UC in both cohorts. No clinically significant differences were observed in the use of corticosteroid taper and maintenance, fecal calprotectin, infliximab concentrations, antibody levels, and hospital and emergency department admissions.
The results of the observational study demonstrated that nonmedical switch from reference infliximab to biosimilar infliximab-abda was safe and efficacious compared with continuing reference infliximab therapy in patients with IBD.
Padival R, et al. American College of Gastroenterology (ACG) 2020 Virtual Annual Scientific Meeting & Postgraduate Course. Abstract P1625.