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Because CT-P13, a biosimilar to originator infliximab, was approved for treating Crohn disease based on extrapolation of efficacy in rheumatoid arthritis, further data have been sought in patients with Crohn disease.
In an industry-funded, randomized, double-blind study, researchers tested the noninferiority of CT-P13 to infliximab in patients with active luminal inflammatory Crohn disease who had never taken biologics. They randomized 220 patients from 58 centers to receive infliximab or CT-P13 for 30 weeks and then either infliximab or CT-P13 through study end at week 54.
At week 6, the percentage of patients with response to treatment (a decrease of ≥70 points in the Crohn disease activity index score; primary endpoint) was similar between…