1. The biosimilar to infliximab, CT-P13 was shown in this study to have equivalent efficacy to the anti tumor-necrosis factor (TNF) monoclonal antibody for Crohn’s treatment.
2. There was no significant safety differences observed in this study between the two treatments for Crohn’s disease.
Evidence Rating Level: 2 (Good)
Study Rundown: Crohn’s disease is managed by a variety of different treatment options, including the anti-TNF monoclonal antibody known as infliximab. The authors of this study investigated the effectiveness and safety of a new treatment option, CT-P13, which is a biosimilar of the reference product infliximab. A similar safety and efficacy was observed in the biosimilar to infliximab for the treatment of Crohn’s disease. The main limitation of this study was that the authors used proxies to estimate disease severity, since the database utilized in the cohort study did not include all the relevant clinical data necessary for certain clinical indices of Crohn’s. Overall, the study results suggested that the biosimilar CT-P13 is comparable to infliximab.
In-Depth [comparative equivalence cohort study]: The authors of this study conducted a comparative equivalence cohort study to compare the biosimliar CT-P13 to infliximab, an anti-TNF monoclonal antibody, with regards to safety and efficacy of managing Crohn’s disease. The sample size was calculated with an expected event rate of 40% in each treatment group – patients naïve to infliximab treated with the biosimilar versus infliximab. The main endpoints were composite end point of death, Crohn’s-disease related surgery, all-cause hospitalization and reimbursement of another biologic therapy. There were no safety differences in outcomes observed between the two groups, including differences in serious infections (HR, 0.82 [CI, 0.61 to 1.11]) and tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]). Furthermore, CT-P13 was found to be equivalent to infliximab in a multivariate analysis (HR, 0.92 [95% CI, 0.85-0.99]) of the primary outcome.
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