Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: A French equivalence study
Annals of Internal Medicine Dec 14, 2018
Meyer A, et al. - Researchers compared the effectiveness and safety of CT-P13 [biosimilar to reference product (RP) infliximab] and RP in infliximab-naive patients with Crohn disease (CD) in a comparative equivalence cohort study on 5050 subjects of age > 15 years, using a French nationwide Crohn disease administrative database (from March 1, 2015, to June 30, 2017). The primary outcome was a composite endpoint of death in 2099 cases with equivalence (ie, 95% CI of hazard ratio (HR) of CT-P13 vs RP). They observed no anomalies in safety outcomes between the 2 groups ie, serious infections, tuberculosis, and solid or hematologic cancer.
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