The authors concluded that in their analysis of real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with Crohn disease (CD) who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.
Celltrion’s CT-P13, an infliximab biosimilar approved in the United States as Inflectra and in the European Union as Remsima, is widely used in the treatment of inflammatory diseases, and was approved on the basis of studies conducted in rheumatoid arthritis and ankylosing spondylitis.
An extrapolated indication was granted for the treatment of Crohn disease (CD), and since approval, numerous real-world data have supported the use of CT-P13 in patients with CD. A new study, published this week in Annals of Internal Medicine, further underscores the safety and effectiveness of CT-P13 in this disease state.
The comparative equivalence cohort study compared CT-P13 with the reference infliximab, Remicade, in patients with CD who were naïve to infliximab therapy. In total, 5050 patients aged 15 years or older were enrolled in the study, and 2551 were given the reference infliximab, while 2499 were given the biosimilar. None of the patients had other diseases with an indication for treatment with infliximab.
The study’s primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement for another biologic treatment. The predefined equivalence margin (0.80-1.25) was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus the reference product in a multivariable marginal Cox model.
In total, 1147 patients in the reference group met the composite end point, with 838 hospitalizations. In the biosimilar group, 952 patients, with 719 hospitalizations, met the end point. In a multivariable analysis, CT-P13 was equivalent to the reference infliximab, with an HR of 1.10 (95% CI, 0.26-3.34).
There were no differences in safety outcomes between the 2 groups with respect to serious infection (HR, 0.82; 95% CI, 0.61-1.11), tuberculosis (HR, 1.10; 95% CI, 0.36-3.34), or malignancy (HR, 0.66; 95% CI, 0.33-1.32).
The authors concluded that in their analysis of the real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with CD who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.
Meyer A, Rudant J, Drouin J, Weill A, Carbonnel F, Coste J. Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: a French equivalence study [published online December 11, 2018]. Ann Intern Med. doi: 10.7326/M18-1512.