Is there a difference in safety and efficacy between reference infliximab and biosimilar CT-P13?
Reference infliximab and biosimilar CT-P13 appeared to yield similar outcomes in a large, real-world cohort. These data support use of biosimilars in treatment-naïve patients.
Meyer A, Rudant K, Drouin J, et al. Effectiveness and Safety of Reference Infliximab and Biosimilar in Crohn Disease: A French Equivalence Study. Ann Intern Med. 2019;170(2):99–107. DOI: 10.7326/M18-1512
The infliximab biosimilar CT-P13 (Inflectra; Celltrion) was approved in Canada in 2016 for the treatment of Crohn’s disease (CD), fistulising CD and ulcerative colitis. That approval was based on studies examining the equivalence of CT-P13 and reference infliximab (Remicade; Janssen Biotech) for the treatment of rheumatoid arthritis and spondyloarthritis.
In this study, French researchers examined data from 2,551 CD patients who received reference infliximab and 2,499 who received CT-P13. Patients were registered in a large French administrative database that includes nearly all of the French population. The median follow-up was 366 days for reference infliximab recipients and 286 days for biosimilar recipients. Patients received at least one infliximab infusion between March 2015 and November 2016.
The researchers’ primary end-point was a composite of death, CD-related surgery, all-cause hospitalization, and reimbursement for adalimumab, vedolizumab and ustekinumab, which they used as a proxy measure of infliximab treatment failure.
Results showed no differences in the composite end-point between groups, with 43.1% of reference infliximab recipients and 41.6% of CT-P13 recipients meeting the end-point at one year. A multivariable analysis confirmed rates of this outcome were statistically similar in the two cohorts (Hazard Ratio for composite end-point for CT-P13 vs. reference infliximab, 0.92; 95% Confidence Interval, 0.85 to 0.99; P not significant). Additionally, rates of serious infections, tuberculosis and solid or hematologic cancer did not differ between groups.
The researchers noted that a weakness of the study was that the French database did not contain clinical data such as disease activity.
Study Design: Observational cohort
Funding: Caisse Nationale de l’Assurance Maladie
Allocation: Not applicable
Level of Evidence: 2b (Oxford Levels of Evidence)
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