Biosimilar CT-P13 on par with infliximab in Crohn’s Disease
CT-P13 is as effective as its reference product (RP) infliximab for infliximab-naïve patients with Crohn’s disease (CD), suggests a recent study. Safety outcomes are also comparable between the two drugs.
The composite endpoint of death, CD-related surgery, all-cause hospitalization and reimbursement of another biologic therapy present in a total of 1,147 patients in the RP group and 952 in the CT-P13 group, as well as 838 and 719 hospitalizations, respectively.
Multivariable analysis revealed that CT-P13 was on a par with RP (HR, 0.92; 95 percent CI, 0.85–0.99). There were no between-group differences observed in safety outcomes: serious infections (HR, 0.82; 0.61–1.11), tuberculosis (HR, 1.10; 0.36–3.34), and solid or haematologic cancer (HR, 0.66; 0.33–1.32).
This comparative equivalence cohort study included 5,050 infliximab-naïve CD patients aged >15 years, who had started treatment with RP (n=2,551) or CT-P13 (n=2,400) and had no other indications for infliximab. Equivalence was defined as a 95 percent CI of the HR of CT-P14 vs RP in a multivariable marginal Cox model situated within prespecified margins (0.80–1.25).
The study was limited by incomplete clinical data from the Système National des Données de Santé, a French nationwide health administrative database (1 March 2015 to 30 June 2017).
“CT-P13 is a biosimilar of the RP infliximab, with demonstrated efficacy and safety for some inflammatory arthritides. It was approved for the treatment of CD on that basis, without specific studies examining its effects in CD,” the investigators noted.