CT-P13 is equivalent to reference product in primary outcome; no difference in safety outcomes
TUESDAY, Dec. 11, 2018 (HealthDay News) — CT-P13, which is a biosimilar of the reference product (RP) infliximab, has equivalent effectiveness for infliximab-naive patients with Crohn’s disease (CD), according to a study published online Dec. 11 in the Annals of Internal Medicine.
Antoine Meyer, M.D., from the Hôpital Bicêtre in France, and colleagues compared the effectiveness and safety of CT-P13 and the RP in infliximab-naive patients with CD. A total of 5,050 patients with CD who were older than 15 years and had started treatment with RP (2,551 patients) or CT-P13 (2,499 patients) were included in the comparative equivalence cohort study.
The researchers found that 1,147 and 952 patients in the RP and CT-P13 groups, respectively, met the composite end point (death, CD-related surgery, all-cause hospitalization, and reimbursement of another biologic therapy); there were 838 and 719 hospitalizations, respectively. CT-P13 was equivalent to RP in multivariable analysis of the primary outcomes (hazard ratio, 0.92; 95 percent confidence interval, 0.82 to 0.99). There were no significant between-group differences in safety outcomes: serious infections (hazard ratio, 0.82; 95 percent confidence interval, 0.61 to 1.11), tuberculosis (hazard ratio, 1.1; 95 percent confidence interval, 0.36 to 3.34), and solid or hematologic cancer (hazard ratio, 0.66; 95 percent confidence interval, 0.33 to 1.32).
“Our observational study of real-life data suggests that effectiveness of CT-P13 is equivalent to that of RP in infliximab-naive patients. No difference was observed in terms of safety outcomes,” the authors write. “The choice between the two products can therefore be based on cost only.”
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