Effectiveness and Safety of Reference Infliximab and Biosimilar in Crohn Disease: A French Equivalence Study.

BACKGROUND

CT-P13 is a biosimilar of the reference product (RP) infliximab, with demonstrated efficacy and safety for some inflammatory arthritides. It was approved for the treatment of Crohn disease (CD) on that basis, without specific studies examining its effects in CD.

OBJECTIVE

To compare the effectiveness and safety of CT-P13 and RP in infliximab-naive patients with CD.

DESIGN

Comparative equivalence cohort study.

SETTING

Système National des Données de Santé (SNDS), a French nationwide health administrative database (1 March 2015 to 30 June 2017).

PATIENTS: 5050 infliximab-naive patients with CD who were older than 15 years, had started treatment with RP (n = 2551) or CT-P13 (n = 2499), and had no other indications for infliximab.

MEASUREMENTS: The primary outcome was a composite end point of death, CD-related surgery, all-cause hospitalization, and reimbursement of another biologic therapy. Equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus RP in a multivariable marginal Cox model situated within prespecified margins (0.80 to 1.25).

RESULTS

Overall, 1147 patients in the RP group and 952 patients in the CT-P13 group met the composite end point (including 838 and 719 hospitalizations, respectively). In multivariable analysis of the primary outcome, CT-P13 was equivalent to RP (HR, 0.92 [95% CI, 0.85 to 0.99]). No differences in safety outcomes were observed between the 2 groups: serious infections (HR, 0.82 [CI, 0.61 to 1.11]), tuberculosis (HR, 1.10 [CI, 0.36 to 3.34]), and solid or hematologic cancer (HR, 0.66 [CI, 0.33 to 1.32]).

LIMITATION: The SNDS does not contain all relevant clinical data (for example, disease activity).

CONCLUSION

This analysis of real-world data indicates that the effectiveness of CT-P13 is equivalent to that of RP for infliximab-naive patients with CD. No difference was observed for safety outcomes.

PRIMARY FUNDING SOURCE: Caisse Nationale de l'Assurance Maladie.