Real-World Data Indicate Biosimilar Infliximab Is Effective, Safe in Crohn’s Disease

January 29, 2019

Biosimilars Team

An analysis of real-world data indicates that the effectiveness of CT-P13 (available in the United States as Inflectra, infliximab-dyyb) is equivalent to reference infliximab (Remicade) for infliximab-naive patients with Crohn’s disease.  The analysis was published in the January 15 issue of Annals of Internal Medicine.

The real-life comparative equivalence cohort study was conducted using the Système National des Données de Santé (SNDS), a nationwide health administrative database that covers more than 99% of the French population (around 65 million people).  The study population encompassed infliximab-naive patients with Crohn’s disease who received at least one infliximab infusion between March 1, 2015, and November 30, 2016.  An infliximab-naive patient was defined as a patient who had not been reimbursed for infliximab during the previous 12 months.  Patients were excluded if they were younger than 15 years of age or had other indications for infliximab therapy.

A total of 5,050 individuals from 530 hospitals were included in the analysis.  Patients were assigned to groups based on whether the first infliximab reimbursement was for the reference product (2,551; 50.5%) or CT-P13 (2,499; 49.5%).

Follow-up started 30 days after the first infusion and continued until onset of a predefined outcome or censoring.  The primary outcome was a composite end point of death, surgery related to Crohn’s disease, all-cause hospitalization, and reimbursement of another biologic therapy.  Patients were censored at study end on June 30, 2017; after a switch from reference product to CT-P13 (or vice versa) plus 30 days; or upon discontinuation of infliximab.

Treatment equivalence was defined as a 95% CI of the hazard ratio (HR) of CT-P13 versus the reference product in a multivariable marginal Cox model situated within prespecified margins (0.80 to 1.25).

The median follow-up was 366 days (interquartile range 195–605 days) in the reference product group and 286 days (interquartile range interquartile range 184–432 days) in the CT-P13 group. Overall, 1,147 patients in the reference product group and 952 patients in the CT-P13 group met the composite end point.  There were 838 hospitalizations in the reference product group and 719 hospitalizations in the CT-P13 group.

In multivariable analysis of the primary outcome, CT-P13 was equivalent to the reference product (HR = 0.92; 95% CI 0.85 to 0.99). No significant differences in safety outcomes were observed between the two groups for serious infections (HR = 0.82; CI 0.61 to 1.11), tuberculosis (HR = 1.10; CI 0.36 to 3.34), or solid or hematologic cancer (HR = 0.66; CI 0.33 to 1.32).

The authors concluded that given the observed equivalent efficacy and no difference in safety outcomes, the choice between CT-P13 and reference infliximab can be based on cost only.


Meyer A, Rudant J, Drouin J, et al.  Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: a French equivalence study.  Ann Intern Med.  2019 Jan 15;170(2):99-107. doi: 10.7326/M18-1512. Epub 2018 Dec 11.