The effectiveness of biosimilar infliximab CT-P13 is equivalent to that of the reference product (RP) infliximab in infliximab-naive patients with Crohn disease, according to a study published in Annals of Internal Medicine.
Researchers utilized the Système National des Données de Santé (SNDS), a French nationwide health administrative database, to conduct a comparative equivalence cohort study of CT-P13 and RP in infliximab-naive patients. A total of 157,886 patients diagnosed with Crohn disease before December 31, 2016, were identified in the SNDS. Infliximab-naive patients with Crohn disease who received at least 1 infliximab infusion between March 1, 2015, and November 30, 2016, were included. A diagnosis of Crohn disease within 30 days of infliximab initiation was required for eligibility.
Follow-up began 30 days after the first infusion and continued until censoring or when a patient experienced a primary outcome of death or surgery related to Crohn disease, all-cause hospitalization (except for childbirth) for at least 1 night, or reimbursement for adalimumab, vedolizumab, or ustekinumab. At censoring at the end of the study, patients were switched from RP to CT-P13 (or vice versa) administered for an additional 30 days or infliximab was discontinued. Secondary outcomes were hospitalization or surgery related to Crohn disease (except for anorectal abcess or fistula surgery) or each individual item of the composite end point. Serious infections that required hospitalization (except for intestinal or anorectal abscess or fistula, tuberculosis, and solid or hematologic cancer) were also assessed.
From the total number of patients with Crohn disease elicited from the SNDS, 5050 were included in the study: 2551 (50.5%) in the RP group and 2499 (49.5%) in the CT-P13 group. Mean follow-up was 366 days in the RP group and 286 days in the CT-P13 group. During this time, 18.6% of patients in the RP group and 17.6% in the CT-P13 group discontinued infliximab; 6.3% and 8.2% of patients, respectively, switched forms of infliximab treatment.
The 6-, 12-, and 18-month cumulative incidence rates of the primary outcome were 29.6% (95% CI, 27.8-31.4), 43.1% (41.2- 45.1), and 51.5% (49.6-53.4), respectively, in the RP group and 28.6% (26.9-30.4), 41.6% (39.7- 43.6), and 50.1% (48.1 to 52.0), respectively, in the CT-P13 group. A composite event was reported in 1147 (45%) patients including 838 (32.8%) hospitalizations in the RP group, and in 952 (38.1%) patients including 719 (28.8%) hospitalizations in the CT-P13 group. Of these hospitalizations, 67.6% were related to Crohn disease.
For both groups, prior all-cause hospitalizations with a duration of >2 weeks (HR, 2.37) and prior use of adalimumab (HR, 1.20), vedolizumab (HR, 1.82), or ustekinumab (HR, 4.1) were associated with the primary outcome. No significant differences were found between both groups for all-cause hospitalization, hospitalization or surgery related to Crohn disease (except for anorectal abscess or fistula surgery), and reimbursement of another biologic therapy.
A total of 198 serious infections were reported; these include 47 (24%) skin and subcutaneous tissue infections, 40 (20%) lung infections, and 40 (20%) gastrointestinal infections (including 15 [8%] Clostridium difficile infections). However, no differences were seen in rates of serious infections between RP and CT-P13. A total of 6 patients in each group were diagnosed with tuberculosis (HR, 1.10). No significant differences were found between RP and CT-P13 for solid or hematologic cancer diagnosis (HR, 0.66).
The authors conclude that “…our observational study of real-life data suggests that effectiveness of CT-P13 is equivalent to that of RP in infliximab-naive patients.”
Meyer A, Rudant J, Drouin J, Weill A, Carbonnel F, Coste J. Effectiveness and safety of reference infliximab and biosimilar in Crohn disease: a French equivalence study [published online December 11, 2018]. Ann Intern Med. doi: 10.7326/M18-1512