Real-World Data Suggest CT-P13 Carries Lower Risk of Infection Than Remicade

Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.

The researchers, all employees of a French public organization, assessed the records of 3112 adult patients with UC in this comparative equivalence cohort study. Those who started infliximab between 2015 and 2017 were included in the study, which had a primary outcome of a composite end point of all causes of infliximab failure (including death, surgery, hospitalization, or changing to a different biologic). Follow-up started 30 days after the first infusion and continued until the onset of a predefined outcome or censoring.

In total, 1434 patients (46.1%) received reference infliximab, while 1678 (53.9%) received CT-P13. From January 2015 onward, the proportion of CT-P13 use increased as the biosimilar gained market share in France. University hospitals prescribed the biosimilar more frequently, whereas private hospitals prescribed the reference product more frequently. Patient characteristics were generally similar, although patients who were prescribed CT-P13 tended to have more severe UC.

Overall, 710 patients in the reference product group versus 743 patients in the biosimilar group met the composite end point. In multivariable analysis of the primary outcome, the biosimilar was equivalent to the reference product (hazard ratio [HR], 1.04; 95% CI, 0.94‐1.15). Multivariable analysis of secondary outcomes did not reveal any significant differences between CT‐P13 and its reference for all‐cause hospitalization, UC‐related hospitalization, UC‐related surgery, or reimbursement of another biologic therapy.

A total of 157 serious infections were identified, including 42 gastrointestinal infections. There were fewer serious infections in the CT‐P13 group (42.4 vs 51.9 per 1000 patient-years), including fewer skin and subcutaneous tissue infections (6.6 vs 12.3 per 1000 patient-years), fewer lung infections (7.3 vs 9.5 per 1000 patient-years) and fewer urinary tract infections (4.6 vs 7.3 per 1000 patient-years). Multivariable analysis demonstrated fewer serious infections in the biosimilar group (HR, 0.65; 95% CI, 0.48‐0.88).

Multivariable analysis did not demonstrate a significant difference in terms of malignancies between groups.

“Our observational study of real‐life data suggests that the effectiveness of CT‐P13 is equivalent and the risk of serious infections could be lower than that of the reference product in infliximab‐naive patients with UC,” conclude the authors.

Reference

Meyer A, Redant J, Drouin J, Coste J, Carbonnel F, Weill A. The effectiveness and safety of infliximab compared with biosimilar CT-P13, in 3112 patients with ulcerative colitis [published online May 22, 2019]. Aliment Pharmacol Ther. doi: 10.1111/apt.15323.