Infliximab biosimilar safe, effective for Crohn's disease

CT-P13 and infliximab were compared in infliximab-naive patients who had recently started treatment with either drug.

CT-P13, a biosimilar of infliximab, had similar safety and efficacy for treatment of Crohn's disease in patients who had never received the latter drug, a recent study found.

Researchers in France used a nationwide health administrative database to compare the safety and effectiveness of CT-P13 and infliximab in infliximab-naive patients with Crohn's disease who were older than 15 years of age, had recently started treatment with either drug, and had no other indications for infliximab. The primary outcome measure was a composite endpoint of death, surgery related to Crohn's disease, all-cause hospitalization, and reimbursement of another biologic therapy. The results of the comparative equivalence cohort study were published Dec. 11 by Annals of Internal Medicine.

A total of 5,050 patients were included in the study, 2,551 who were taking infliximab and 2,499 who were taking CT-P13. Overall, 53.6% were women, and the median age was 33 years. Median follow-up was 366 days in the infliximab group and 286 days in the CT-P13 group. The primary endpoint was met by 1,147 patients in the infliximab group and 952 patients in the CT-P13 group, with 838 and 719 hospitalizations, respectively. In a multivariable analysis of the primary outcome, CT-P13 was found to be equivalent to infliximab (hazard ratio [HR], 0.92; 95% CI, 0.85 to 0.99). In addition, there were no between-group differences in the safety outcomes, which were serious infections (HR, 0.82; 95% CI, 0.61 to 1.11), tuberculosis (HR, 1.10; 95% CI, 0.36 to 3.34), and solid or hematologic cancer (HR, 0.66; 95% CI, 0.33 to 1.32).

Among other limitations, the authors noted that the database used in the study did not include all relevant clinical data related to disease severity and that they included only infliximab-naive patients. However, they concluded that CT-P13 and infliximab were equivalent in efficacy and safety in this observational study of real-life data, suggesting that the choice between them can be made based only on costs.

An accompanying editorial said that the study offers additional support for the conclusion that biosimilars to infliximab are a viable choice for treatment of Crohn's disease and suggests that switching to biosimilars should not raise concerns about safety or efficacy. They cautioned, however, that there are challenges associated with increased use of biosimilars and said that pharmacovigilance systems must be able to distinguish between biosimilars and the original drug so that any sign of worsened safety or efficacy can be quickly identified.

“Furthermore, when a patient is switching to a biosimilar or a treatment-naive patient is starting therapy with a biosimilar, communication must be open and clear and patient concerns must be considered,” the editorialists wrote. “Most important, to alleviate concerns, health care professionals must be proactive in increasing patients' confidence by providing evidence-based information from the growing experience with biosimilars.”