December 11, 2018
By Will Boggs MD
NEW YORK (Reuters Health) - CT-P13, an infliximab biosimilar, appears to be safe and effective in infliximab-naive patients with Crohn's disease, according to a French equivalence study.
The substitution of CT-P13 for reference infliximab remains controversial because of minor structural differences between them. Two trials of CT-P13 versus reference infliximab in patients with Crohn's disease have yielded contrasting results.
Dr. Antoine Meyer and colleagues from Caisse Nationale de l'Assurance Maladie, in Paris, and Hopital Bicetre, in Le Kremlin-Bicetre, used the French nationwide health administrative database to compare the effectiveness and safety of CT-P13 and the reference product in 5,050 infliximab-naive patients with Crohn's disease.
The primary composite outcome (death, Crohn's disease-related surgery, all-cause hospitalization except childbirth for at least one night, or reimbursement of adalimumab, vedolizumab, or ustekinumab) occurred with similar frequency in the CT-P13 and reference infliximab groups: 28.6% and 29.6%, respectively, through six months; 41.6% and 43.1% through 12 months; and 50.1% and 51.5% through 18 months.
CT-P13 also proved to be equivalent to reference infliximab in multivariable analysis of the primary outcome, they report in Annals of Internal Medicine, online December 11.
There were no significant differences between the treatment groups in the individual outcomes of all-cause hospitalization, Crohn's disease-related hospitalization or surgery, or reimbursement of another biologic therapy.
Multivariable analyses also showed no significant differences between CT-P13 and reference infliximab for serious infections or solid or hematologic cancer.
The researchers caution that the database does not include all relevant clinical data and that the study did not address the question of switching from reference infliximab to CT-P13.
"Our observational study of real-life data suggests that effectiveness of CT-P13 is equivalent to that of reference infliximab in infliximab-naive patients," they conclude. "The choice between the two products can therefore be based on cost only."
Dr. Joergen Jahnsen from Akershus University Hospital, in Lorenskog, Norway, who recently reviewed the experience with biosimilar infliximab in Norway, told Reuters Health by email, "This study confirms what we know from previous studies that there are no differences between the originator infliximab and the biosimilar infliximab (CT-P13) with regard to efficacy, tolerability, and safety in the treatment of Crohn's disease."
"Physicians should be completely confident using CT-P13 in the treatment of Crohn's disease when biologics are needed," said Dr. Jahnsen, who was not involved in the new work. "Biosimilar infliximab contributes to a significant reduction in costs, and a consequence will hopefully be that this efficacious treatment will be available for many more patients."
The study had no commercial funding.
Dr. Meyer did not respond to a request for comments.
Ann Intern Med 2018.
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