Biosimilar equivalent to reference infliximab for Crohn's disease

  • Meyer A & al.
  • Ann Intern Med
  • 11 Dec 2018

  • curated by Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • The infliximab biosimilar CT-P13 is as effective and safe as reference infliximab in a large, nationwide French cohort study of patients with Crohn's disease (CD).

Why this matters

  • Largest study to date confirms smaller study.
  • Editorial concludes that: "These results suggest that switching to biosimilars should not cause concerns about effectiveness or safety."

Study design

  • Comparative equivalence cohort study of 5050 infliximab-naive patients with CD who are >15 years old, starting therapy with CT-P13 or infliximab reference product (RP) in the French nationwide health administrative database, Systeme National des Donnees de Sante.
  • Primary outcome (of effectiveness): composite outcome of death, CD-related surgery, all-cause hospitalization, reimbursement of another biologic therapy.
  • Funding: Caisse Nationale de l'Assurance Maladie.

Key results

  • By 18 months, the cumulative incidence of meeting the primary outcome was 51.5% (95% CI, 49.6%-53.4%) in the RP group and 50.1% (95% CI, 48.1%-52.0%) in the CT-P13 group.
    • CT-P13 was equivalent to RP on the primary outcome on multivariate analysis (HR, 0.92; 95% CI, 0.85-0.99) because the 95% CI was within the prespecified margin of 0.80-1.25.
  • 18.6% of RP group and 17.6% of CT-P13 group discontinued infliximab.
  • No differences between groups in serious infections, tuberculosis, and solid or hematologic cancer.

Limitations

  • Nonrandomized design.
  • No information on disease activity.
  • Administrative database.