For Crohn’s, infliximab and its biosimilar perform similarly

  • Lancet

  • International Clinical Digest
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Takeaway

  • In a trial of biologic-naive patients with Crohn’s disease, the infliximab (Remicade; Janssen Biotech, Inc.) biosimilar CT-P13 was of noninferior efficacy and comparable safety to infliximab at 6 weeks.

Why this matters

  • Biosimilars may save payors money.
  • Because of regulatory indication extrapolation, CT-P13 was FDA-approved for diseases treated by infliximab, such as Crohn’s, without being compared with infliximab in a trial of patients with Crohn’s.

Study design

  • Randomized multicenter double-blind phase 3 noninferiority trial (n=220).
  • Participants had active Crohn’s, had not benefited from nonbiological treatments, and were naive to biologicals.
  • They were randomly assigned to take:
    • CT-P13, then CT-P13;
    • CT-P13, then infliximab;
    • infliximab, then infliximab; or
    • infliximab, then CT-P13.
    • They switched at week 30, until week 54.
  • Outcome: proportion with decrease ≥70 points in Crohn’s Disease Activity Index (CDAI; CDAI-70 response) from baseline to week 6.
  • Noninferiority margin set at −20%.
  • Funding: Celltrion; Pfizer.

Key results

  • CT-P13 vs infliximab:
    • 6-week CDAI-70:
      • 69.4% (77/111; 95% CI, 59.9%-77.8%) vs 74.3% (81/109; 95% CI, 65.1%-82.2%);
      • Difference, −4.9% (95% CI, −16.9% to 7.3%), meeting nonferiority criterion.
    • Similar results in per-protocol population.
    • Similar results at weeks 14 and 30.
    • Similar response and remission rates at multiple timepoints.
    • Similar adverse event rates.

Limitations

  • Long-term efficacy not proven.

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