IBD: switch from infliximab to biosimilar CT-P13 appears safe

  • Bronswijk M & al.
  • Inflamm Bowel Dis
  • 10 Aug 2019

  • International Clinical Digest
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Takeaway

  • Patients with IBD treated with the TNF inhibitor infliximab can switch to biosimilar CT-P13 without increased risk for treatment discontinuation, loss of clinical remission, adverse events, or antidrug antibodies.

Why this matters

  • Concerns about therapeutic equivalence and interchangeability have limited the adoption of biosimilar medications.

Study design

  • Researchers studied patients switching from infliximab to CT-P13 at a large tertiary referral center (N=361; 54.0% men; 62% in clinical remission), assessing the pharmacokinetics, efficacy, and safety of the switch.
  • Funding: Fund for Scientific Research Flanders.

Key results

  • Clinical remission at 6 months after index infusion was independently associated with higher hemoglobin levels (HR, 1.383; P=.018) and milder patient-reported symptoms at switch (HR, 6.024; P<.0001>
  • Only 4% of patients discontinued CT-P13 therapy because of either adverse events or loss of clinical remission.
  • Overall, low numbers of patients experienced adverse events (2.2%), loss of clinical remission (2.0%), and antidrug antibodies (1.1%).

Limitations

  • The study was not powered to compare outcomes between patients with Crohn's disease and those with ulcerative colitis.
  • Study follow-up was limited to 6 months.
  • Researchers did not include endoscopic findings in efficacy endpoints.

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