- 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.
- 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.
- 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%).
- 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.