Cure8 research brief
If you’re stable on ustekinumab for Crohn’s disease, this multicenter study found that switching to an approved biosimilar produced similar 6-month remission and safety outcomes to staying on the original product. That could matter where nonmedical switching is being considered for cost or supply reasons.
Adult patients with Crohn’s disease who are stable on ustekinumab, clinicians managing biologic therapy, and researchers studying biosimilars and switching strategies.
This prospective multicenter observational study compared 6-month outcomes after nonmedical switching from reference ustekinumab to approved biosimilars versus continuing the reference drug in adults with clinically stable Crohn’s disease.
The primary expanded clinical-success endpoint required maintained clinical remission without systemic steroids, discontinuation of anti–IL-12/23 therapy, IBD-related hospitalization, or intestinal surgery. About 462 patients were included (337 switched, 125 continued reference).
Expanded clinical success at 6 months was similar between groups (92.2% switched vs 92.7% continued; risk difference -0.5%, 95% CI -5.9 to 4.9), meeting the study’s prespecified noninferiority margin of -15%. Biosimilar persistence was high (93.7%) and switch-back was uncommon (1.2%); two adverse events were reported after switching.
The study suggests that in patients already stable on ustekinumab, procurement-driven switching to an approved biosimilar showed similar short-term effectiveness and safety to continuing reference ustekinumab. The authors note limitations including the 6-month follow-up and small numbers on every-4-week dosing.
This report is an abstract-level summary of a prospective observational cohort with 6-month follow-up. It does not provide longer-term outcomes or detailed subgroup data for patients on every-4-week dosing. As an observational study, residual confounding is possible despite propensity-score analyses.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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