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Ustekinumab Biosimilar Switch Maintains Outcomes in Crohn's - Medscape
Medications
Ustekinumab
Biosimilars
IL-12/23 inhibitor
Clinical study
Adult patients
Patients On Biologics
Clinicians
Why This Matters
This matters because many patients and clinics face procurement-driven switches from reference biologics to biosimilars; early evidence here suggests short-term outcomes and treatment persistence are similar after switching for adults with Crohn's in remission.
Who Should Pay Attention
Adults with Crohn's disease on ustekinumab, patients considering or undergoing a biosimilar switch, gastroenterology clinicians, and researchers studying biologic interchangeability.
Study Snapshot
Story typeResearch news
Evidence typeClinical study
Source depthFull source text
What To Know
Patients with Crohn's disease in clinical remission who were switched from reference ustekinumab to approved biosimilars had similar short-term (6-month) clinical-success rates compared with those who continued reference ustekinumab in a prospective observational cohort across 18 Italian centers.
The study used an expanded clinical-success endpoint (remission without systemic steroids, no ustekinumab discontinuation, and no IBD-related hospitalization or intestinal surgery) and met a prespecified noninferiority margin at 6 months.
Adverse events and switch-backs were rare; longer follow-up and more data for every-4-week dosing were noted as limitations.
Keep In Mind
The study was observational, procurement-driven, and followed patients for 6 months only. Only four patients were on every-4-week dosing, so results may not generalize to that subgroup. Authors note these findings do not establish therapeutic equivalence or long-term interchangeability; longer-term, objective-assessment data are needed.
Source Details
Review the original publication for the complete reporting, methods, and context.
Publicationmedscape.com
Indexed viaGoogle News
Source typeWeb article
PublishedSep 1, 2026, 1:54 PM
Content availableFull source text
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.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
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