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Clinical Outcomes After Ustekinumab Biosimilar Switching in Crohn’s Disease: the USBIOS IG-IBD Study

Clinical Gastroenterology and Hepatology·August 27Open Access
Gastroenterology & HepatologyConfirms priorCrohn'S DiseaseProspective Observational Cohort StudyIL-12/23 InhibitorAdultUstekinumab

Summary

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What was studied

This prospective observational cohort study at 18 Italian centers compared 6-month clinical outcomes in adults with Crohn's disease (CD) in stable remission who underwent a procurement-driven nonmedical switch from reference ustekinumab to one of 3 approved biosimilars (n=337) versus those who continued reference treatment (n=125).

Key findings

Expanded clinical success (remission, steroid-free, no biologic discontinuation, no IBD hospitalization or surgery) was achieved in 92.2% of switchers vs. 92.7% of controls (risk difference −0.5%, 95% CI −5.9 to 4.9), meeting the prespecified noninferiority margin of −15%. Biosimilar persistence was 93.7%; switch-back rate was 1.2%; only 2 adverse events were reported after switching.

Study limitations

- Observational design with unequal group sizes (337 vs. 125) and potential selection bias, despite propensity-score weighting. - Only 4 patients (0.9%) were on every-4-week dosing, so results may not generalize to this higher-intensity subgroup. - Follow-up was limited to 6 months; longer-term durability of biosimilar switching remains unknown.

Clinical implications

For clinically stable CD patients on reference ustekinumab, a nonmedical switch to an approved biosimilar appears safe and effective over 6 months, with outcomes virtually identical to staying on the reference product. Clinicians can proceed with procurement-driven switches in this population but should monitor patients on every-4-week dosing more closely, as evidence is very limited for that group.

Related Questions

Explore related topics

What does the evidence say about nonmedical switching from reference biologics to biosimilars in IBD?How do ustekinumab biosimilars compare to the reference product in terms of safety and efficacy in inflammatory bowel disease?What are the outcomes of biosimilar switching in Crohn's disease patients on higher-frequency dosing regimens?

Publication Details

Year
2026
Journal
Clinical Gastroenterology and Hepatology
Sample Size
n=462
Source
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