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).
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.
- 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.
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.
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