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TOPLINE
Patients with Crohn's disease (CD) in clinical remission who underwent procurement-driven switching from reference ustekinumab to biosimilar versions maintained clinical success rates similar to those who continued reference treatment, with more than 92% of patients in both groups achieving the expanded clinical-success endpoint at 6 months.
METHODOLOGY
- Researchers conducted a prospective observational cohort study at 18 Italian centers involving adults with CD in clinical remission (Harvey-Bradshaw Index < 5) who had not received corticosteroids for ≥ 8 months while receiving reference ustekinumab.
- A total of 462 patients were included: 337 underwent procurement-driven switching to 1 of 3 approved biosimilars, and 125 continued reference ustekinumab treatment.
- The expanded clinical-success endpoint required clinical remission without systemic corticosteroids, no ustekinumab discontinuation, and no inflammatory bowel disease-related hospitalization or intestinal surgery during 6 months.
- Only four patients received every-4-week dosing and the remaining participants received every-8- or every-12-week treatment; the protocol-specified noninferiority margin was -15%.
TAKEAWAY
- Expanded clinical success occurred in 92.2% of patients who switched to biosimilars compared with 92.7% of those who continued reference ustekinumab, with a risk difference of -0.5% (95% CI, -5.9 to 4.9), meeting the noninferiority criterion.
- Biosimilar persistence among patients who switched to biosimilars was noted in 93.7% of those with available data, and switch-back to reference ustekinumab occurred in only 1.2% of patients.
- Adverse events after switching to biosimilar versions were reported in two patients.
- Results remained consistent after propensity-score weighting.
IN PRACTICE
"High clinical stability, treatment persistence, and rare switch-back support monitored implementation in comparable patients, but the findings do not establish therapeutic equivalence or long-term interchangeability. Longer-term evidence is particularly needed for patients receiving every-4-week ustekinumab and for outcomes based on standardized objective disease assessment," the authors of the study wrote.
SOURCE
The study was led by Davide Giuseppe Ribaldone, Department of Medical Sciences, University of Turin, Turin, Italy. It was published online on August 27 in Clinical Gastroenterology and Hepatology.
LIMITATIONS
The study's 6-month follow-up period may be insufficient to detect longer-term differences in outcomes. Only four patients received every-4-week dosing, thereby limiting generalizability. The study design was observational and had a procurement-driven switching approach.
DISCLOSURES
The study did not receive any specific funding. Some authors reported receiving research support, serving as consultants or speakers, participating in advisory boards, and having other ties with various pharmaceutical companies, including AbbVie, Eli Lilly, and Pfizer.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
