ArticleTherapeutic advances in gastroenterology2025
Single and multiple switches, swap and retransitioning among 28,073 biological drug users with inflammatory bowel diseases: results from the Italian VALORE network.
Article in Therapeutic advances in gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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2 citing papers in PubMed.
- Impact of Regional Healthcare Policy Interventions on Biosimilar Use: A 10-year Evaluation of TNFα Inhibitors Utilization in Italy.Pharmaceutical medicine · 2026Article
- Short-Term Clinical and Biochemical Outcomes of IL-23p19 Inhibitors in Refractory Ulcerative Colitis: A Real-World Case Series.Inflammatory intestinal diseasesArticle
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40 authors.
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Abstract
Background: The increasing availability of biological drugs (originators and biosimilars) in the last decade for inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC), has led to complex switching patterns in real-world settings. Objectives: To describe the switching/swapping patterns of biological drugs in IBD patients in Italy over the last decade. Design: A retrospective cohort study was conducted using administrative data from 14 Italian regions (2010-2023) in the VALORE distributed database network. Methods: Patients with at least 1 year of look-back and follow-up, who initiated biological therapy with ⩾2 dispensations for IBD, were included. Switches, swaps (between biologic classes), multiple switches (⩾2), switch-backs, and re-transitioning (biosimilar to originator) were described. Predictors of multiple switches at 3 years were identified through COX regression analysis. Results: Among 28,073 first-ever users (55.8% Crohn's disease and 44.2% ulcerative colitis), most started with adalimumab (45.3%) or infliximab (39.6%). The F/M ratio was 0.79, with a median age of 41.0 years (IQR: 27.0-54.0). At 1, 3, and 5 years, switch/swap rates were 12.0%, 35.6%, and 52.6%, respectively, while multiple switches occurred in 18.7% at 5 years. Re-transitioning from biosimilar to originator occurred in 10% of patients who initially switched from originator to biosimilar of the same molecule. Tumor necrosis factor alpha (TNF-α) inhibitors switched more frequently and more rapidly than ustekinumab or vedolizumab. Depression and corticosteroid use were identified as predictors of multiple switches at 3 years of follow-up. Conclusion: About half of first-ever users of biological drugs who were treated because of IBDs switched or swapped within 5 years from treatment start. TNF-α drugs were more likely to switch or swap. They also swapped or switched more rapidly than vedolizumab and ustekinumab. Notably, 1 out of 5 had changed biologic therapy more than once at 5 years and, among those who switched to a biosimilar, 1 out of 10 re-transitioned to the originator.
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