Single and multiple switches, swap and retransitioning among 28,073 biological drug users with inflammatory bowel diseases: results from the Italian VALORE network.
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Pellegrini Giorgia, Spini Andrea, Bellitto Chiara, L'Abbate Luca, Ingrasciotta Ylenia, Soardo Federica, Leoni Olivia, Mazzone Arianna, Ancona Domenica, Stella Paolo, Cavazzana Anna, Scapin Angela, Lopes Sara, Belleudi Valeria, Ledda Stefano, Carta Paolo, Rossi Paola, Ejlli Lucian, Sapigni Ester, Puccini Aurora, Scarpelli Rita Francesca, De Sarro Giovambattista, Tuccori Marco, Gini Rosa, Allotta Alessandra, Addario Pollina Sebastiano, Da Cas Roberto, Bucaneve Giampaolo, Mangano Antea Maria Pia, Balducci Francesco, Sorrentino Carla, Senesi Ilenia, Bernardi Francesca Futura, Trama Ugo, Spila Alegiani Stefania, Mayer Flavia, Massari Marco, Savarino Edoardo Vincenzo, Variola Angela, Trifirò Gianluca
Аннотация
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.