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. 2025 Sep 28:18:17562848251378080.
doi: 10.1177/17562848251378080. eCollection 2025.

Single and multiple switches, swap and retransitioning among 28,073 biological drug users with inflammatory bowel diseases: results from the Italian VALORE network

Giorgia Pellegrini  1 , Andrea Spini  1 , Chiara Bellitto  1 , Luca L'Abbate  1 , Ylenia Ingrasciotta  1 , Federica Soardo  1 , Olivia Leoni  2 , Arianna Mazzone  3 , Domenica Ancona  4 , Paolo Stella  4 , Anna Cavazzana  5 , Angela Scapin  5 , Sara Lopes  6 , Valeria Belleudi  6 , Stefano Ledda  7 , Paolo Carta  7 , Paola Rossi  8 , Lucian Ejlli  8 , Ester Sapigni  9 , Aurora Puccini  9 , Rita Francesca Scarpelli  10 , Giovambattista De Sarro  11 , Marco Tuccori  1 , Rosa Gini  12 , Alessandra Allotta  13 , Sebastiano Addario Pollina  13 , Roberto Da Cas  14 , Giampaolo Bucaneve  15 , Antea Maria Pia Mangano  16 , Francesco Balducci  17 , Carla Sorrentino  18 , Ilenia Senesi  19 , Francesca Futura Bernardi  20   21 , Ugo Trama  20 , Stefania Spila Alegiani  14 , Flavia Mayer  14 , Marco Massari  14 , Edoardo Vincenzo Savarino  22 , Angela Variola  23 , Gianluca Trifirò  24
Affiliations

Single and multiple switches, swap and retransitioning among 28,073 biological drug users with inflammatory bowel diseases: results from the Italian VALORE network

Giorgia Pellegrini et al. Therap Adv Gastroenterol. .

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.

Keywords: biologics; biosimilars; real-world evidence.

Plain language summary

Switching patterns of biologic drugs in IBD patients: results from the Italian VALORE project Over the past decade, the availability of different biologic treatments for inflammatory bowel disease (IBD), including Crohn’s disease and ulcerative colitis, has increased. As more new biologic drugs and biosimilars become available, the way IBD patients switch between these treatments is becoming more complex. This study looked at real-world data from over 28,000 IBD patients across 14 Italian regions between 2010 and 2023 to understand how often patients switch treatments and what factors might influence these switches. We found that treatment switches are common: 12% of patients switched drugs within a year, 36% within three years, and 53% within five years. Many patients switched from originator drugs to biosimilars, although about 10% later on returned to the originator drug. Nearly 1 in 5 patients had two or more switches over five years. Those with a history of corticosteroid use or depression were more likely to switch multiple times, highlighting the need for more tailored care and closer follow-up of specific categories of patients.

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Figures

Switch, swap, and multiple switches among index drugs in medical switches (B), non-medical switches (A), medical switch (B), and non-medical switch (A). Single switch, single swap, medical multiple switches, non-medical multiple switches, retransitioning, switch back. Biosimilar, different biologics, different pharmacological class. Switch drugs different color, blue.
Figure 1.
Definitions of switch, swap, and multiple switches. *Biosimilar; different letters: different biologics; different colors: different pharmacological class.
Flowchart showing numbers of new biogeneric drug users from 2010-2023 in the US
Figure 2.
Flow chart of first-ever users of biological drugs included in the study.
Frequency of Switch, Swap and Multiple switches in Crohn’s disease and ulcerative colitis patients.
Figure 3.
Frequency of switch, swap, multiple switches, and switch back in Crohn’s disease and ulcerative colitis patients.
Sunburst chart depicting the prevalence of Crohn’s disease and ulcerative colitis over two time periods, highlighting specific biologic treatments and their origins.
Figure 4.
Sunburst chart illustrating the use of biological drugs across different lines of treatment, stratified by active ingredient and type (originator vs biosimilar). The figure compares the periods 2010–2016 and 2017–2023.
“The image depicts adjusted predictors of multiple switches, at least two changes of active ingredient, at three years for Crohn′s disease and ulcerative colitis, stratified by indication for use. Both diseases show multiple factors associated with an increased hazard ratio (HR) indicating a higher probability of switching medications within a set period. The most significant predictors for Crohn’s disease are Infliximab, Adalimumab, and Ulkesminib, which shows a high HR when switched to another medication.
Figure 5.
Adjusted predictors of multiple switches (at least two changes of active ingredient) at 3 years stratified by indication for use.
See this image and copyright information in PMC

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