Giorgia Pellegrini, Andrea Spini, Chiara Bellitto, Luca L'Abbate, Ylenia Ingrasciotta, Federica Soardo, Olivia Leoni, Arianna Mazzone, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Stefano Ledda, Paolo Carta, Paola Rossi, Lucian Ejlli, Ester Sapigni, Aurora Puccini, Rita Francesca Scarpelli, Giovambattista De Sarro, Marco Tuccori, Rosa Gini, Alessandra Allotta, Sebastiano Addario Pollina, Roberto Da Cas, Giampaolo Bucaneve, Antea Maria Pia Mangano, Francesco Balducci, Carla Sorrentino, Ilenia Senesi, Francesca Futura Bernardi, Ugo Trama, Stefania Spila Alegiani, Flavia Mayer, Marco Massari, Edoardo Vincenzo Savarino, Angela Variola, Gianluca Trifirò
{"title":"来自意大利VALORE网络的结果：28,073例炎症性肠病生物药物使用者的单次和多次切换、交换和再转换","authors":"Giorgia Pellegrini, Andrea Spini, Chiara Bellitto, Luca L'Abbate, Ylenia Ingrasciotta, Federica Soardo, Olivia Leoni, Arianna Mazzone, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Stefano Ledda, Paolo Carta, Paola Rossi, Lucian Ejlli, Ester Sapigni, Aurora Puccini, Rita Francesca Scarpelli, Giovambattista De Sarro, Marco Tuccori, Rosa Gini, Alessandra Allotta, Sebastiano Addario Pollina, Roberto Da Cas, Giampaolo Bucaneve, Antea Maria Pia Mangano, Francesco Balducci, Carla Sorrentino, Ilenia Senesi, Francesca Futura Bernardi, Ugo Trama, Stefania Spila Alegiani, Flavia Mayer, Marco Massari, Edoardo Vincenzo Savarino, Angela Variola, Gianluca Trifirò","doi":"10.1177/17562848251378080","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>To describe the switching/swapping patterns of biological drugs in IBD patients in Italy over the last decade.</p><p><strong>Design: </strong>A retrospective cohort study was conducted using administrative data from 14 Italian regions (2010-2023) in the VALORE distributed database network.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251378080"},"PeriodicalIF":3.4000,"publicationDate":"2025-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477396/pdf/","citationCount":"0","resultStr":"{\"title\":\"Single and multiple switches, swap and retransitioning among 28,073 biological drug users with inflammatory bowel diseases: results from the Italian VALORE network.\",\"authors\":\"Giorgia Pellegrini, Andrea Spini, Chiara Bellitto, Luca L'Abbate, Ylenia Ingrasciotta, Federica Soardo, Olivia Leoni, Arianna Mazzone, Domenica Ancona, Paolo Stella, Anna Cavazzana, Angela Scapin, Sara Lopes, Valeria Belleudi, Stefano Ledda, Paolo Carta, Paola Rossi, Lucian Ejlli, Ester Sapigni, Aurora Puccini, Rita Francesca Scarpelli, Giovambattista De Sarro, Marco Tuccori, Rosa Gini, Alessandra Allotta, Sebastiano Addario Pollina, Roberto Da Cas, Giampaolo Bucaneve, Antea Maria Pia Mangano, Francesco Balducci, Carla Sorrentino, Ilenia Senesi, Francesca Futura Bernardi, Ugo Trama, Stefania Spila Alegiani, Flavia Mayer, Marco Massari, Edoardo Vincenzo Savarino, Angela Variola, Gianluca Trifirò\",\"doi\":\"10.1177/17562848251378080\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>To describe the switching/swapping patterns of biological drugs in IBD patients in Italy over the last decade.</p><p><strong>Design: </strong>A retrospective cohort study was conducted using administrative data from 14 Italian regions (2010-2023) in the VALORE distributed database network.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":48770,\"journal\":{\"name\":\"Therapeutic Advances in Gastroenterology\",\"volume\":\"18 \",\"pages\":\"17562848251378080\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-09-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12477396/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Gastroenterology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17562848251378080\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17562848251378080","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Single and multiple switches, swap and retransitioning among 28,073 biological drug users with inflammatory bowel diseases: results from the Italian VALORE network.
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.
期刊介绍：
Therapeutic Advances in Gastroenterology is an open access journal which delivers the highest quality peer-reviewed original research articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of gastrointestinal and hepatic disorders. The journal has a strong clinical and pharmacological focus and is aimed at an international audience of clinicians and researchers in gastroenterology and related disciplines, providing an online forum for rapid dissemination of recent research and perspectives in this area.
The editors welcome original research articles across all areas of gastroenterology and hepatology.
The journal publishes original research articles and review articles primarily. Original research manuscripts may include laboratory, animal or human/clinical studies – all phases. Letters to the Editor and Case Reports will also be considered.
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