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Observational Study
. 2025 Jul;57(7):1393-1402.
doi: 10.1016/j.dld.2025.04.021. Epub 2025 May 12.

Vedolizumab in inflammatory bowel disease: Real-world outcomes and their prediction with machine learning-the IG-IBD LIVE study

Daniela Pugliese  1 , Giuseppe Privitera  2 , Nicola Cersullo  3 , Harsh Bordekar  3 , Federica Crispino  4 , Nicolò Mezzina  5 , Lucienne Pellegrini  6 , Mariangela Allocca  7 , Lucrezia Laterza  8 , Anna Viola  9 , Lorenzo Bertani  10 , Pietro Soru  11 , Barbara Scrivo  12 , Brigida Barberio  13 , Chiara Ricci  14 , Paola Balestrieri  15 , Marco Daperno  16 , Dario Pluchino  17 , Fernando Rizzello  18 , Maria Lia Scribano  19 , Renato Sablich  20 , Luca Pastorelli  21 , Francesco Manguso  22 , Angela Variola  23 , Antonio Di Sario  24 , Laurino Grossi  25 , Davide Giuseppe Ribaldone  26 , Giuseppe Biscaglia  27 , Andrea Buda  28 , Giammarco Mocci  29 , Angelo Viscido  30 , Maria Carla Di Paolo  31 , Sara Onali  32 , Stefano Rodino'  33 , Marina Coletta  34 , Mariabeatrice Principi  35 , Agnese Miranda  36 , Arnaldo Amato  37 , Cristina Bezzio  38 , Carlo Petruzzellis  39 , Silvia Mazzuoli  40 , Stefano Festa  41 , Alessandro Sartini  42 , Davide Checchin  43 , Libera Fanigliulo  44 , Sara Gallina  45 , Monica Cesarini  46 , Giorgia Bodini  47 , Davide Stradella  48 , Rocco Spagnuolo  49 , Luisa Guidi  8 , Edoardo Savarino  13 , Maria Cappello  12 , Flavio Caprioli  11 , Francesco Costa  50 , Walter Fries  9 , Franco Scaldaferri  8 , Gionata Fiorino  51 , Fabiana Castiglione  6 , Alessandro Massari  5 , Ambrogio Orlando  4 , Alessandro Armuzzi  52
Affiliations
Observational Study

Vedolizumab in inflammatory bowel disease: Real-world outcomes and their prediction with machine learning-the IG-IBD LIVE study

Daniela Pugliese et al. Dig Liver Dis. 2025 Jul.

Abstract

Background and aims: Real-world studies on vedolizumab in inflammatory bowel disease (IBD) are often limited by small sample size and short follow-up. In this study, we investigated the 2-year effectiveness and safety of vedolizumab in patients with IBD, and applied eXplainable Artificial Intelligence (XAI) to identify predictors of both.

Methods: The Long-term Italian Vedolizumab Effectiveness (LIVE) study is multicentric, ambispective, observational study enrolling 1111 IBD patients (563 Crohn's disease, CD, 542 ulcerative colitis, UC). Steroid-free clinical remission (SFCR) at 24 months was the primary endpoint. A XAI model (eXtreme Gradient Boosting, XGB) was applied to identify the main clinical predictors of SFCR and development of adverse events (AEs).

Results: Rates of SFCR at 24 months were 31.6 % and 39.7 % in CD and UC patients, and 0.14 AEs per patient-year was recorded. On XGB analysis, previous exposure to anti-TNFα and older age were the most important drivers for the prediction of SFCR; lower baseline CRP levels and fewer comorbidities were the most important features associated with no development of AEs.

Conclusions: Vedolizumab is effective and safe in IBD patients. XAI yielded promising results in identifying the most important predictors of SFCR and development of AEs.

Keywords: Anti-integrin therapy; Machine learning (ML); Shapley values (SHAP).

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Conflict of interest statement

Conflict of interest Daniela Pugliese received speaker fees and/or advisory board from AbbVie, Galapagos, MSD, Takeda and Janssen, Pfizer. Giuseppe Privitera received consultancy fees from Alphasigma and Janssen. Alessandro Armuzzi: consulting and/or advisory board fees from AbbVie, Amgen, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda; lecture and/or speaker bureau fees from AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mitsubishi-Tanabe, Novartis, Pfizer, Roche, Sandoz, Samsung Bioepis, Takeda; and research grants from MSD, Pfizer, Takeda and Biogen. The remaining authors declare no competing interests.

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