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

Pugliese, Daniela;Privitera, Giuseppe;Cersullo, Nicola;Bordekar, Harsh;Crispino, Federica;Mezzina, Nicolò;Pellegrini, Lucienne;Allocca, Mariangela;Laterza, Lucrezia;Viola, Anna;Bertani, Lorenzo;Soru, Pietro;Scrivo, Barbara;Barberio, Brigida;Ricci, Chiara;Balestrieri, Paola;Daperno, Marco;Pluchino, Dario;Rizzello, Fernando;Scribano, Maria Lia;Sablich, Renato;Pastorelli, Luca;Manguso, Francesco;Variola, Angela;Di Sario, Antonio;Grossi, Laurino;Ribaldone, Davide Giuseppe;Biscaglia, Giuseppe;Buda, Andrea;Mocci, Giammarco;Viscido, Angelo;Di Paolo, Maria Carla;Onali, Sara;Rodino', Stefano;Coletta, Marina;Principi, Mariabeatrice;Miranda, Agnese;Amato, Arnaldo;Bezzio, Cristina;Petruzzellis, Carlo;Mazzuoli, Silvia;Festa, Stefano;Sartini, Alessandro;Checchin, Davide;Fanigliulo, Libera;Gallina, Sara;Cesarini, Monica;Bodini, Giorgia;Stradella, Davide;Spagnuolo, Rocco;Guidi, Luisa;Savarino, Edoardo;Cappello, Maria;Caprioli, Flavio;Costa, Francesco;Fries, Walter;Scaldaferri, Franco;Fiorino, Gionata;Castiglione, Fabiana;Massari, Alessandro;Orlando, Ambrogio;Armuzzi, Alessandro

2025-01-01

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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.