Five-Year Real-World Hard Outcomes of Vedolizumab in Inflammatory Bowel Disease: The IG-IBD LONG-LIVE Study
Year: 2026
Type: article
Study design: Observational Study
Abstract: Long-term real-world data on vedolizumab outcomes remain limited: the LONG-LIVE study evaluates 5-year effectiveness and safety in a large Italian cohort. This is a long-term extension of the multicenter LIVE study involving patients with Crohn’s disease (CD) and ulcerative colitis (UC). The primary outcome was the cumulative probability of major adverse clinical outcomes (the composite of IBD-related surgeries, non-surgical hospitalizations, and serious adverse events). Secondary outcomes included cumulative incidences of IBD-related surgery and non-surgical hospitalization, vedolizumab persistence, rates of death, cancer and adverse events of special interest (AESIs), and longitudinal response group transitions; outcomes in elderly patients (≥ 65 years) were compared to non-elderly using inverse probability weighting (IPW). Overall, 782 patients were included (50.4% CD; 49.6% UC; 76.3% anti-tumor necrosis factor (TNF)-experienced; 4324.1 patient-years of follow-up). The 5-year probability of major adverse clinical outcomes was 29.4% (no difference between CD and UC). In CD, penetrating behavior (aHR 1.77) predicted higher risk of the primary endpoint, while colonic location was protective (aHR 0.51). In UC, the primary endpoint was predicted by elderly age (aHR 1.99) and comorbidity burden (aHR 1.27). Five-year cumulative incidences were 23.4% for surgery and 14.3% for non-surgical hospitalization. Patients with CD had higher hospitalization risk than patients with UC (sHR 1.80). Mortality, neoplasm diagnosis, and AESIs occurred at rates of 3.93, 3.93, and 6.27 per 1000 patient-years. Five-year drug persistence was 38.7%. Achieving deep remission within 24 months mediated the relationship between initial clinical response and sustained deep remission at last follow-up. After IPW, elderly patients had a higher risk of major adverse clinical outcomes and non-surgical hospitalization; AESI and cancer rates did not differ. Approximately one in three patients experienced a major adverse clinical outcome over 5 years, driven primarily by disease-related complications rather than adverse events, with a consistent safety profile across age groups. Vedolizumab is a gut-selective biologic therapy approved for Crohn's disease (CD) and ulcerative colitis (UC). While its short-term effectiveness is well established, data on what happens to patients beyond 2 years of treatment remain limited. In this study, we followed 782 patients for up to 7 years across 47 Italian centers to track hard clinical outcomes: surgery, hospitalization, serious adverse events, and death. About one in three patients experienced a major adverse clinical outcome over 5 years—a composite endpoint that includes IBD-related surgeries, non-surgical hospitalizations, and serious adverse events—with no meaningful difference between CD and UC. Surgery occurred in approximately one in five patients, and non-surgical hospitalizations were more frequent in CD. Serious adverse events, including deaths, cancers, and infections, remained uncommon throughout follow-up. Patients who responded early to treatment were more likely to achieve deep remission within 2 years, which was in turn associated with deep remission at last follow-up. Elderly patients faced higher risks of hospitalization and major adverse clinical outcomes, but not of cancer or serious adverse events, suggesting that vedolizumab can be used across different age groups without a disproportionate increase in safety risk.
Source: Advances in Therapy
Authors: Giuseppe Privitera, Flavia Palumbo, Fabio Salvatore Macaluso, Lucrezia Laterza, Veronica Pardi, Anna Viola, Daniele Noviello, Brigida Barberio, Chiara Ricci, Paola Balestrieri, Maria Cappello, Giovanni Maconi, Renato Sablich, Angela Variola, Raffaele Bennato, Luca Pastorelli, Laurino Grossi, Davide Giuseppe Ribaldone, Andrea Buda, Fabrizio Bossa, Antonio Di Sario, Angelo Viscido, Benedetto Neri, Giammarco Mocci, Cristiano Pagnini, Maria Beatrice Principi, Marina Coletta, Carlo Petruzzellis, Silvia Mazzuoli, Stefano Festa, Agnese Mirarnda, Cristina Bezzio, Libera Fanigliulo, Giulia Rocco, Elisabetta Dal Pont, Rocco Spagnuolo, Edoardo Vincenzo Savarino, Flavio Andrea Caprioli, Walter Fries, Linda Ceccarelli, Franco Scaldaferri, Ambrogio Orlando, Anna Testa, Daniela Pugliese, Alessandro Armuzzi
Institutions: Humanitas University, Federico II University Hospital, Ospedale Vincenzo Cervello, Agostino Gemelli University Polyclinic, University of Milan, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Padua, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Brescia, Università Campus Bio-Medico, Campus Bio Medico University Hospital, University of Palermo, ASST Fatebenefratelli Sacco, Azienda Ospedaliera Santa Maria Degli Angeli, Ospedale Antonio Cardarelli, Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo, University of Chieti-Pescara, A. O. Ordine Mauriziano di Torino, Hospital of Prato, Casa Sollievo della Sofferenza, Marche Polytechnic University, Azienda Ospedaliero-Universitaria delle Marche, University of L'Aquila, University of Rome Tor Vergata, Azienda Ospedaliera G. Brotzu, Azienda Ospedaliera San Giovanni Addolorata, University of Bari Aldo Moro, Fondazione Poliambulanza Istituto Ospedaliero, Ospedale San Filippo Neri, University of Campania "Luigi Vanvitelli", IRCCS Humanitas Research Hospital, Ospedale di Belcolle, Azienda Ospedaliera Pugliese Ciaccio, Università Cattolica del Sacro Cuore, Istituti di Ricovero e Cura a Carattere Scientifico
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $4,790
Funder: Takeda Pharmaceuticals U.S.A.
OpenAlex ID: W7166652491