Evidence map›Paper›PMID 42377738›Full record

Observational studyAdvances in therapy2026

Five-Year Real-World Hard Outcomes of Vedolizumab in Inflammatory Bowel Disease: The IG-IBD LONG-LIVE Study.

Giuseppe Privitera, Flavia Palumbo, Fabio Salvatore Macaluso, Lucrezia Laterza, Veronica Pardi, Anna Viola, Daniele Noviello, Brigida Barberio, Chiara Ricci, Paola Balestrieri and 35 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

45 authors.

Giuseppe PriviteraDepartment of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20072, Milan, Italy.
Flavia PalumboFederico II University Hospital, Naples, Campania, Italy.
Fabio Salvatore MacalusoVilla Sofia-Cervello Hospital, Palermo, Italy.
Lucrezia LaterzaFondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
Veronica PardiAOUP, Pisa, Italy.
Anna ViolaUOSD Malattie Intestinali Croniche, Dip. Di Medicina Clinica e Sperimentale, Policlinico Messina, Sicily, Italy.
Daniele NovielloGastroenterology and Endoscopy Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Department of Pathophysiology and Transplantation, University of Milan, Milan, Lombardia, Italy.
Brigida BarberioGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Chiara RicciGastroenterology Unit, Spedali Civili Hospital, Department of Experimental and Clinical Sciences, University of Brescia, Brescia, Italy.
Paola BalestrieriUnit of Digestive Disease of Campus Bio Medico University of Rome, Rome, Italy.
Maria CappelloHead IBD Clinic, Gastroenterology Section, Promise, University of Palermo, Sicily, Italy.
Giovanni MaconiDepartment of Biochemical and Clinical Science "L. Sacco" ASST Fatebenefratelli Sacco-University of Milan, Milan, Italy.
Renato SablichGastroenterology Unit, Santa Maria degli Angeli Hospital, Pordenone, Italy.
Angela VariolaIBD Unit, IRCCS Sacro Cuore Don Calabria, Negrar di Valpolicella, Verona, Italy.
Raffaele BennatoSurgical Department, AO Cardarelli, Naples, Italy.
Luca PastorelliGastroenterology and Hepatology Unit, ASST Santi Paolo e Carlo, 20142, Milan, Italy.
Laurino GrossiG D'Annunzio University-Digestive Physiopathology Ospedale Spirito Santo Pescara, Pescara, Italy.
Davide Giuseppe RibaldoneGastroenterology Unit, Azienda Ospedaliera Ordine Mauriziano di Torino, Turin, Piemonte, Italy.
Andrea BudaDepartment of Gastrointestinal Oncological Surgery, Gastroenterology and Endoscopy Unit, S. Maria del Prato Hospital, Feltre, Italy.
Fabrizio BossaDivision of Gastroenterology, IRCCS Ospedale Casa Sollievo Della Sofferenza, San Giovanni Rotondo, Puglia, Italy.
Antonio Di SarioClinica di Gastroenterologia, Università Politecnica delle Marche, IBD-UNIT and Dipartimento Gastroenterologico e dei Trapianti, Polo Ospedaliero-Universitario "Umberto I-G.M. Lancisi- G. Salesi", Ancona, Italy.
Angelo ViscidoGastroenterology Unit, Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy.
Benedetto NeriDepartment of Systems Medicine, Gastroenterology Unit, University "Tor Vergata" of Rome, Rome, Italy.
Giammarco MocciSC Gastroenterologia Ospedale Brotzu, Cagliari, Italy.
Cristiano PagniniDepartment of Gastroenterology and Digestive Endoscopy, S. Giovanni Addolorata Hospital, Rome, Italy.
Maria Beatrice PrincipiGastroenterology, University of Bari, Bari, Italy.
Marina ColettaGastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.
Carlo PetruzzellisDepartment of Medicine, Gastroenterology and Endoscopy, Fondazione Poliambulanza, Brescia, Italy.
Silvia MazzuoliSection of Gastroenterology and Artificial Nutrition, Hospital San Nicola Pellegrino, Bari, Italy.
Stefano FestaSan Filippo Neri Hospital, IBD Unit, Rome, Lazio, Italy.
Agnese MirarndaGastroenterology and Endoscopy Unit, University of Campania "L. Vanvitelli" Naples, Naples, Italy.
Cristina BezzioDepartment of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20072, Milan, Italy.
Libera FanigliuloGastroenterology Unit, Ospedale Santissima Annunziata, Taranto, Italy.
Giulia RoccoDivision of Gastroenterology, 'Belcolle' Hospital, Viterbo, Italy.
Elisabetta Dal PontGastroenterology Unit, Ospedale San Martino Belluno, Belluno, Italy.
Rocco SpagnuoloDivision of Gastroenterology, 'Ciaccio-Pugliese' Hospital, Catanzaro, Italy.
Edoardo Vincenzo SavarinoGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
Flavio Andrea CaprioliGastroenterology and Endoscopy Unit, La Fondazione IRCCS Ca' Granda Ospedale Maggiore di Milano Policlinico, Department of Pathophysiology and Transplantation, University of Milan, Milan, Lombardia, Italy.
Walter FriesUOSD Malattie Intestinali Croniche, Dip. Di Medicina Clinica e Sperimentale, Policlinico Messina, Sicily, Italy.
Linda CeccarelliAOUP, Pisa, Italy.
Franco ScaldaferriFondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
Ambrogio OrlandoVilla Sofia-Cervello Hospital, Palermo, Italy.
Anna TestaFederico II University Hospital, Naples, Campania, Italy.
Daniela PuglieseDepartment of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy.
Alessandro ArmuzziDepartment of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Pieve Emanuele, 20072, Milan, Italy. alessandro.armuzzi@hunimed.eu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLong-term real-world data on vedolizumab outcomes remain limited: the LONG-LIVE study evaluates 5-year effectiveness and safety in a large Italian cohort.

methodsThis 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).

resultsOverall, 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.

conclusionApproximately 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.

Indexed as

Antibodies, Monoclonal, HumanizedColitis, UlcerativeCrohn DiseaseGastrointestinal AgentsAdultAgedAge FactorsFemaleHospitalizationHumansItalyMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabDisease trajectoryEffectivenessElderlyHard outcomesLong-term observationSafetyVedolizumab

Identifiers

PMID42377738
PMCPMC13619652

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