Comparing real-world continuous clinical remission rates of anti-tumor necrosis factor, vedolizumab, ustekinumab, tofacitinib, and upadacitinib in ulcerative colitis

BACKGROUND: Multiple advanced therapies are available for moderate-to-severe ulcerative colitis (UC), but comparative efficacy data are limited. We compared the 1-year efficacy and safety of 7 therapies: the anti-tumor necrosis factor agents infliximab, adalimumab, and golimumab (GLM); the anti-integrin vedolizumab (VDZ); the anti-interleukin-12/23 ustekinumab (UST); and the JAK inhibitors tofacitinib (TOF) and upadacitinib (UPA). METHODS: In a retrospective, multicenter, propensity score-matched study, all UC patients treated with the 7 advanced therapies between 2014 and 2024 were included. The primary endpoint was the 1-year rate of continuous clinical remission (CCR) for each drug (defined as the induction and maintenance of steroid-free clinical remission, without the need for drug optimization or additional therapy due to relapse, with no adverse events requiring drug discontinuation). RESULTS: A total of 1406 patients were included (VDZ = 376, infliximab = 341, adalimumab = 207, UST = 150, GLM = 114, TOF = 103, UPA = 115). Excluding UPA from the overall population comparison as it was used only in bio-exposed patients, UST achieved the highest CCR, with GLM the lowest. UST appeared the most effective therapy in bio-naive patients, whereas other biologics achieved similar CCR rates. As second-line therapy, UPA achieved the highest CCR, followed by UST. As third-line therapy, UPA outperformed UST, VDZ, and TOF. UST was associated with the lowest rates of adverse events. Although UPA was associated with the highest rates of adverse events, drug withdrawal was low. CONCLUSIONS: In this large multicenter observational cohort, UST was more effective than anti-tumor necrosis factor agents and VDZ as both first- and second-line therapy. In bio-exposed patients, UPA was the most effective advanced therapy.

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Journal
Inflammatory Bowel Diseases
Published
2026-10-29
DOI
https://doi.org/10.1093/ibd/izag229
Primary Topic
Inflammatory Bowel Disease
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article
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article

Comparing real-world continuous clinical remission rates of anti-tumor necrosis factor, vedolizumab, ustekinumab, tofacitinib, and upadacitinib in ulcerative colitis

Marco Vincenzo Lenti, Annalisa De Silvestri, Federica Lepore, Chiara Ricci et al.
3 links
Inflammatory Bowel Diseases
Inflammatory Bowel Disease
article

Comparing real-world continuous clinical remission rates of anti-tumor necrosis factor, vedolizumab, ustekinumab, tofacitinib, and upadacitinib in ulcerative colitis

Marco Vincenzo Lenti, Annalisa De Silvestri, Federica Lepore, Chiara Ricci, Pietro Occhipinti, Eleonora Alimenti, Marco Michelon, Davide Stradella, Francesco Mordà, Maria Fichera, Maurizio Li Vecchi, Vito Annese, Sergio Segato, Maria Laura Annunziata, Dhanai Di Paolo, Giovanni Maconi, Antonio Lo Bello, Simone Saibeni, Fábio Pace, Nicolò Mezzina, Gianpiero Manes, Martina Mauri, Francesca Ferretti, Raffaella Ferraro, Irene Zammarchi, Valentina Casini, Valentina Zadro, Thomas Chapman, Pietro Invernizzi, Roberto Tari, Simone Segato, Guglielmo Albertini Petroni, Sandro Ardizzone, Flavio Caprioli, Luca Pastorelli, Nico Pagano, A. Cassinotti, Antonio Di Sabatino, Claudio Camillo Cortelezzi, Rosanna Cannatelli, Claudia Delogu, A. Massari, Marco Parravicini, Michele Dota, E. Anchieri, Cristina Bezzio, the A.U.R.O.R.A. 2 Study Group, Angelo Italia, Lorenzo Canova
article en

Abstract

BACKGROUND: Multiple advanced therapies are available for moderate-to-severe ulcerative colitis (UC), but comparative efficacy data are limited. We compared the 1-year efficacy and safety of 7 therapies: the anti-tumor necrosis factor agents infliximab, adalimumab, and golimumab (GLM); the anti-integrin vedolizumab (VDZ); the anti-interleukin-12/23 ustekinumab (UST); and the JAK inhibitors tofacitinib (TOF) and upadacitinib (UPA). METHODS: In a retrospective, multicenter, propensity score-matched study, all UC patients treated with the 7 advanced therapies between 2014 and 2024 were included. The primary endpoint was the 1-year rate of continuous clinical remission (CCR) for each drug (defined as the induction and maintenance of steroid-free clinical remission, without the need for drug optimization or additional therapy due to relapse, with no adverse events requiring drug discontinuation). RESULTS: A total of 1406 patients were included (VDZ = 376, infliximab = 341, adalimumab = 207, UST = 150, GLM = 114, TOF = 103, UPA = 115). Excluding UPA from the overall population comparison as it was used only in bio-exposed patients, UST achieved the highest CCR, with GLM the lowest. UST appeared the most effective therapy in bio-naive patients, whereas other biologics achieved similar CCR rates. As second-line therapy, UPA achieved the highest CCR, followed by UST. As third-line therapy, UPA outperformed UST, VDZ, and TOF. UST was associated with the lowest rates of adverse events. Although UPA was associated with the highest rates of adverse events, drug withdrawal was low. CONCLUSIONS: In this large multicenter observational cohort, UST was more effective than anti-tumor necrosis factor agents and VDZ as both first- and second-line therapy. In bio-exposed patients, UPA was the most effective advanced therapy.

Inflammatory Bowel Diseases
Vita-Salute San Raffaele University (IT), University of Milan (IT), University of Pavia (IT), Worthing Hospital (GB), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Luigi Sacco Hospital (IT), IRCCS Policlinico San Donato (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Azienda Ospedaliero Universitaria Maggiore della Carita (IT), University Hospitals Sussex NHS Foundation Trust (GB), Policlinico San Matteo Fondazione (IT), ASST Fatebenefratelli Sacco (IT), Aziende Socio Sanitaria Territoriale Rhodense (IT), Aziende Socio Sanitarie Territoriale dei Sette Laghi (IT), Azienda Socio Sanitaria Territoriale Bergamo Est (IT), University of Milano-Bicocca (IT), University of Brescia (IT)
Good health and well-being
Openalex Percentile: Top 15%
Inflammatory Bowel Disease
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