Vedolizumab for ulcerative colitis: Real world outcomes from a multicenter observational cohort of Australia and Oxford

Samba Siva Reddy Pulusu, Ashish Srinivasan, Krupa Krishnaprasad, Daniel Cheng, Jakob Begun, Charlotte Keung, Daniel van Langenberg, Lena Thin, Tamara Mogilevski, Peter De Cruz, Graham Radford-Smith, Emma Flanagan, Sally Bell, Soleiman Kashkooli, Miles P. Sparrow, Simon Ghaly, Peter A. Bampton, Elise Sawyer, Susan Connor, Quart-Ul-Ain RizviJane M. Andrews, Gillian Mahy, Paola Chivers, Ian Lawrance

Research output: Contribution to journalArticle

Abstract

BACKGROUND Vedolizumab (VDZ), a humanised monoclonal antibody that selectively inhibits alpha4-beta7 integrins is approved for use in adult moderate to severe ulcerative colitis (UC) patients. AIM To assess the efficacy and safety of VDZ in the real-world management of UC in a large multicenter cohort involving two countries and to identify predictors of achieving remission. METHODS A retrospective review of Australian and Oxford, United Kingdom data for UC patients. Clinical response at 3 mo, endoscopic remission at 6 mo and clinical remission at 3, 6 and 12 mo were assessed. Cox regression models and Kaplan Meier curves were performed to assess the time to remission, time to failure and the covariates influencing them. Safety outcomes were recorded. RESULTS Three hundred and three UC patients from 14 centres in Australia and United Kingdom, [60% n = 182, anti-TNF naïve] were included. The clinical response was 79% at 3 mo with more Australian patients achieving clinical response compared to Oxford (83% vs 70% P = 0.01). Clinical remission for all patients was 56%, 62% and 60% at 3, 6 and 12 mo respectively. Anti-TNF naive patients were more likely to achieve remission than exposed patients at all the time points (3 mo 66% vs 40% P < 0.001, 6 mo 73% vs 46% P < 0.001, 12 mo 66% vs 51% P = 0.03). More Australian patients achieved endoscopic remission at 6 mo compared to Oxford (69% vs 43% P = 0.01). On multi-variate analysis, anti-TNF naïve patients were 1.8 (95%CI: 1.3-2.3) times more likely to achieve remission than anti-TNF exposed (P < 0.001). 32 patients (11%) had colectomy by 12 mo. CONCLUSION VDZ was safe and effective with 60% of UC patients achieving clinical remission at 12 mo and prior anti-TNF exposure influenced this outcome.
Original languageEnglish
Pages (from-to)4428-4441
JournalWorld Journal of Gastroenterology
Volume26
Issue number30
DOIs
Publication statusPublished - 14 Aug 2020

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