The impact of vedolizumab on COVID-19 outcomes among adult IBD patients in the SECURE-IBD registry

Agrawal, Manasi; Zhang, Xian; Brenner, Erica J; Ungaro, Ryan C; Kappelman, Michael D; Colombel, Jean-Frederic

INTRODUCTION: The impact of immune-modifying therapies on outcomes of Coronavirus disease of 2019 (COVID-19) is variable. The purpose of this study was to determine the impact of vedolizumab (VDZ), a gut-selective anti-integrin, on COVID-19 outcomes in inflammatory bowel disease (IBD) patients. METHODS: Using data from the Surveillance of Coronavirus Under Research Exclusion for IBD (SECURE-IBD), an international registry of IBD patients with confirmed COVID-19, we studied the impact of VDZ on COVID-19 hospitalization and severe COVID-19 (intensive care unit stay, mechanical ventilation and/or death). RESULTS: Of 3,647 adult patients on any IBD medication in the registry, 457 (12.5%) patients were on VDZ. On multivariable analyses using backward selection of covariates, VDZ use was not associated with hospitalization or severe COVID-19 when comparing to patients on all other medications [adjusted odds ratio (aOR) 0.87; 95% confidence interval (CI) 0.71, 1.1 and aOR 0.95; 95% CI 0.53; 1.73, respectively]. On comparing VDZ monotherapy to anti-TNF monotherapy, the odds for hospitalization, but not severe COVID-19, were higher (aOR CI 1.39; 95% CI 1.001, 1.90 and aOR 2.92; 95% CI 0.98, 8.71, respectively). In an exploratory analysis, VDZ monotherapy, compared to anti-TNF monotherapy, was associated with new-onset GI symptoms at the time of COVID-19, especially among patients whose IBD was in remission. CONCLUSIONS: COVID-19 outcomes among IBD patients on VDZ are comparable to those on all other therapies. Hospitalization, but not severe COVID-19, is more likely with VDZ monotherapy than with anti-TNF monotherapy. Overall, VDZ appears to be safe in IBD patients with COVID-19.