THE IMPACT OF VEDOLIZUMAB THERAPY ON COVID-19 OUTCOMES IN ADULT IBD PATIENTS IN THE SECURE-IBD REGISTRY

ABSTRACT

Background The impact of immune-modifying therapies on outcomes of the Coronavirus disease 2019 (COVID-19) may vary depending on their mechanism of action. 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 Utilizing data from the Surveillance of Coronavirus Under Research Exclusion for IBD (SECUREIBD), an international, collaborative registry of IBD patients with confirmed COVID-19, we studied the impact of VDZ use compared to non-use, and VDZ monotherapy compared to anti-tumor necrosis factor (TNF) monotherapy, on hospitalization and severe COVID-19 (intensive care unit stay, mechanical ventilation and/or death) in adult IBD patients using multivariable logistic regression analyses. Backward selection of covariates was performed to obtain parsimonious models. P values #0.05 were considered significant for all analyses. Results Of 2,631 adult patients with confirmed COVID-19 on any IBD medication in the registry as of November 11, 2020, 312 (11.9%) patients were on VDZ of whom 236 (9.0%) were on VDZ monotherapy. A total of 731 (27.8%) patients were on an anti-TNF monotherapy. COVID-19 outcomes were similar for VDZ users versus non-users [adjusted odds ratio (aOR) 0.91, 95% confidence interval (CI) 0.74 to 1.09 for hospitalization and 1.12, 95% CI 0.60 to 2.10 for severe COVID-19, Table]. However, compared to anti-TNF monotherapy, VDZ monotherapy was positively associated with hospitalization and severe COVID-19 (aOR 1.66, 95% CI 1.17 to 2.35 and 4.71, 95% CI 1.65 to 13.45, respectively). Discussion VDZ use, compared to non-use, was not associated with adverse COVID-19 outcomes. However, when compared to anti-TNF monotherapy, VDZ monotherapy was associated with increased risk of hospitalization and ICU requirement/death. These findings suggest the comparable safety of VDZ relative to most other IBD therapies. The observed effect of anti-TNF may be related to improved safety and/or a possible protective effect against more aggressive COVID-19.(Table presented) Table Multivariable regression analyses with backward selection of covariates for COVID-19 outcomes by medication class from adult cases in the SECURE-IBD registry