Vedolizumab May Not Worsen COVID-19 Outcomes in IBD Patients

By Brandon May

May 10, 2021

NEW YORK (Reuters Health) - Vedolizumab does not appear to worsen COVID-19 outcomes in patients with inflammatory bowel disease (IBD), according to data from the Surveillance of Coronavirus Under Research Exclusion for IBD (SECURE-IBD) registry.

"At the onset of COVID-19, there was a significant concern about what effects the virus might have on patients with IBD on immunosuppressive therapy," said Dr. Bradley Morganstern, co-director of the IBD Center at Stony Brook Medicine, in New York, who was not involved in the study.

"The data from the SECURE-IBD registry has been very reassuring and has demonstrated that most patients with IBD on immune-suppressing therapy fare similarly to the rest of the population," he told Reuters Health by email.

Immune-modifying drugs appear to vary in their effect on COVID-19-related outcomes. To assess the impact of vedolizumab, a monoclonal antibody approved for moderate-to-severe ulcerative colitis and Crohn's disease, researchers examined data from the global SECURE-IBD registry in Journal of Crohn's and Colitis.

They compared vedolizumab with other medications that have varying effects on COVID-19, including 5-aminosalisylic acid, immunomodulators, biologics, corticosteroids and some combination regimens.

A total of 457 IBD patients in the registry were on vedolizumab. When compared with all other medications in multivariable analysis, treatment with the drug was not significantly associated with hospitalization or severe COVID-19 (adjusted odds ratio, 0.87; 95% confidence interval, 0.71 to 1.1 and aOR, 0.95; 95% CI, 0.53 to 1.73, respectively).

In contrast, the odds for hospitalization were higher in patients treated with vedolizumab monotherapy compared with an anti-TNF alone (aOR, 1.39; 95% CI, 1.001 to 1.90). There was also a trend toward a higher risk of severe disease (aOR, 2.92; 95% CI, 0.98 to 8.71).

In an exploratory analysis, treatment with vedolizumab was tied to a higher incidence of new-onset GI symptoms at COVID-19 diagnosis compared with anti-TNF monotherapy treatment. This finding was particularly pronounced in patients with IBD whose disease was in remission.

Lead author Dr. Manasi Agrawal of Icahn School of Medicine at Mount Sinai, in New York City, told Reuters Health by email that the data from this study were unable to explain why hospitalizations were higher with vedolizumab compared with anti-TNF monotherapy.

"We speculate that a 'relative' protective effect on anti-TNF monotherapy and higher proportion of new-onset GI symptoms with vedolizumab may be some factors driving hospitalization," she said. "But the overall lack of severe COVID-19 outcomes among patients on vedolizumab is reassuring."

She said the results may help in developing evidence-based guidance for patients with IBD. But first, she added, additional research is needed to identify why new-onset GI symptoms were more frequent among vedolizumab-treated patients with IBD, especially among those in remission.

"The effectiveness of the COVID-19 vaccine among IBD patients on vedolizumab is also an important question that warrants further exploration," Dr. Agrawal said.

Stony Brook's Dr. Morganstern said the new findings support recommendations to continue biologic therapy despite the current pandemic.

"The next major question that we need to answer is the efficacy of vaccines in this patient population," he said, noting that current recommendations support COVID-19 vaccination in IBD patients.

"While prior studies have demonstrated that patients treated with immune-suppressing therapy are less likely to mount an adequate immune response to vaccinations in general," Dr. Morganstern explained, "there are several ongoing studies looking at the response to the COVID-19 vaccine, and the preliminary data from these studies appear reassuring."

Takeda, which sells vedolizumab under the brand name Entyvio, helped fund the study. Three of Dr. Agrawal's coauthors report financial ties to the company.

SOURCE: Journal of Crohn's and Colitis, online April 22, 2021.