Common IBD Meds Acquitted in Severe COVID Outcomes

Both biologics and mesalamine/sulfasalazine were not linked to severe COVID-19 outcomes in inflammatory bowel disease (IBD) patients, according to findings from the ongoing global SECURE-IBD trial.

There was no association between mesalamine/sulfasalazine and adverse COVID outcomes. And when examining biologic-treated patients, there was no link between mesalamine/sulfasalazine use and either severe COVID-19 (adjusted odds ratio [OR] 0.94, 95% CI 0.48-1.82) or COVID-19 hospitalization and/or death (aOR 1.11, 95% CI 0.82-1.50), reported Ryan Ungaro, MD, MS, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues.

There was also no association with tumor necrosis factor (TNF) antagonists and methotrexate combination therapy with COVID-related hospitalization and/or death (aOR 0.82, 95% CI 0.42-1.60) or severe illness (aOR 2.44, 95% CI 0.55-10.74), the authors wrote in Gastroenterology.

Interestingly, thiopurine combination therapy and TNF antagonists were associated with a significant risk of hospitalizations and deaths (aOR 1.82, 95% CI 1.26-2.62), but not severe COVID-19 (aOR 1.63, 95% CI 0.87-3.10), they noted.

Prior analyses of the SECURE-IBD database found an association with mesalamine/sulfasalazine and higher risk of adverse COVID-19 outcomes, the authors said.

“This finding appropriately surprised the international gastroenterology community, as 5-ASA [5-aminosalicylates/mesalamine] is considered a low risk medication with minimal systemic effects,” they wrote.

Ungaro and colleagues added that this may be due to an increasing amount of mild cases reported, which substantially attenuated the initial results.

They performed an updated analysis of the SECURE-IBD database, which included case reports from six continents, on 6,114 patients, stratified by medication class, and compared their COVID-19 outcomes. Medications assessed included thiopurines (azathioprine or 6-mercaptopurine), mesalamine or sulfasalazine, interleukin (IL)-12/23 and TNF antagonists, systemic corticosteroids, budesonide, tofacitinib (Xeljanz), methotrexate, ustekinumab (Stelara), and integrin antagonists (vedolizumab [Entyvio]).

The main outcomes provided evidence on IBD medication use related to severe COVID-19-related outcomes, such as hospitalizations, severe COVID-19 (as defined by ICU admission), and deaths.

Mean patient age was 40, with an equal distribution of men and women. More than half of all patients had Crohn’s disease (57%) and more than half had IBD disease activity in remission (55%). Most patients did not have any comorbidities (71%).

Researchers reported 27 patient deaths, including 14 among those taking TNF antagonists, eight among those taking integrin antagonists, and five among those taking IL-12/23 antagonists.

IL-12/23 and integrin antagonists were tied to lower odds of adverse COVID-19 outcomes.

“These findings continue to support a potential risk with corticosteroid therapy, but all biologic agents were not associated with adverse COVID-19-related outcomes and may, in fact have a protective effect,” said Dana Jeremy Lukin, MD, PhD, of Weill Cornell Medicine in New York City, who was not involved in this study.

“The large cohort size and consistent signals across SECURE-IBD and other large COVID-19 IBD cohorts support therapy continuation with disease-modifying, steroid-sparing therapies,” Lukin told MedPage Today. “The SECURE-IBD cohort will continue to be a valuable source of data to help inform treatment decisions during this pandemic.”

Ungaro’s group added that “providers should work with patients to wean off corticosteroids when possible.”

The analysis had several limitations, including that the use of the SECURE-IBD registry is subjective to reporting and confirmation bias, as well as unmeasured confounding. Also, patients may have discontinued use of their medication on their own, adding measurement bias.