The early days of the COVID-19 pandemic proved challenging for gastroenterologists such as Ryan Ungaro, MD. Patients with inflammatory bowel disease (IBD) wanted reassurance that their therapeutic treatments did not increase their risk for infection. But the disease was so new that little was known about its impact.
“We know from previous coronaviruses such as SARS and MERS that steroids had been associated with adverse outcomes among patients with IBD, but we could not be confident the same was true for COVID-19,” says Dr. Ungaro, Assistant Professor of Medicine (Gastroenterology) at the Icahn School of Medicine at Mount Sinai. “We needed to get solid, accurate information fast so we could provide guidance to physicians and patients as to the safety of continuing their therapeutic regimen over the course of the pandemic.”
It can take years to build the robust dataset necessary to assess the risk of adverse outcomes of a disease such as COVID-19 among patients with IBD. But Mount Sinai has collaborated with the University of North Carolina at Chapel Hill to create an international registry that is making such research possible.
The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) database is an international collaborative database that has enabled monitoring of COVID-19 outcomes among patients with IBD. Using a website portal, physicians and health care providers can report all cases of polymerase chain reaction-confirmed COVID-19 among patients with IBD regardless of severity, as well as patient demographics, clinical characteristics, and therapeutics.
“We purposefully kept the reporting mechanism simple, creating an online questionnaire that could be completed in five minutes or less,” Dr. Ungaro says. “As we gathered the raw data, we made it available through the web portal, providing physicians and caregivers with a ready resource to support them in managing outcomes among their IBD patients during the COVID-19 pandemic.”
"We can reassure patients who are on TNF antagonist therapy that these therapeutics appear to be low-risk to continue during the pandemic and that keeping their disease under control far outweighs the risk of COVID-19."
Ryan Ungaro, MD
The data gathered to date has also enabled Dr. Ungaro to study the adverse effects of COVID-19 among patients with IBD. Developed in collaboration with Jean-Frederic Colombel, MD, Professor of Medicine (Gastroenterology) at the Icahn School of Medicine at Mount Sinai, the study looked at 525 COVID-19-positive cases (median age 43 years, 53 percent male) reported to the SECURE-IBD database from 28 states nationwide and 33 countries. Of those cases, 59.4 percent had Crohn’s disease, and IBD disease activity was classified as remission in 58.9 percent of cases.
The most common therapeutic treatment among patients was tumor necrosis factor (TNF) antagonist (43.4 percent overall, 33.5 percent monotherapy, and 9.9 percent combination therapy with azathioprine, 6-mercaptopurine, or methotrexate). Of the 525 cases, 161 (31 percent) were hospitalized and 37 (7 percent) had severe COVID-19—defined as intensive care unit (ICU) admission, ventilator use, and/or death. Twenty-four (5 percent) patients stayed in an ICU, 21 (4 percent) used a ventilator, and 16 (3 percent) died.
The study found that risk factors for severe COVID-19 among patients with IBD included systemic corticosteroids (aOR, 6.9; 95 percent CI, 2.3-20.5), and sulfasalazine or mesalamine (5-aminosalicylate) use (aOR, 3.1; 95 percent CI, 1.3-7.7), but a causal relationship could not be definitively established. As in other studies, age and comorbidities were also risk factors. However, anti-TNF treatment was not associated with severe COVID-19 (aOR, 0.9; CI, 0.4-2.2). The study, “Corticosteroids, But Not TNF Antagonists, Are Associated With Adverse COVID-19 Outcomes in Patients With Inflammatory Bowel Disease: Results From an International Registry,” was published in the August 2020 edition of Gastroenterology.
“Based on these results, we can reassure patients who are on TNF antagonist therapy that these therapeutics appear to be low-risk to continue during the pandemic and that keeping their disease under control far outweighs the risk of COVID-19,” Dr. Ungaro says. “As for patients on oral corticosteroids, I think this is just another reason to limit the use of steroids among IBD patients, particularly in areas where COVID-19 prevalence is high.”
Dr. Ungaro notes that the mesalamine and sulfasalazine findings were surprising in that these therapeutics had not been identified as risk factors in prior research involving other infections. But he cautions, “these findings need to be confirmed in other datasets. In the meantime, we recommend that physicians continue to administer mesalamine and sulfasalazine to their patients.”
The SECURE-IBD database continues to grow, making it possible for Dr. Ungaro to explore these findings and other COVID-19-related questions further. “For example, the data we are gathering will enable us to look at the practice patterns among gastroenterologists—whether they are holding or continuing medications among patients who are infected with COVID-19,” he says. “Eventually, our goal is to start looking at the long-term impact of COVID-19 among IBD patients to see if they have persistent symptoms and whether that impacts the course of their IBD.”
Ryan Ungaro, MD
Assistant Professor of Medicine (Gastroenterology)
Jean-Frederic Colombel, MD
Professor of Medicine (Gastroenterology)