SECURE-IBD Provides Answers During Uncertain Times

  • Marla Broadfoot

When the COVID-19 pandemic hit U.S. soil, Jessica Burris, a first-year medical resident at Yale, was told to stay home. Although most cases of COVID-19 were mild, the disease could turn severe or fatal for people at high risk, such as the elderly or those with pre-existing conditions or compromised immune systems. Burris, who takes immunosuppressants to control her inflammatory bowel disease (IBD), worried that she might fall into that category.

Jessica Burris, MD

"I felt like I was at a sort of 'high stakes, sparse information' crossroads," says Burris. "I originally entered the field of medicine to answer a deep calling to serve in settings of suffering, and the chaos and pain associated with the COVID-19 pandemic only strengthened these convictions. However, comparatively little was known at that time about COVID-19."

Then she and her doctor discovered a database that was monitoring and reporting outcomes of COVID-19 in people with IBD. The SECURE-IBD (Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease) database was designed by researchers at the University of North Carolina at Chapel Hill and Mount Sinai to answer questions that patients with IBD and their caregivers might have during these uncertain times.

Michael D. Kappelman, MD, MPH

The idea for the database came to UNC-Chapel Hill pediatric gastroenterologist Mike Kappelman late one night while he was brainstorming ways to help his patients during the pandemic. He quickly called up his GI fellow Erica Brenner, who thought it sounded like a great endeavor. The next morning, they reached out to UNC's North Carolina Translational and Clinical Sciences (NC TraCS) Institute for help.

Erica Brenner, MD

Experts there helped them design the project so it would de-identify patients' personal health information; create space for the survey in a secure web application; and craft a logo and website for sharing with other health care providers. "Their expertise and flexibility enabled us to kick-start the project rapidly," said Brenner.

Within three days, they planned and launched a database that enables health care providers from around the globe to voluntarily report cases of IBD who develop COVID-19, their IBD medications, and their outcomes. As of May 25, SECURE-IBD housed reports from 1302 patients in 42 different countries, including the United States, Canada, Spain, Brazil, and the United Kingdom. The database has also resulted in several spin-off projects collecting disease-specific COVID-19 data for other conditions like atopic dermatitis and cirrhosis.

The researchers update the SECURE-IBD website with new data every week. That data shows the number of reported cases, geographic location of reported cases, and summaries of COVID-19 outcomes according to patient age, sex, smoking status, medication use, and other factors. After only a few weeks, the researchers began noticing some interesting trends. For example, older patients and those with several health conditions appeared to be at higher risk of severe COVID-19 outcomes, mirroring what had been seen in other studies of the general population.

Importantly, their data suggested that different medications used to treat IBD are associated with different outcomes of COVID-19. Patients who were treated with corticosteroids like prednisone, but not biologics like tumor necrosis factor (TNF) antagonists, were more likely to experience severe outcomes, such as landing in the ICU, being put on a respirator, or death.

Ryan Ungaro, MD

"Our finding that TNF antagonist therapy is not associated with severe COVID-19 is reassuring news in light of the large number of patients who require this therapy, currently the most commonly prescribed biologic therapy for IBD patients," says study co-author, Ryan Ungaro, MD, a gastroenterologist with Mount Sinai Hospital's Feinstein IBD Center.

The researchers published their results in the peer-reviewed journal Gastroenterology.

"We have seen some signals emerge in the short term, but more nuanced questions about less commonly used medications or combinations of medications will require more time and larger numbers of reported cases," said Brenner.

Eric Benchimol MD, PhD, FRCPC

Already, SECURE-IBD is making an impression on practitioners, and impacting patient care. "SECURE-IBD has reassured us that the medications that we tend to use for patients with IBD don't seem to be putting them at an increased risk of bad outcomes," said Eric Benchimol MD, PhD, FRCPC, a pediatric gastroenterologist who chairs the Canadian Gastro-Intestinal Epidemiology Consortium, which conducts national research on IBD and other chronic illnesses. "That has helped us develop more informed guidance for patients."

Benchimol uses data from SECURE-IBD to group his patients into low risk, middle risk, and high risk categories. If his patients are on steroids or have severely active disease, he tells them they are at high risk of severe COVID-19 disease and should be extra careful. But if they are on biologics and their disease is in remission, he tells them they might consider going back to school or work. Provided, of course, that they continue to socially distance, wash their hands, and wear a mask.

"It has changed how I treat patients," says Benchimol. "If I can do anything to avoid steroids and start a biologic instead, I do."

Shortly after COVID-19 arrived in New Haven, Burris met with her gastroenterologist to talk about her options. When they first consulted SECURE-IBD, there were only one or two reports of individuals on her medication regimen, so they decided it was best for her to stay home. However, within a few weeks, similar cases began popping up in the database, all of which reported excellent outcomes. Using that data, they decided it was safe for Burris to return to work, at least for now.

"There is still so much to learn about COVID-19, but SECURE-IBD has given me confidence in my individual decision-making, helping me think clearly about risk to myself and to others in an undeniably emotionally charged situation," said Burris. "SECURE-IBD is global in scale but has made a huge difference in my individual life."

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