Updates From SECURE-IBD Shed Light on IBD Risks

A deeper dive into the data entered into the international Surveillance Epidemiology of Coronavirus Under Research Exclusion (SECURE-IBD) registry shows that patients with inflammatory bowel disease (IBD) who are treated with thiopurine monotherapy or with a combination of anti-tumor necrosis factor (TNF) therapeutics and thiopurines are at higher risk of developing a severe course of COVID-19. Michael Kappelman, MD, reported the latest findings at the Advances in Inflammatory Bowel Diseases 2020 virtual meeting on Thursday, December 10.

Dr Kappelman is a pediatric gastroenterologist and clinical epidemiologist at the University of North Carolina at Chapel Hill and has participated in creating SECURE-IBD and analyzing its data.

He explained that SECURE-IBD was designed to “rapidly define the impact of COVID-19 on patients with IBD and evaluate how factors such as age, comorbidities, and IBD treatments affect coronavirus outcomes, and to provide regular updates to the IBD community to inform care during the pandemic.”

Health care providers for patients with IBD fill out a web-based survey that includes data on patient locations, demographics, IBD characteristics, comorbidities, and COVID-19 outcomes, he noted. All data are deidentified in accordance with HIPAA Safe Harbor standards.

Through its website, SECURE-IBD enables sharing of real-time data and links to resources for patients and providers. As of October 13, 2020, 2156 cases have been reported to the database from 56 countries and 46 US states. Of these cases, 24% have required hospitalization with a mean length of stay of 10.3 days; 5% of these patients have been admitted to intensive care; 4% required mechanical ventilation; and 3% have died. The combination of statistics on intensive care, ventilation, and death yields a 6% rate of severe COVID-19. The majority of deaths occurred among patients aged 60 years or older and among patients with 2 or more comorbidities.

While the initial analyses indicated that only patients being treated with corticosteroids appeared to be at higher risk of a severe course of COVID-19, the latest information has shed new light on risks associated with the various therapeutics used in the management of IBD. Dr Kappelman and colleagues recently published an analysis of 1439 cases in 47 countries, in which the mean age of patients was 44 years and 51.4% of patients were men.

This analysis revealed that more than 9% of patients treated with a combination anti-TNF and thiopurine, or thiopurine monotherapy, had severe COVID-19 as defined by SECURE-IBD. Only 2% of patients being treated for IBD with anti-TNF monotherapy had a severe course of COVID-19.

Patients being treated with mesalamine or sulfasalazine monotherapy had an odds ratio of 3.52 for a severe course of COVID-19, while those on combination therapy of mesalamine with an anti-TNF agent had an odds ratio of 2.34.

This analysis found that patients treated with anti-interleukin 12/23 or anti-integrin biologics were at no significant increased risk of severe COVID-19 when compared with patients receiving anti-TNF monotherapy. The number of patients being treated with tofacitinib was too low to allow for more than a descriptive analysis, but to date, Dr Kappelman said, “there is no clear signal for a difference in outcomes but further data are needed.”

Dr Kappelman said, “the treatment of IBD has always involved balancing benefits and harms of treatment and of the disease itself. COVID-19 plays a minor in my balancing of benefits and risks,” and should play a minor role, as well, in decisions about whether a patient should return to school or work.

In applying these data to the care of patients, Dr Kappelman said, he minimizes corticosteroids but states there is “no absolute contraindication.” Further, he explained, “I do not avoid 5-ASAs in patients where this treatment has proven benefit,” such as patients with ulcerative colitis that is in remission, “but it should be minimized or stopped in situations where it has questionable utility,” as with patients who have Crohn disease or are being treated with an anti-TNF therapy.

“COVID-19 is perhaps another reason to favor anti-TNFs over 6-MP or azathioprine,” Dr Kappelman said.

He concluded, “We have to adapt practice in accordance with emerging data.”

—Rebecca Mashaw

Reference:

Kappelman MD. Updates from the SECURE-IBD registry. Talk presented at: Advances in Inflammatory Bowel Diseases 2020 virtual meeting; December 10, 2020.