Immunosuppressive Therapy for IBD Not Linked to Increased Risk of COVID-19

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Early studies of patients with COVID-19 suggested immunosuppression increases risk, but that conclusion was based on small numbers of patients receiving chemotherapy for malignancy or immunosuppression after organ transplantation.

In patients with inflammatory bowel disease (IBD), only a study of veterans (mostly older men) has evaluated the risk of disease related to drug exposure. Furthermore, it examined only exposure to thiopurines and tumor necrosis factor (TNF) inhibitors.

In a large retrospective study that addressed this gap in knowledge, published in Inflammatory Bowel Diseases, Kristin E. Burke, MD, MPH, inflammatory bowel disease physician in the Massachusetts General Hospital Crohn's and Colitis Center, Bharati Kochar, MD, MSCR, gastroenterologist in the Mass General Division of Gastroenterology, Ashwin N. Ananthakrishnan, MBBS, MPH, director of the Crohn's and Colitis Center, and colleagues found reassuring evidence that immunosuppressive therapy for IBD is not associated with increased risk of COVID-19.

Study Methods

The study included 5,302 adults with Crohn's disease or ulcerative colitis who were seen at Mass General or one of its partner hospitals between January 1, 2019, and April 25, 2020, and had at least one prescription for any of the following:

• Oral aminosalicylate (mesalamine, balsalazide, sulfasalazine)
• Immunomodulator (azathioprine, mercaptopurine, methotrexate)
• TNF inhibitor
• Other biologic (vedolizumab, ustekinumab, tofacitinib)
• Combination therapy (biologic plus immunomodulator)

Incidence of COVID-19

39 patients (0.7%) developed COVID-19, of whom seven were hospitalized. Three of those were admitted to the ICU and one died.

For context, in Massachusetts as of May 15, 2020, there had been 80,497 cases out of an estimated population of 6.9 million (infection rate 1.1%).

Influence of Medication

Overall, the COVID-19 rate was similar between patients treated or not treated with immunosuppression (0.64% vs. 0.8%; P=0.55). The frequency of COVID-19 among those on aminosalicylates was 0.64%, statistically similar to the 0.5% on immunomodulators, 1% on TNF inhibitor monotherapy and 1.2% on vedolizumab monotherapy.

Four COVID-19 cases occurred in patients on combination therapy versus none in those on ustekinumab or tofacitinib alone.

Prednisone use in the past year was not associated with the risk of COVID-19.

Predictors of COVID-19

On multivariable analysis adjusting for age, sex, race, IBD type and comorbidity, the only significant independent predictors of COVID-19 were a diagnosis of Crohn's disease or obesity.

Only older age and obesity were significantly associated with severe COVID-19.

Compared with no immunosuppression, the use of conventional immunomodulators, TNF inhibitors or vedolizumab was not associated with increased risk of COVID-19.

Clinical and Research Implications

These data support professional society recommendations that immunosuppression can be continued in patients with IBD during the COVID-19 pandemic. However, the study period fell during a time when most patients may have been self-isolating. Further study is necessary to examine the risk in subsequent phases of the pandemic.

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