Compared with biologic therapy, corticosteroid (steroid) use is associated with a nearly five-fold increase of venous thromboembolism in inflammatory bowel disease (IBD) patients, according to a new study1 in Clinical Gastroenterology and Hepatology, the official clinical practice journal of the American Gastroenterological Association. Venous thromboembolism is a condition that includes both deep vein thrombosis (a blood clot deep in the veins) and pulmonary embolism (a sudden blockage in a lung artery caused by a blood clot).
“We found that corticosteroid use — either alone or in combination with biologics — substantially increases the rate of venous thromboembolic events,” said lead study author Peter D.R. Higgins, MD, PhD, MSc, from the University of Michigan, Ann Arbor. “This was strikingly different from the patients who were on biologics alone, who had a significantly lower rate of events. Venous thromboembolism is common in IBD, and can lead to significant morbidity, increased death and high rates of recurrent blood clots. The importance of understanding what causes this complication in this patient group cannot be understated.”
Researchers conducted a retrospective analysis on adults with IBD identified from the Truven Health MarketScan® Databases. Over a 12-month follow-up period, researchers monitored 15,100 patients treated with biologics, corticosteroids or combination therapy (biologics and corticosteroids) for venous thromboembolic events. Three hundred twenty-five venous thromboembolic events occurred during the study period. The rates were 2.25 percent, 0.44 percent, and 2.49 percent for the corticosteroid only, biologic only and combination therapy groups, respectively.
“Combination therapy with corticosteroids and biologics was associated with nearly the same risk as corticosteroids alone, validating our conclusion that corticosteroids may truly increase venous thromboembolism risk, and eliminate the potential benefit (for venous thromboembolic events) of inducing remission with biologics alone,” added Dr. Higgins.
While the association between active IBD flares and venous thromboembolism has been well established, these results show for the first time a strong independent association between corticosteroid use and venous thromboembolism. A better understanding of the effects of corticosteroids on this complication of IBD may suggest a change in our therapeutic approach to severe inflammation in IBD.
Corticosteroids, also known as steroids, are often prescribed to IBD patients to reduce inflammation. Corticosteroids have a similar structure to estrogens, which are also associated with increased venous thromboembolism events.
This study was funded by AbbVie Inc.
1Higgins, Peter D.R., et al. Increased Risk of Venous Thromboembolic Events With Corticosteroid vs Biologic Therapy for Inflammatory Bowel Disease. Clinical Gastroenterology and Hepatology 2015: 13(2): 316-321, DOI: 10.1016/j.cgh.2014.07.017