In patients with inflammatory bowel disease, neither biologics nor small molecule targeted therapies increase the risk for major adverse cardiac events, according to the largest study to address this question.
Biologics were associated with a reduced risk for both major adverse cardiac events (MACE) and venous thromboembolism (VTE) relative to no biologics. Small molecule therapies, such as Janus kinase (JAK) inhibitors, were associated with a neutral effect.
“Hopefully these data comfort us,” said investigator Miguel Regueiro, MD, the chair of the Digestive Disease & Surgery Institute at Cleveland Clinic, in Ohio.
Dr. Regueiro also expressed hope these data might change regulatory language. The FDA calls for JAK inhibitors to be used after a tumor necrosis factor (TNF) inhibitor due to safety concerns. This decision was based largely on a safety study conducted with the first-generation JAK inhibitor tofacitinib in older men with rheumatoid arthritis. The study led to a black box warning for these agents in most indications, but these new data challenge that association in IBD.