Patients being treated with anti‐tumor necrosis factor‐alpha (anti‐TNFα) agents for non-inflammatory bowel disease (IBD) conditions may be at increased risk of developing Crohn disease (CD) or ulcerative colitis (UC), according to the results of a recently published cohort study.

While anti-TNFα agents have “revolutionized” the management of many chronic inflammatory conditions, these agents have also been associated with serious adverse effects, including the development of de novo autoimmune diseases. The aim of this Danish population-based study was to determine the association between anti-TNFα therapy and the risk of developing CD and UC. Using Danish health registries, the study authors analyzed the development of de novo IBD beginning in 2004 in patients who received at least 1 dose of an anti-TNFα agent for a non-IBD indication.

The authors identified a total of 17,018 patients with an autoimmune condition who had been exposed to an anti-TNFα agent and 63,308 patients with an autoimmune disease with no anti-TNFα exposure. The majority of the patients exposed had received infliximab, etanercept, or adalimumab

According to the results of the study, treatment with etanercept was found to be associated with an increased risk of developing de novo CD (adjusted HR: 2.0;  95% CI: 1.4, 2.8) and UC (adjusted HR: 2.0; 95% CI: 1.5, 2.8), while treatment with infliximab did not appear to increase the risk of de novo CD (adjusted HR: 1.3; 95% CI: 0.8, 2.2) or UC (adjusted HR: 1.0; 95% CI: 0.6, 1.6). Similarly, patients treated with adalimumab were not found to be at increased risk of developing de novo CD (adjusted HR: 1.2; 95% CI: 0.8, 1.8) or UC (adjusted HR: 0.6; 95% CI: 0.3, 1.0).  


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“This study firmly establishes the risk of developing de novo IBD while on anti‐TNFα agents, particularly with etanercept,” the study authors stated. They concluded, “This finding has relevance to clinical care and insights into common mechanisms of the pathophysiology of these diseases.”

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