Short- and medium-term safety profiles of anti-TNF therapies are well-established, but data on their long-term safety, especially beyond five years, remain limited. This study aims to compare the risk of adverse events (AEs) in patients on stable anti-TNF therapy for less than five years versus more than five years. A retrospective cohort study was conducted in an outpatient IBD clinic from April 2015 to November 2023. Patients were divided into short-term (less than five years) and long-term (more than five years) therapy groups. AEs were tracked across multiple systems, and time-adjusted risks were compared using multivariable Cox proportional hazards models. We identified 640 patients (785 instances) receiving stable anti-TNF therapy. A total of 82 AEs were reported over 1774 person-years. The AE incidence per 100 person-years was 5.12 in the short-term group and 3.50 in the long-term group with no significant adjusted risk between groups (aHR, 0.62; 95% CI 0.35 to 1.11). However, patients with CD on long-term infliximab therapy signaled a lower risk of AEs compared to short-term users (aHR, 0.33; 95% CI 0.11 to 1.00). Dermatologic events were the most common AEs. Long-term anti-TNF therapy appears to have a similar safety profile to short-term therapy, with no significant increase in overall AE risk. These findings may offer cautious reassurance regarding extended anti-TNF use, particularly in patients with CD on infliximab.
Roney et al. (Tue,) studied this question.