Adverse Events Associated with Advanced Therapy Compared with Conventional Therapy in Patients with Inflammatory Bowel Disease: A Common Data Model Analysis.

Abstract

Although clinical trials have reported adverse events (AEs) associated with advanced therapies (ATs) in patients with inflammatory bowel disease (IBD), the risks of AEs may be underestimated due to the selective nature of the study populations. This retrospective, observational study from 13 hospitals using a common data model compared the risks of AEs between patients receiving ATs and those not receiving ATs. Cox proportional hazards models and Kaplan-Meier analyses were conducted following propensity score matching. Patients with IBD receiving ATs exhibited a significantly higher risk of tuberculosis (hazard ratio [HR], 2.86; 95% confidence interval [CI], 1.77 to 4.63; p<0.001) and depression/anxiety (HR, 1.58; 95% CI, 1.15 to 2.16; p=0.005) than those not receiving ATs. In subgroup analyses, use of anti-tumor necrosis factor (anti-TNF) agents was associated with increased risks of tuberculosis (HR, 3.74; 95% CI, 2.12 to 6.59; p<0.001) and depression/anxiety (HR, 1.49; 95% CI, 1.07 to 2.09; p=0.019), but a lower risk of osteoporosis (HR, 0.38; 95% CI, 0.15 to 0.99; p=0.040). No significant differences were observed in herpes zoster or malignancy risk between AT and non-AT groups. Small-molecule agents were not associated with increased risks of tuberculosis, osteoporosis, depression/anxiety, or herpes zoster. The malignancy incidence was lower in the small-molecule group (HR, 0.26; p=0.013), although the number of events was small. ATs, particularly anti-TNF agents, were associated with an increased risk of tuberculosis and depression/anxiety in patients with IBD. Vigilant monitoring and management of potential AEs are crucial for optimizing treatment outcomes.