S0861 Comparative Risk of Serious Infections With Tumor Necrosis Factor-α Antagonists vs Vedolizumab in Patients With Inflammatory Bowel Diseases

Abstract

INTRODUCTION: Comparative safety of therapies is an important attribute in choosing optimal therapy in patients with inflammatory bowel diseases (IBD). We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-α (TNFα) antagonists and those treated with vedolizumab. METHODS: Using an administrative claims database (OptumLabs Data Warehouse) we identified patients with IBD who were new-users of either TNFα antagonists or vedolizumab between 2014 and 2019 and had insurance coverage for at least 1y before and 1y after treatment initiation. We compared the risk of serious infections between patients treated with TNFα antagonists and those treated with vedolizumab using marginal structural Cox proportional hazard models adjusted for ulcerative colitis (UC) versus Crohn’s disease (CD), baseline demographics, healthcare utilization, comorbidities and time-varying use of IBD-related medications including corticosteroids and immunomodulators. RESULTS: We included 4896 patients treated with TNFα antagonists (age, 41 ± 15 y, 51% male, 60% with CD) of whom 434 developed serious infections over a 6009 person-year [py] follow-up, and 1106 patients treated with vedolizumab (age, 44 ± 16 y, 49% male, 39% with CD) of whom 86 developed serious infections over a 1077 py follow-up. On adjusted analysis, TNFα antagonists were associated with 2.4-fold higher risk of serious infections (hazard ratio [HR], 2.38 [95% CI, 1.38–4.13]) when compared with vedolizumab in all patients with IBD, and in subgroup analyses of patients with CD (HR, 2.28 [1.13–4.62]) and UC (HR, 1.62 [1.03–2.5]). This was primarily driven by increased risk of extra-intestinal serious infections (HR, 3.13 [1.48–6.63]), without any increase in risk of serious gastrointestinal infections (HR, 0.60 [0.33–1.08]). CONCLUSION: In a large claims-based study, TNFα antagonists were associated with increased risk of serious infections as compared with vedolizumab, in patients with CD and UC, particularly risk of extra-intestinal infections.