Comparative Safety and Effectiveness of Biologic Therapy for Crohn’s Disease: A CA-IBD Cohort Study

Background & AimsWe compared the safety and effectiveness of tumor necrosis factor α (TNF-α) antagonists vs vedolizumab vs ustekinumab in patients with Crohn’s disease (CD) in a multicenter cohort (CA-IBD).MethodsWe created an electronic health record–based cohort of adult patients with CD who were initiating a new biologic agent (TNF-α antagonists, ustekinumab, vedolizumab) from 5 health systems in California between 2010 and 2017. We compared the risk of serious infections (safety) and all-cause hospitalization and inflammatory bowel disease–related surgery (effectiveness) between different biologic classes using propensity score (PS) matching.ResultsAs compared with TNF-α antagonists (n = 1030), 2:1 PS-matched, ustekinumab-treated patients with CD (n = 515) experienced a lower risk of serious infections (hazard ratio [HR], 0.36; 95% CI, 0.20–0.64), without any difference in the risk of hospitalization (HR, 0.99; 95% CI, 0.89–1.21) or surgery (HR, 1.08; 95% CI, 0.69–1.70). Compared with vedolizumab (n = 221), 1:1 PS-matched, ustekinumab-treated patients with CD (n = 221) experienced a lower risk of serious infections (HR, 0.20; 95% CI, 0.07–0.60), without significant differences in risk of hospitalization (HR, 0.76; 95% CI, 0.54–1.07) or surgery (HR, 1.42; 95% CI, 0.54–3.72). Compared with TNF-α antagonists (n = 442), 2:1 PS-matched, vedolizumab-treated patients with CD (n = 221) had a similar risk of serious infections (HR, 1.53; 95% CI, 0.84–2.78), hospitalization (HR, 1.32; 95% CI, 0.98–1.77), and surgery (HR, 0.63; 95% CI, 0.27–1.47). High comorbidity burden, concomitant opiate use, and prior hospitalization were associated with serious infections and hospitalization in biologic-treated patients with CD.ConclusionIn a multicenter cohort of biologic-treated patients with CD, ustekinumab was associated with a lower risk of serious infections compared with TNF-α antagonists and vedolizumab, without any differences in risk of hospitalization or surgery. The risk of serious infections was similar for TNF-α antagonists vs vedolizumab. We compared the safety and effectiveness of tumor necrosis factor α (TNF-α) antagonists vs vedolizumab vs ustekinumab in patients with Crohn’s disease (CD) in a multicenter cohort (CA-IBD). We created an electronic health record–based cohort of adult patients with CD who were initiating a new biologic agent (TNF-α antagonists, ustekinumab, vedolizumab) from 5 health systems in California between 2010 and 2017. We compared the risk of serious infections (safety) and all-cause hospitalization and inflammatory bowel disease–related surgery (effectiveness) between different biologic classes using propensity score (PS) matching. As compared with TNF-α antagonists (n = 1030), 2:1 PS-matched, ustekinumab-treated patients with CD (n = 515) experienced a lower risk of serious infections (hazard ratio [HR], 0.36; 95% CI, 0.20–0.64), without any difference in the risk of hospitalization (HR, 0.99; 95% CI, 0.89–1.21) or surgery (HR, 1.08; 95% CI, 0.69–1.70). Compared with vedolizumab (n = 221), 1:1 PS-matched, ustekinumab-treated patients with CD (n = 221) experienced a lower risk of serious infections (HR, 0.20; 95% CI, 0.07–0.60), without significant differences in risk of hospitalization (HR, 0.76; 95% CI, 0.54–1.07) or surgery (HR, 1.42; 95% CI, 0.54–3.72). Compared with TNF-α antagonists (n = 442), 2:1 PS-matched, vedolizumab-treated patients with CD (n = 221) had a similar risk of serious infections (HR, 1.53; 95% CI, 0.84–2.78), hospitalization (HR, 1.32; 95% CI, 0.98–1.77), and surgery (HR, 0.63; 95% CI, 0.27–1.47). High comorbidity burden, concomitant opiate use, and prior hospitalization were associated with serious infections and hospitalization in biologic-treated patients with CD. In a multicenter cohort of biologic-treated patients with CD, ustekinumab was associated with a lower risk of serious infections compared with TNF-α antagonists and vedolizumab, without any differences in risk of hospitalization or surgery. The risk of serious infections was similar for TNF-α antagonists vs vedolizumab.