S0769 Comparative Evaluation of Treatment Outcomes in Patients With Crohn’s Disease Treated With Ustekinumab vs Vedolizumab

Abstract

INTRODUCTION: Ustekinumab (UST) and vedolizumab (VDZ) are approved biologic therapies for moderate-to-severe Crohn’s disease (CD). A prior US real-world study revealed significantly higher healthcare costs in patients (pts) receiving UST vs VDZ. This study compared treatment persistence, dose intensification, and opportunistic and serious infections as indicators of real-world effectiveness in CD pts receiving UST vs VDZ. METHODS: Adult pts with CD initiated on UST or VDZ (index drug) on or after Sept 26, 2016, with ≥6 months of continuous eligibility pre- and post-index date (index drug initiation) were identified using the IBM Truven Health Marketscan database (2009–2018). Treatment persistence was defined as time from index date to treatment discontinuation or end of follow-up. A sensitivity analysis evaluated treatment persistence from maintenance phase initiation. Time to dose intensification (defined as shortened dosing intervals, 1 shortened interval followed by treatment discontinuation or an extra infusion for UST) or end of follow-up was assessed. Time to a medical claim associated with an opportunistic infection or serious infection or end of follow-up was evaluated. Weighted Kaplan-Meier analyses were used to assess rates of events and log-rank tests were reported overall and in biologic-naïve pts (pts with no pre-index biologic therapy). Entropy balancing was used to address confounding factors. RESULTS: A total of 1188 CD pts were identified; 599 initiated UST (19.5% biologic-naïve) and 589 VDZ (29.2% biologic-naïve). Mean age was ∼44 years, 57% were females, 66% of pts used corticosteroids pre-index, and median follow-up was ∼14 months. Persistence from index date was similar with UST and VDZ overall (UST = 82.1%, VDZ = 76.5%; P = 0.17, at 12 months) and in biologic-naïve pts (UST = 87.0%, VDZ = 78.6%; P = 0.44, at 12 months; Table 1). Dose intensification was similar in UST and VDZ pts (UST = 32.7%, VDZ = 29.3%; P = 0.97, at 12 months) with a numerically higher difference in biologic-naïve pts (UST = 32.3%, VDZ = 21.5%; P = 0.43, at 12 months; Table 2). Rates of opportunistic (UST = 7.5%, VDZ = 8.7%; P = 0.57, at 12 months) and serious infection (UST = 6.3%, VDZ = 7.7%; P = 0.56, at 12 months)-related encounter were similar with UST and VDZ (Table 3). CONCLUSION: Although significantly higher real-world healthcare costs were previously shown to be associated with UST vs VDZ in CD pts, this study shows similar real-world clinical outcomes with these biologic therapies.Table 1.: Treatment Persistence. CI, confidence interval; pts, patients; UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan-MeierTable 2.: Rates of Dose Intensification. CI, confidence interval; pts, patients; UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan-MeierTable 3.: Rates of Opportunistic- and Serious Infection-Related Encounter. CI, confidence interval; pts, patients; UST, ustekinumab; VDZ, vedolizumab; WKM, weighted Kaplan-Meier