Shifts in Vedolizumab Utilization Across the United States Are Associated With Improved Outcomes

Abstract

Introduction: Early experiences after initial availability of drugs are impacted by use in high-risk or refractory patients waiting for alternative therapies (“warehouse effect”). This study aimed to compare treatment pattern and treatment outcomes with vedolizumab (VDZ) over time after launch. Methods: A time-trend analysis was performed with 2 data sets: 1) VICTORY consortium (n=1,087), a multicenter, tertiary referral center, collaborative cohort study for VDZ use in routine practice, and 2) Truven MarketScan Database (n=2,574), a nationally representative claims database. Time of VDZ treatment initiation was grouped into 2 periods: first 12 months of VDZ launch (Era 1; May 2014-June 2015), and subsequent 24 months (Era 2; July 2015-June 2017). Consortium outcomes assessed were 12-month cumulative rates for clinical remission (CREM; resolution of disease-related symptoms) and mucosal healing (MH; Mayo endoscopic subscore of 0 or 1 for ulcerative colitis [UC], absence of ulcers or erosions for Crohn's disease [CD]). Truven outcomes assessed were 12-month rates for inflammatory bowel disease (IBD)-related hospitalization and surgery. Results: Era 2 UC and CD patients were more often biologic naive in both VICTORY and Truven data sets (Table 1). In the VICTORY cohort, Era 2 CD patients had higher 12-month cumulative rates of CREM (40% vs 31%; P=0.03) and MH (58% vs 42%; PPP=0.006). This trend was not seen for CD in the Truven cohort for IBD-related hospitalization (16.6% vs 14.6%; P=0.46) or IBD-related surgery (16.8% vs 17.8%; P=0.71). Conclusion: There has been a shift in positioning of VDZ over the past 3 years toward using VDZ in less refractory patients, with a more pronounced shift toward early use in UC than in CD. This shift was accompanied by lower rates of IBD-related hospitalization and surgery for UC. For CD, although clinical practice data would suggest improved clinical outcomes over time, we did not observe a significant shift in IBD-related hospitalization or surgery. Further studies are needed to understand whether early VDZ use in CD impacts disease-related complications.583 Figure 1. Baseline Demographics