Real World Treatment Persistence With Vedolizumab in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Abstract

Introduction: Vedolizumab (VDZ), a gut-selective monoclonal a4β7 integrin antibody, was approved in May 2014 to treat adult patients (pts) with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). Treatment (Tx) persistence can be considered a marker of effectiveness and tolerability. We conducted a systematic review and meta-analysis of published studies of real-world persistence with VDZ in pts with inflammatory bowel disease (IBD). Methods: MEDLINE-, Cochrane-, and Embase-indexed publications and relevant IBD conference proceedings from May 1, 2014, to June 22, 2017, were searched for reports of real-world VDZ persistence or discontinuation rates. Reports with n <10, pts < 18 y old or off-label VDZ use were excluded. A meta-analysis was conducted using the DerSimonian-Laird random-effects method to obtain a weighted mean (95% confidence interval) of VDZ Tx persistence for UC and CD at 6 months (mo) and 12 mo. If multiple reports were from the same cohort, the most recent cohort with the most pts was selected for the meta-analysis. Results for biologic-naive pt subcohorts were evaluated separately. Results: Sixteen studies were identified (mean age, range: UC 34-43 y, CD 37-47 y; mean disease duration: UC 3-9 y, CD 6-17 y; prior anti-tumor necrosis factor alpha exposure: UC 44%-100%, CD 71%-100%). VDZ persistence at 6 mo ranged from 64%-94% in UC pts (8 studies) and 64%-88% in CD pts (9 studies). At 12 mo, VDZ persistence rates ranged from 52%-88% in UC pts and 40%-74% in CD pts (6 studies each). In UC pts, pooled VDZ persistence rates were 75% and 72% at 6 mo and 12 mo, respectively (Fig. 1). In CD pts, pooled VDZ persistence rates were 75% and 61% at 6 mo and 12 mo, respectively (Fig. 2). Two studies reported higher rates of VDZ Tx persistence in biologic-naive subcohorts (UC: 81%-100%; CD: 79%-100%). Eight studies reported reasons for VDZ discontinuation; among patients who discontinued VDZ, the most common reason was lack of response (4 studies, range: 16%-82%); and adverse events led to discontinuation in 8%-17% of pts (4 studies).650_A Figure 1 No Caption available.650_B Figure 2 No Caption available.Conclusion: At 12 mo, approximately three-quarters and nearly two-thirds of UC and CD pts, respectively, persisted with VDZ Tx despite utilization in largely biologic-refractory pts. Higher VDZ Tx persistence was seen in pts naive to prior biologic therapy. Observed Tx persistence rates support long-term effectiveness and tolerability of VDZ in real-world settings.