Vedolizumab (VDZ), a gut-selective monoclonal anti-integrin antibody, is approved for the treatment of moderately-to-severely active Crohn's disease (CD) and ulcerative colitis (UC) in adults. This study aimed to assess early real-world experience of VDZ in UC and CD patients in the United Kingdom. Clinical characteristics of VDZ patients and treatment persistence, a potential marker of treatment effectiveness1, are reported.Methods:
A retrospective case note review (5 centres) was conducted in adult (≥18 yr) UC and CD patients prescribed VDZ for ≥10 and ≥14 weeks, respectively, during June 2015 to June 2016. Patients for whom medical records were unavailable, had received VDZ as part of a randomized controlled trial or were unable to provide written consent (unless deceased) were excluded. VDZ treatment persistence was assessed using the recorded discontinuation date or the date of the last VDZ infusion before the discontinuation record +56 days, whichever was sooner. Clinical patient characteristics are described using summary statistics.Results:
A total of 112 VDZ patients (UC: 41%; CD: 59%) were included with a median (interquartile range) follow-up of 7.4 (5.7–9.9) months post-VDZ initiation (UC: 7.4 [5.6–10.2]; CD: 7.4 [5.7–9.4]); mean (standard deviation [SD]) age at initiation 42.4 (17.0) years (UC: 42.5 [18.0]; CD: 42.4 [16.4]), 63% female (UC: 50%; CD: 73%), mean (SD) disease duration of 11.7 (9.4) years (UC: 8.7 [9.2]; CD: 13.8 [8.9]). During 2-years pre-VDZ initiation, 47% (UC: 87%; CD: 20%) of patients had been treated with aminosalicylates, 73% (UC: 72%; CD: 74%) with immunomodulators, 76% (UC: 91%; CD: 65%) with corticosteroids and 71% (UC: 72%; CD: 71%) with a biologic (14% ≥2 biologics). In total, 16 (UC: n = 10; CD: n = 6) patients were biologic-naive at VDZ initiation. In the 60-day period prior to VDZ initiation, 15% (UC: 30%; CD: 5%) of patients had been treated with aminosalicylates, 30% (UC: 28%; CD: 30%) with immunomodulators, 39% (UC: 57%; CD: 27%) with corticosteroids and 34% (UC: 37%; CD: 32%) with a biologic. UC or CD-related surgery was performed in 0% and 14% (3% perianal procedures) of UC and CD patients, respectively, during the 12-month period pre-VDZ initiation. At the point of data collection, 89% and 80% of UC and CD patients, respectively, were still receiving VDZ; 91% of UC and 97% of CD patients received their first 3 VDZ infusions within 14 weeks of initiation (90% and 100% of biologic-naive UC and CD patients, respectively). Of UC (n = 31) and CD (n = 44) patients with ≥6 months of available follow-up post-VDZ initiation, 94% and 77% were persistent at 6 months, respectively; all (100%) biologic-naive patients with ≥6 months of follow-up were persistent at 6 months in UC (n = 5) and CD (n = 4) versus 92% and 75% of biologic-experienced patients, respectively.Conclusions:
Early real-world experience of VDZ in the United Kingdom confirm high rates of treatment persistence with VDZ in moderately-to-severely active UC and CD, in a largely treatment-refractory population. Higher rates of treatment persistence were reported in biologic-naive patients. Evidence from larger cohorts over longer periods are required to support these findings, especially in biologic-naive patients.