P466 Real world effectiveness of vedolizumab over one year in inflammatory bowel disease: a meta-analysis
Schreiber S.1, Dignass A.*2, Peyrin-Biroulet L.3, Hather G.4, Demuth D.5, Khalid J.M.6, Loftus E.V.7
1University Hospital Schleswig-Holstein, Institute for Clinical Molecular Biology, Kiel, Germany 2Agaplesion Markus Hospital, Department of Medicine 1, Frankfurt/Main, Germany 3Nancy University Hospital, Dpt. Gastroenterology, Vandoeuvre, France 4Takeda Development Center, Stats Innovation, Massachusetts, United Kingdom 5Takeda Development Center Europe Ltd, Evidence and Value Generation, London, United Kingdom 6Takeda Development Centre Europe Ltd, Evidence and Value Generation, London, United Kingdom 7Mayo Clinic College of Medicine, Gastroenterology and Hepatology, Minnesota, United Kingdom
A growing number of real-world studies document the effectiveness of Vedolizumab (VDZ), a gut-selective monoclonal anti-α4β7-integrin antibody approved for treatment of Crohn's disease (CD) and ulcerative colitis (UC). A systematic meta-analysis on clinical response, remission, and steroid-free remission real-world outcomes (6 and 14 weeks, 6 [26–30 weeks] and 12 months [46–54 weeks]) was conducted.
MEDLINE-, Cochrane-, Embase-indexed publications and conference abstracts (n≥10) were searched from 1 May 2014–31 October 2016 for studies reporting real-world VDZ effectiveness. Reports for patients <18 years of age or for 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) for each outcome.
A total of 98 studies were identified with 20 cohorts reporting response and/or remission rates on 1,714 (UC: 704; CD: 1,010) VDZ patients over a one-year treatment period. Amongst included studies, average age of patients ranged from 34 to 49 years and median disease duration ranged from 6 to 11 years. Most VDZ patients (≥71%) had prior exposure to ≥1 anti-tumour necrosis factor (TNF) therapy. Outcome measures included partial Mayo score, Simple Clinical Colitis Activity Index, Harvey-Bradshaw index, Crohn's Disease Activity Index and Physician Global Assessment. In UC, pooled clinical remission rates at week 14, 6 months and 12 months were 32%, 31% and 51%, respectively (Table 1). In CD, pooled clinical remission rates at week 14, 6 months and 12 months were 30%, 23% and 30%, respectively (Table 1). Pooled steroid-free remission rates at 6 and 12 months were 31% and 48%, respectively, in UC, and 23% and 25%, respectively, in CD (Table 1). The most common adverse events (AEs) reported were fatigue (<1–16%), arthralgia (<1–14%), fever (1–13%) and upper respiratory tract infections (1–14%); serious AEs occurred in 7–8% of VDZ patients.
Pooled real-world clinical response and remission rates and safety data support the positive benefit-risk profile of VDZ over at least one year. Results exceed efficacy reported from the GEMINI clinical trials, despite the selection of complex patients failing previous immunosuppressive or biologic therapies. Real-world data are an important supplement to randomized controlled trials; future studies should look to pool clinical outcomes in biologic-naive VDZ patients.