Vedolizumab (VDZ), a gut-selective monoclonal anti-α4β7-integrin antibody, is used for treatment of Crohn's disease (CD) and ulcerative colitis (UC). Examination of effectiveness in real-world clinical practice is important; however, cohorts are often small and heterogeneous. To overcome some of these shortcomings, we conducted a systematic review and meta-analysis on response, remission, and steroid-free remission outcomes at weeks 6 and 14 of treatment.Methods:
MEDLINE-, Cochrane-, and Embase-indexed publications and conference abstracts (n ≥10) were searched from 1 January 2014 to 27 May 2016 for studies reporting real-world VDZ effectiveness outcomes. 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 of response and remission rates.Results:
Sixty-seven published datasets were identified with 12 reporting response and/or remission rates on 945 (UC: n = 387; CD: n = 558) VDZ patients at week 6 and/or week 14. Amongst the included studies, the average age of patients ranged from 40 to 49 years, with median disease duration ranging from 2 to 11 years. Most VDZ-treated patients (∼92%) had prior exposure to ≥1 anti-tumor necrosis factor (TNF) therapy. Definitions of clinical remission 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 response and remission rates at week 6 were 43% (95% confidence interval [CI], 38%–49%) and 25% (11%–46%), respectively, and at week 14, 57% (51%–62%) and 33% (26%–41%), respectively. In CD, pooled clinical response and remission rates at week 6 were 60% (95% CI, 55%–65%) and 27% (17%–39%), respectively, and at week 14, 58% (52%–64%) and 27% (21%–35%), respectively. Pooled steroid-free remission rates at week 14 were 26% (16%–39%) and 23% (16%–33%) in UC and CD, respectively.Conclusions:
Pooled analysis of VDZ clinical response and remission across multiple studies confirm the effectiveness of VDZ in real-world clinical practice, with similar rates reported during induction for UC and CD. These results are broadly consistent with efficacy results from the phase 3 GEMINI clinical trials, despite the selection of complex patients failing previous biologic therapies. Further evidence on the effectiveness and safety of VDZ from large cohorts over longer periods are required, especially in patients naive to biologic therapy.