Systematic Literature Review of Real-World Effectiveness and Safety of Vedolizumab in Adult Ulcerative Colitis and Crohnʼs Disease Patients

Abstract

Introduction: Vedolizumab (VDZ), a gut-selective monoclonal anti-integrin antibody, is approved for the treatment of moderate-to-severely active Crohn's disease (CD) and ulcerative colitis (UC) in adults. This study was a systematic review of recently published reports describing real-world effectiveness and safety of VDZ to date. 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 VDZ outcomes. Reports for patients < 18 years of age or of off-label VDZ use were excluded. Results: 67 reports were identified (primarily conference abstracts) describing over 7,700 VDZ patients. The majority of VDZ-treated patients had prior exposure to ≥1 anti-tumour 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 clinician assessment. In UC, real-world clinical remission rates at week 14 ranged from 24-55% (6 studies). Three UC VDZ studies reported steroid-free clinical remission rates at week 14 ranging from 19-36%. In 3 UC studies not reporting clinical remission rates, marked reductions in disease activity scores (DAIs) from baseline at week 14 were observed. Mucosal healing was observed in 57-69% of patients in 4 UC studies (Table 1). In CD, real-world clinical remission rates at week 14 ranged from 14-38% (7 studies). Three CD studies reported steroid-free clinical remission rates between 19-31% at week 14. In 5 CD studies not reporting clinical remission rates, marked reductions in DAIs from baseline at week 14 were observed. Mucosal healing was observed in 17-63% of patients in 4 CD studies (Table 1). VDZ patients experiencing adverse events (AEs) ranged from 4-42% (15 studies); rates of infection ranged from 4-13% (8 studies). Two studies reported serious AEs in 7-8% of VDZ patients (2-10% of VDZ patients experienced a serious infection).Table 1: Proportion of Vedolizumab Patients with Mucosal Healing in Ulcerative Colitis and Crohn's DiseaseConclusion: Real-world clinical effectiveness and safety data for VDZ confirm treatment benefit and a favourable safety profile for moderate-to-severely active UC and CD in largely anti-TNF-refractory populations. Evidence from larger VDZ cohorts over longer periods are required, especially in patients naive to biologic therapy.