The UK vedolizumab real-life experience study in inflammatory bowel disease (VEST): patient characteristics, drug persistence and patient-centred outcomes.

BACKGROUND

VEST was a multi-centre study of real-world use of vedolizumab in inflammatory bowel disease (IBD) in routine practice in the United Kingdom.

OBJECTIVES

To describe real-world indications, effectiveness, patient-reported outcomes and safety.

DESIGN

Prospective observational cohort study at 22 centres.

METHODS

Patients receiving vedolizumab as part of standard care were included. Data were collected at infusion visits for activity indices (Harvey-Bradshaw Index (HBI) or partial Mayo Score (PMS)), physician global assessment (PGA), patient-reported quality-of-life and treatment perception (IBD-Control Questionnaire) and adverse events. Clinical response (Wk14) was defined as a reduction in HBI ⩾3 or PMS ⩾2, clinical remission as HBI ⩽4 or PMS ⩽1 and analysed using non-responder imputation. One-year persistence was defined as continuing on vedolizumab after an infusion at ⩾48 weeks. Biomarker and endoscopic data were not available.

RESULTS

364 patients, mean age: 48 years; 132 (36%) with Crohn's disease (CD), 224 (62%) with UC and 8 (2%) with IBD-U; 174 (48%) male; 142 (39%) receiving steroids at baseline (Wk0); 141 (39%) bio-naïve. At baseline, 279 (77%) had "active" disease. One-year persistence: 58% overall (54% for active disease). Among persistent cases (n = 212), median (IQR) IBD-Control-8 scores improved from 6 (3-10) at baseline to 14 (10-16) at post-induction (Wk14) and 1 year (p < 0.001 vs baseline). Corresponding scores for IBD-Control-VAS were: 50 (30-70), 80 (65-90) and 85 (70-95), respectively (p < 0.001 vs baseline). Each domain of IBD-Control-8 showed improvement. Baseline and post-induction health status (activity index, PGA or IBD-Control) were associated with 1-year persistence, but no significant associations were observed for disease type, duration, bio-naïve status or baseline steroids. Of those with active disease at Wk0, clinical remission rates were 29%, 30% and 38% for CD, UC and IBD-U, respectively, and steroid-free remission rates were 26%, 27% and 38%. Similar remission rates were observed at 1 year. Possible adverse events leading to treatment cessation were rare (3%).

CONCLUSION

In routine clinical practice in the UK, vedolizumab demonstrated high levels of persistence. Similar rates of clinical response, remission and 1-year persistence were seen in UC and CD patients, and in bio-experienced versus naïve cases. Persistent cases experienced significant and sustained improvements in quality of life and treatment perception. Persistence does not imply anti-inflammatory efficacy, as biomarker data were not available.