P671 Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands: a retrospective observational study

Abstract

Background: Randomised controlled trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn's disease (CD). Its use is increasing and data in the real-world setting is needed to inform future practice. Methods: A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across 7 UK hospitals between 1/11/14-30/11/16. The Health Research Authority approved the protocol (19/HRA/0008). Clinical disease activity was assessed at baseline, Week 14, 30 and 52 using the Harvey-Bradshaw Index (HBI) and partial Mayo Score (pMS). Clinical remission was defined as HBI ≤ 4 or pMS < 2 with a combined stool frequency and rectal bleeding subscore of ≤1. Clinical response was defined as ≥2 point decrease from baseline in pMS and ≥3 point decrease from baseline in HBI. The primary aim of this study was to describe corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers (C-reactive protein (CRP) and faecal calprotectin (FCP), concomitant drug use, mucosal healing, surgical intervention, hospital admissions and adverse effects. Results: 192 patients were included in the final analysis: 99 CD, 88 UC and 5 IBD unclassified (grouped with CD in this analysis). Forty-five per cent of UC and 10% of CD patients were anti-TNF naïve. Immunomodulator and corticosteroid use at baseline for UC and CD was 41%, 49%, 27% and 27%, respectively. The median age at exposure was 44 (range 18-79) years; 49% male and median BMI was 25.7 (range 15.3-44.6). Median exposure to vedolizumab was 38.4 (IQR 23.6-58.9) for UC and 31.0 (IQR 21.6-52.5) weeks for CD. Corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Clinical response rate for UC was 49% and CD was 53%. The median time to corticosteroid-free remission for UC and CD was 17.6 (IQR 8.7-29.6) and 15.7 (IQR 6.0-21.7) weeks and clinical remission was 15.1 (IQR 7.4-24.9) and 10.1 (IQR 3.1-21.0) weeks, respectively. Time to clinical response for UC was 9.4 (IQR 5.3-16.4) and CD was 9.5 (IQR 6.1-18.2) weeks. Median disease activity scores decreased from baseline to 14 weeks: pMS 5 (IQR 0-9) vs. 3 (IQR 0-9), HBI 7(IQR 0-15) vs. 5 (IQR 1-14). CRP and FCP normalisation occurred by 52 weeks in CD and 14 weeks in UC. The overall rate of IBD-related hospital admissions per patient per year was 1.3 (0-18). Adverse events were reported in 6% of patients. Conclusions: Results in our vedolizumab patient population, predominately anti-TNF experienced, mirror other published realworld data and demonstrate very good clinical effectiveness and comparable safety profile. Takeda UK Ltd. sponsored this study.