PTH-116 Vedolizumab in the treatment of Crohn’s disease and ulcerative colitis – non-tertiary real world analysis

Introduction Vedolizumab is licenced for treatment of moderate-to-severe ulcerative colitis(UC) and Crohn’s disease(CD) after failure of conventional or anti-TNF therapy. Clinical trial data from the GEMINI studies reported a Wk 6 response rate of 47% in UC and 31% in CD and Wk 52 response rate of 42–57% (UC) and 39–44% (CD). Data from expert centres report a lower 12-month remission of 26–33%, with endoscopic mucosal healing of upto 63%. Prior anti-TNF exposure pts are likely to have a worse outcome.(VICTORY Study) Aims This single non tertiary study was designed to compare clinical, biochemical and endoscopic outcomes of Vedolizumab treatment in UC and CD. A secondary aim was to compare outcomes for anti-TNF naive v. anti-TNF exposed pts. Methods All IBD pts eligible for Vedolizumab at MDT review between 2016–2018 were included. Pts were grouped into anti-TNF naive and anti-TNF exposed, the severity of UC and CD classified by Simple colitis index or Harvey Bradshaw Index respectively, extent of disease defined by Montreal Classification. Baseline demographics, serum C-reactive protein, faecal calprotectin, colonoscopic severity (Mayo Endoscopic score and SES-CD) were recorded before starting Vedolizumab treatment and at 12 months. Standard definitions were used for clinical and endoscopic remission. Results 35 patients (20 UC,15 CD), M:F 21:14(UC13:7,CD8:7) were included. The mean age was 46.15y for UC (22–77) and 49.4y for CD (26–79). 15/20 UC patients and 12/15 CD patients were anti-TNF exposed. In the UC group: disease extent was E1=1,E2=5,and E3=14; mean SCAI 3.15, mean CRP =23 mg/L (range4–202), mean faecal calprotectin 616ug/g (range 4–1684), endoscopic severity mild = 4, moderate = 10, severe = 6. At 12 months, 9/15(60%) anti-TNF exposed and 2/5 anti TNF naive (40%) were in clinical remission, with endoscopic remission in 4 and 1 pt respectively. Mean CRP was 5 (4–7) and mean FCP 472. 1 pt developed a rash, 1 pt had abnormal LFT, and 2 failed to respond requiring surgery. In the CD group: mean Harvey Bradshaw score was 15 (0–30), mean CRP 15.7(4–202), FCP 250 (5–683). Disease extent was L1=2, L2=4 and L3=9. At 12 months 6/12 (50%) anti TNF exposed patients and 2/3(66%) anti TNF naive pts were in clinical remission with mean CRP 7.8(4–15) and FCP 472(4–1957). Conclusion In this real world study, we found that both UC and CD patients responded well to Vedolizumab treatment, with 50% TNF exposed pts achieving clinical remission, with 20–30% endoscopic healing rates. Although 20% pts needed surgery, we have shown efficacy of Vedolizumab in CD to be as good as UC, with a better outcome in anti TNF naive patients.