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OP024 Mucosal healing and dysplasia surveillance in a large referral Centre cohort of patients with Crohns disease and ulcerative colitis treated with vedolizumab

M. Noman1, M. Ferrante1, R. Bisschops1, G. De Hertogh2, K. Van Den Broeck1, K. Rans1, P. Rutgeerts1, S. Vermeire1, G. Van Assche*1

1UZ Leuven, Gastroenterology, Leuven, Belgium, 2UZ Leuven, Campus Gasthuisberg, Pathology, Leuven, Belgium

Background

Vedolizumab has been approved for the treatment of Crohn’s disease (CD) and ulcerative colitis (UC) based on controlled trials extending to one year. Long-term data on mucosal healing and on dysplasia surveillance in CD and UC are lacking. We aim to document the incidence of endoscopic disease activity and colonic dysplasia in CD and UC patients treated with vedolizumab maintenance therapy.

Methods

All patients recruited at a tertiary referral Centre in the open-label extension phase of the GEMINI studies (GEMINI long-term safety [LTS]) with at least 1 year of continued vedolizumab treatment, 300 mg IV on a 4 weekly dosing scheme, were analysed through retrospective electronic chart review. Endoscopic healing was defined as a Mayo score of 0 or 1 for UC. For CD, marked improvement in endoscopic lesions with persistent ulceration was defined as partial healing, and the absence of ulcers as complete healing. Regular surveillance endoscopy was prospectively scheduled for all UC and CD patients with longstanding colitis. Targeted biopsies were obtained at advanced imaging with Methylene blue or NBI (narrow band imaging) performed by expert IBD endoscopists. The same expert inflammatory bowel disease pathologist read all biopsies.

Results

Of 118 initially recruited patients in the GEMINI LTS study, 68 patients (29 CD/39 UC) received vedolizumab beyond 1 year. Median treatment duration was 38 (range 13–73) months. Endoscopy data were available for 23 CD and 34 UC patients. At the last colonoscopy, 70% of UC patients maintained mucosal healing. In CD, 44% had complete and 38% had partial healing. In a total of 32 (CD) and 50 (UC) colonoscopies throughout the study and performed after a median of 2.7 years, Mayo score 0 (UC) and complete healing (CD) was observed in 54% and 44%, respectively. Low-grade dysplasia (LGD) was detected in 10% of patients. No high-grade dysplasia (HGD) or colorectal cancer was found in biopsies or resected lesions, although HGD was found in the colectomy specimen of a refractory patient with LGD in biopsies.

Conclusion

Long-term endoscopic healing is observed in a selected group of CD and UC patients treated with vedolizumab. Although even larger cohorts are needed, no new colonic dysplasia signal was found in this study.