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MARQUEE

 

MARQUEE Study: Does Mucosal Healing Matter for Clinically Quiescent Ulcerative Colitis?

PI: Mark Osterman

BACKGROUND:

There is increasing evidence that patients with ulcerative colitis (UC) have better long-term outcomes, including lower rates of disease flares and also lower rates of hospitalization and surgery, if their gut mucosa is healed.  However, no study so far has examined whether treating with medication to the point of mucosal healing irrespective of clinical symptoms is an effective or warranted strategy.  The purpose of the proposed study is to determine the proportion of UC patients in clinical remission with active mucosal disease on endoscopy and on histology during routine surveillance colonoscopy.  We plan to determine whether the endoscopic activity correlates with biopsy findings.  We will then use this information to calculate the risk of clinical disease flare in UC patients depending on their level of endoscopic and histological disease activity.  The overall goal is to use all of the above information to plan a large randomized trial in which patients with clinically inactive UC will either remain on 5-ASA medications or step-up to immunosuppressives to determine whether treating with medication to the point of mucosal healing leads to improved clinical outcomes in the long run.  We strongly suspect that achieving mucosal healing will lead to better health and quality of life in our UC patients.

PLAN:

After finalization of the study protocol the study will be piloted at 7-10 centers to iron out protocol issues. Once funding for a definite study can be secured the study will be offered to all interested CRA centers.

RELATED PUBLICATIONS:

Osterman MT. Mucosal healing in inflammatory bowel disease: a review. Journal of Clinical Gastroenterology 2013;47:212-21.

Interim Reports 2014