Mucosal Healing in Ulcerative Colitis: Definition, Treatment Target and Clinical Endpoints, a project of the Biomarkers Consortium.

There is a clear unmet need for ulcerative colitis (UC) patients – only a quarter of UC patients achieve remission with present therapies. Currently, there is no standardized way that studies are conducted for UC, and each study is doing things slightly different, which makes the results hard to compare and slows drug development. The FNIH Biomarkers Consortium Mucosal Healing for UC Project will harmonize the ways in which UC studies are completed across industry and academia to find the best common practices and the best measurements that signify that patients are in remission. The results of this project will be made publicly available so that the larger GI community has access to the findings and can implement best practices in order to speed the development of new treatments for patients. FDA has encouraged the evaluation of histopathology in UC clinical trials to make the claim of “mucosal healing” (MH) as a treatment goal. However, there is no community consensus on the definition of MH. There are challenges to achieving a standardized assessment of histologic disease, including: heterogeneity in collection of mucosal biopsies from study to study, lack of validated histology scoring systems and absence of standards for definitions of histologic improvement. This slows UC drug development and limits treatment options for patients. A consortium-based approach bringing together academics, industry and non-profits is needed to define and standardize MH and correlate the measurement with long-term patient outcomes. This project will: develop the definition of MH that establishes the prognostic utility of this measurement, establish best practices for collecting data to validate these measures and provide the collective voice of the community to promote acceptance by health authorities.