The METHYLOMIC project will build on multiple previous cohort studies that confirmed epigenetic biomarkers (specifically DNA methylation) as the most stringent predictor of response to biological therapy, zooming in on CD. DNA methylation profiles in peripheral blood as biomarkers of response/deep remission for three approved biologicals in CD have been specifically discovered and validated. Through machine learning algorithms, treatment response could be predicted with up to 93% accuracy for each biological for CD and RA.
The project aims to bring personalised treatment selection in CD and other IMID to clinical practice. The project will look into research for further validation studies to develop a marketable rapid, targeted methylation assay that will then be validated in a unique prospective randomised clinical trial for CD. The efficiency and cost-effectiveness will also be assessed in great detail, and experts will guide regulatory approval to ensure delivery of the first epigenetic kit personalised treatment of CD.
The consortium comprises eighteen participants consisting of clinical, epigenetic, and DNA diagnostics experts, patient organisations, and companies across nine countries to ensure effective communication and commitment to help ease the challenges of patients with Crohn's disease.
EFCCA, as a partner, will play a role in launching multiple communication actions to boost the interest of patients and stimulate preparedness to participate by assessing and discussing research proposals and protocol and patient information form (PIF) from a patient perspective. EFCCA will also promote the research in patients with inflammatory bowel disease through the patient organisations in the countries where the research is taking place and announce the project results. The project will run for four years, and the kick-off meeting took place on 18 January in Amsterdam. The agenda discussed the project's background science and covered the communication and dissemination plans, project timelines, finances, and the future meeting structure.