The prime purpose of METHYLOMIC is to develop and clinically validate a novel epigenetic biomarker tool that enables the identification of most optimal treatments for individual patients and hence to ensure an effective and efficient use of existing and broadly prescribed biologicals for Crohn´s disease (CD). Thereby we will build on rapidly evolving DNA methylomics and machine learning technologies that tackle the hurdles currently encountered in the field. With close involvement of key-stakeholders and explorative studies in other chronic diseases (extrapolating our results to rheumatoid arthritis [RA] and the skin disease psoriasis [PsO]), we will push DNA methylation markers to become mainstream in clinical care in the next decades.
Why METHYLOMIC?
For Crohn’s disease
Crohn’s Disease (CD) is a leading cause of chronic discomfort and disability affecting up to 1 in 300 people in Europe and North America, particularly affecting young productive individuals (15-40 years). In the EU alone, 78.000 CD cases are diagnosed every year. Extrapolating these numbers for the total European population indicates that there may be up to 1.6 million persons with CD.
Biological therapy has been shown to induce and maintain remission in Crohn’s disease (CD) patients but their efficacy to induce remission does not exceed 30-40%. At present, we are unable to predict whether an individual CD patient will respond to a certain biological therapy, which results in random treatment selection. Because serious complications (abscess, perforation, stenosis, metabolic deficiencies) often occur during periods of ineffective treatment, this ‘trial and error’ approach is associated with unnecessary health costs and a major negative impact on the patient’s quality of life. CD patients are often young and professionally active. Hence, the impact of suboptimal treatment selection is enormous.
Seeking a solution
The researchers will now work with several companies and patient organizations to develop a rapid test. Furthermore, they will evaluate if the test works in clinical practise by performing a clinical trial with 378 Crohn’s disease patients. Based on methylation markers in a patient’s blood, it will be determined which treatment will work best for that patient and that specific therapy will then be started. For comparison, a group of identical patients will be treated in the normal way without using the test. This will help determine whether the test leads to more effective treatments. Similar data will also be collected from patients with rheumatoid arthritis or psoriasis so that the test can be developed for these patient groups as well in the future.
For Rheumatoid Arthritis
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For Psoriasis
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