Biomarkers of methotrexate response in atopic eczema
Research type
Research Study
Full title
Pilot cohort study of methotrexate in atopic eczema to identify biomarkers that predict patient response
IRAS ID
179930
Contact name
Nick Reynolds
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Atopic eczema is a chronic disabling skin condition, associated with epidermal barrier dysfunction and cutaneous inflammation that often persists into adulthood. There is a significant unmet therapeutic need. We and others have demonstrated the efficacy of azathioprine (1)(2) and methotrexate(3,4) for refractory moderate-to-severe disease; however, ~30% of patients fail to respond and ~15% may withdraw because of side effects. Therefore, further studies are required to determine the relative efficacy of azathioprine and methotrexate and whether the therapeutic response of methotrexate/azathioprine may be stratified by clinical endotype or biomarkers.
The study aims to:
- test and develop molecular stratification biomarkers of methotrexate response in atopic eczema identified in our novel skin equivalent models- improve the understanding of the molecular pathogenesis of atopic eczema and its response to therapy
- develop disease and drug biomarkers that inform disease classification and treatment outcome prediction
- test the hypothesis that biomarkers identified in skin equivalent models are relevant to human skin disease
This basic science study will be offered to patients who undergo treatment with methotrexate as part of their standard care.Patients will receive methotrexate once weekly, according to standard clinical dosing (with folic acid 5mg once weekly): 10mg-week one, then 15mg-weekly, increased to 20mg-weekly, according to clinical response (lack of EASI50 response i.e. a reduction in disease activity of <50% of baseline) and absence of significant toxicity at 8 or 12 weeks. Patients will complete the study at 6 months but will continue on methotrexate (or not) according to routine clinical practice and assessment of clinical response and the development of any adverse events.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
15/NE/0208
Date of REC Opinion
29 Jul 2015
REC opinion
Further Information Favourable Opinion