Exploring lymphopaenia in MS patients treated with dimethyl fumarate
Research type
Research Study
Full title
Exploring the rate, persistence and associations of lymphopenia in people with multiple sclerosis treated with dimethyl fumarate.
IRAS ID
269653
Contact name
Thomas Button
Contact email
Sponsor organisation
York Teaching Hospital NHS Foundaton Trust
Clinicaltrials.gov Identifier
000, 000
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Dimethyl fumarate is an immunomodulatory treatment with a long history of use in the treatment of psoriasis. It is licensed as a disease modifying therapy of relapsing-remitting multiple sclerosis. Very rarely progressive multifocal leukoencephalopathy, caused by a disabling and potentially fatal reactivation of JC virus, has resulted as complication of treatment with dimethyl fumarate. This has been associated with prolonged lymphopenia resulting from treatment. This study will involve a literature review to assess the strength of the association between prolonged lymphopenia and progressive multifocal leukoencephalopathy in people with multiple sclerosis treated with dimethyl fumarate.
Review of the records of people treated with dimethyl fumarate for multiple sclerosis in York, Hull and Leeds will allow the rate of lymphopenia and persistent lymphopenia to be assessed in a real-world cohort, together with its demographic and prior treatment associations.
Review of the records of the cohort consented to continue treatment will allow reporting of the relapse rate and disability progression in this group and for comparison with published natural history and treated controls.
An up to date literature review will allow an estimate of the risk of progressive multifocal leukoencephalopathy in the context of prolonged lymphopenia to properly inform consent of this group of patients. None to-date in Yorkshire and Humber have developed progressive multifocal leukoencephalopathy.
Review of the clinical data for this patient cohort will allow exploration of the proportion stopping treatment and their reasons.
The lymphocyte data for this group of patients can be used to review the frequency of safety monitoring required in long term treatment with dimethyl fumarate within the region.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
20/NE/0021
Date of REC Opinion
13 Feb 2020
REC opinion
Favourable Opinion