Reasons for Discontinuation of Immunosuppression in Myasthenia Gravis
Research type
Research Study
Full title
A retrospective review of side effects and reasons for discontinuation of immunosuppressive agents in myasthenia gravis
IRAS ID
275802
Contact name
Katherine Dodd
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
There is limited evidence for choice of steroid-sparing agent for individuals with MG. Most adverse event data comes from patients with other conditions, such as inflammatory bowel disease. It is therefore unclear which drug would be most suited to which patients with MG, above the requirements of women of childbearing potential.
This study aims to examine time to discontinuation and reason for discontinuation of different immunosuppressive agents used for myasthenia gravis (MG). We plan to collect data on side effects of these medications, and explore whether clinical characteristics ((gender, age, duration of disease, co-morbidities) of patients relate to their tolerability.
For this large retrospective study of immunosuppressive agent use in the UK we plan to engage with the population of Myaware, the UK’s MG charity, to identify patients who have been treated with immunosuppressive agents. An initial online survey will question patients with MG about the immunosuppressant treatments they have been on and the side effects encountered.
Those who have clinical records at one of 11 involved centres, will then have their medical records reviewed to verify the information and for a more detailed analysis of their immunosuppression history. Initial information about duration of use of the medication, side effects, and reason for discontinuation will be collected by questionnaire and corroborated by reviewing the patients’ clinical notes.
Comparison will be made of failure rates between different immunosuppressive agents, and reasons for failure with different patient characteristics to see if there are correlations. This would provide data that would assist in the selection of a first line immunosuppressant drug in an individual patient. We aim to screen around 200 patients nationwide in the detailed analysis of drug discontinuation, and around 500 in the general survey of side effects.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0258
Date of REC Opinion
22 Nov 2021
REC opinion
Further Information Favourable Opinion