Assessing safety monitoring in patients taking oral multiple sclerosis treatments (ASYMPTOTE)

Project number: 
Approval date: 
Friday, May 6, 2016
Principal Investigator: 
University of British Columbia (UBC)
Funding Agency: 
Not Available
Datasets requested: 
Deaths (BC Vital Statistics Agency)
consolidation - census geocodes
Medical Services Plan (BC Ministry of Health)
Consolidation - demographic (Ministry of Health)
Hospital Separations (BC Ministry of Health)
Consolidation registry (Ministry of Health)
Research objective: 

Broad Study Aim: to assess the utilization and the safety of the new oral DMDs (fingolimod, dimethyl fumarate, teriflunomide) for MS, and examine adherence to the MS oral DMDs and the recommended laboratory tests.

Further Details:

In order to meet our broad study aim, the specific aims are to:

(1) Describe the uptake and use of the new oral DMDs in the general MS population;
(2) Describe the incidence, pattern and potential predictors of adverse events as indicated by laboratory monitoring results (i.e., lymphopenia, liver toxicity and proteinuria);
(3) Explore the incidence of cardiac arrhythmia, hypertension and pneumonia after initiation of the oral DMDs;
(4) Describe the adherence, and predictors of adherence, to these drugs;
(5) Explore the adherence to recommended laboratory testing in MS patients receiving the new oral DMDs and predictors of adherence to such monitoring. (This study aim which will not be conducted in British Columbia.)

Page last revised: March 12, 2018