Measuring Adherence of Tecfidera(R)

Background:

Tecfidera® is pending approval by the FDA as the first twice daily oral disease-modifying treatment for MS. Twice daily dosing for chronic medications has been well-studied and adherence has been shown to be between 50-80% . Cognitive and mood disorders are well-documented barriers to adherence, both common in Multiple Sclerosis. A study of adherence to twice a day therapy for Multiple Sclerosis treatment is needed to examine barriers to adherence and patterns of administration.

Objectives:

This is a 12-month, exploratory study measuring the adherence rate of twice-daily oral Tecfidera®. Secondary objectives will include the relationship between mood, quality of life and tolerability as related to adherence.

Methods:

Adherence will be measured using the Medication Event Monitoring System (MEMS) 6 monitor with LCD Display through the medAmigo web platform (attachment), as well as through pill counts performed on a monthly basis at site visit, or via phone. Questionnaires measuring quality of life (QOL) and symptoms will include the Multiple Sclerosis International Quality of Life (MusiQoL), Fatigue Severity Score (FSS), Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ), Tolerability and Treatment Satisfaction (TSQM) and Beck Depression Inventory (BDI) will be administered at baseline, Month 3, 6 and 12.

Results: in progress

Conclusions: in progress