DX71
Patient-Reported Treatment Experience of Multiple Sclerosis Patients Receiving Delayed-Release Dimethyl Fumarate (DMF) from Specialty Pharmacy: Interim Results
While the clinical profile of delayed-release dimethyl fumarate (DMF) was established in the Phase 3 clinical trials, few data exist to understand patient treatment experience in the real world. In December 2013, a national specialty pharmacy began a 12-month study of multiple sclerosis (MS) patients starting DMF.
Objectives:
To assess treatment experience of MS patients treated with DMF in the areas of patient-reported medication tolerability, medication adherence, and disease-related outcomes.
Methods:
This observational study collects patient-reported endpoints including the incidence of adverse events and proportion of unresolved adverse events; as well as adherence at predefined intervals ( weeks 0,1,4,8,12,24,48,72,96) via clinician-administered telephonic surveys. As of 11/1/2014, 165 of 750 enrolled patients had completed endpoint collection at week 24.
Results: Interim Results as of 11/1/2014.
Tolerability: At the week 1, 4, 8, 12 and 24 assessments, 24%, 27%, 17%, 19% and 13% of patients reported unresolved adverse events, respectively. The most commonly reported adverse events include: flushing, stomach/GI upset, diarrhea and nausea. While most patients remained on therapy without modification, the rate of therapy modification (change in regimen) or discontinuation ranged from 1-7%. With the exception of the week 4 assessment, the combined therapy modification and discontinuation rate did not exceed 2% of patients. The most common management strategies by adverse event: 28% tried aspirin to control flushing, 25% tried antacid to control GI upset; 49% tried other remedy to control diarrhea, 30% tried an anti-emetic for nausea.
Adherence: Although 31% of patients reported missing at least one dose in the first 4 weeks of therapy, only 7% reported missing more than 2 doses.
Disease Related Outcomes: As of 11/1/2014, there were 5 patient-reported hospitalizations related to relapse. Regarding ambulation, 25%, 26%, 25% and 31% of patients reported requiring aid or assistance to walk or being unable to walk at weeks 4, 8, 12 and 24 respectively.
Conclusions: to be determined upon study completion
Study supported by Biogen.