Delayed-Release Dimethyl Fumarate in Relapsing Multiple Sclerosis after Suboptimal Response to Glatiramer Acetate: Respond 6-Month Interim Analysis
Objectives: Present 6-month interim analysis results for RESPOND, an observational study evaluating the effectiveness of DMF on clinical outcomes and PROs in MS patients who switched from GA to DMF after suboptimal response to GA in the real-world setting.
Methods: RESPOND (ClinicalTrials.gov identifier: NCT01903291) is an open-label, single-arm study in relapsing MS patients in the US. Eligibility criteria include age ≥18 years; ongoing treatment with and suboptimal response (eg, suboptimal efficacy, intolerance, or poor adherence) to GA or discontinuation of GA as a result of suboptimal response within 30 days of enrollment; pre-enrollment decision to initiate DMF; and had baseline assessments prior to start of DMF treatment. Relapse data are collected from medical records to assess clinical effectiveness over the 12-month study period. Patients complete the following PROs prior to initiation of DMF and at Months 6 and 12 after initiation of DMF: 14-item Treatment Satisfaction Questionnaire for Medication (TSQM-14), Short Form-36 (SF-36), Modified Fatigue Impact Scale (MFIS-5), Beck Depression Inventory (BDI-7), Work Productivity and Impairment Questionnaire: Multiple Sclerosis (WPAI-MS), Morisky 8-item Medication Adherence Scale (MMAS-8), and patient-reported Expanded Disability Status Scale (EDSS).
Results: As of 15 July 2014, RESPOND enrolled 226 patients (intent-to-treat) with a mean age of 47 (range: 18–73) years; 81% were female and 92% were White. Reasons for discontinuation of the most recent GA included efficacy reasons (45%), tolerability (43%), or safety (5%); lack of adherence (4%); and patient preference (41%); patients could indicate more than one reason for discontinuation. RESPOND is ongoing; results of the 6-month interim analysis will be presented.
Conclusions: RESPOND is being conducted to examine the effectiveness of DMF in relapsing MS patients after suboptimal response to GA.
Study supported by: Biogen.