Newly diagnosed patients with relapsing-remitting multiple sclerosis (RRMS) show significant improvements when treated with delayed-release dimethyl fumarate (DMF), especially in terms of reduction in confirmed disability progression. The study, “Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Multiple Sclerosis Using a Composite Measure of Disability,” was recently presented at the June 1-4 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
The results of the Phase 3 clinical trials DEFINE and CONFIRM showed that DMF had a significant effect in reducing confirmed disability progression in patients newly diagnosed with RRMS (measured using the Expanded Disability Status Scale, EDSS).
Now, a team of researchers hypothesized that using multiple neuroperformance components could potentially enhance confirmed disability progression assessment. Researchers determined the effect of DMF on multicomponent composite endpoints in newly diagnosed patients with RRMS from the DEFINE/CONFIRM clinical trials (newly diagnosed was defined as one year prior to study entry and treatment-naive, or previously treated with corticosteroids alone).
Patients with RRMS were randomly assigned to receive one of the following treatments – DMF 240 mg administered either two or three times a day, glatiramer acetate (this therapy was used at the CONFIRM trial only) or placebo. The total duration of treatment was for up to two years. The effects were measured at baseline and for 12-week intervals after the beginning of the treatments.
The study included 221 patients under DMF therapy and 223 patients in the placebo group. The team observed that DMF significantly reduced both the risk for 12-week and 24-week composite-confirmed disability progression, when compared to the placebo control group (assessed at the second year of treatment). The composite endpoint was measured by different methods, including the EDSS, Timed 25-Foot Walk (T25FW), Nine-Hole Peg Test (NHPT), or Paced Auditory Serial Addition Test (PASAT) or Visual Function Test (VFT).
Specifically, treatment with DMF resulted in a 32 percent and 44 percent reduction vs. placebo, for the 12-week and 24-week, respectively. A second composite-confirmed disability progression measure also showed significant benefits with DMF when compared to placebo, denoted by reductions of 44 percent and 45 percent at 12 and 24 weeks, respectively.
In conclusion, the results showed that DMF has significant benefits on a composite measure of disability progression when compared to placebo, in newly diagnosed patients with RRMS.
“These findings are consistent with previously published data suggesting the potential for greater clinical benefits in patients with RRMS who receive DMF treatment early in their disease course,” concluded the team in their presentation. “The composite CDP [confirmed disability progression] measure proposed here may be more reliable than assessing its individual components alone, capturing clinically meaningful changes in disability progression across multiple neuro-performance components.”
