Dimethyl fumarate works best when used first-line. #MSBlog #MSResearch
"The study below shows that dimethyl fumarate, or DMF, is more effective when used in MSers with early disease (<12 months since diagnosed) and who have not been treated with another DMT. The relapse reduction relative to placebo was 56-60%. The corollary of this that the subset left behind do worse; i.e. those who have a longer disease duration and who have failed a prior disease modifying therapy in the past. These results clearly position DMF as the most effective of the so called first-line DMTs and explains why the drug is doing so well were it has been launched."
"We still don't have it available in England; we need to wait for NICE and NHS England to green-light it for use. I note that it is already available in Scotland."
BACKGROUND: Delayed-release dimethyl fumarate (DMF) demonstrated efficacy and safety in the Phase 3 DEFINE and CONFIRM trials.
OBJECTIVE: To evaluate delayed-release DMF in newly diagnosed relapsing-remitting MSers, in a post-hoc analysis of integrated data from DEFINE and CONFIRM.
METHODS: MSers included in the analysis were diagnosed with RRMS within 1 year prior to study entry and naive to MS disease-modifying therapy.
RESULTS: The newly diagnosed population comprised 678 MSers treated with placebo (n = 223) or delayed-release DMF 240 mg BID (n = 221) or TID (n = 234). At 2 years, delayed-release DMF BID and TID reduced the annualized relapse rate by 56% and 60% (both p < 0.0001), risk of relapse by 54% and 57% (both p < 0.0001), and risk of 12-week confirmed disability progression by 71% (p < 0.0001) and 47% (p = 0.0085) versus placebo. In a subset of MSers (MRI cohort), delayed-release DMF BID and TID reduced the mean number of new or enlarging T2-hyperintense lesions by 80% and 81%, gadolinium-enhancing lesion activity by 92% and 92%, and mean number of new non-enhancing T1-hypointense lesions by 68% and 70% (all p < 0.0001 versus placebo). Flushing and gastrointestinal events were associated with delayed-release DMF.
CONCLUSION: Delayed-release DMF improved clinical and neuroradiological outcomes relative to placebo in newly diagnosed RRMSers.
CoI: multiple, I am a co-author on the paper and was a member of the DEFINE steering committee