- Although time-released dimethyl fumarate (DMF; Tecfidera) and fingolimod (Gilenya) showed similar reductions in relapse rates and disability progression among individuals with relapsing-remitting multiple sclerosis (RRMS) in an indirect comparison study, patient-reported quality-of-life variables showed a preference for DMF.
Why this matters
- Head-to-head trials comparing of fingolimod and DMF have not been conducted.
- In matching-adjusted population, annualized relapse rate of DMF at year 2 was similar to fingolimod, with a rate ratio of 0.53 vs placebo for DMF (P<.0001 and vs placebo for fingolimod>
- There was a 31% reduction of risk for confirmed disability progression (CDP) for DMF vs placebo compard to a 24% reduction in risk for CDP for fingolimod vs placebo.
- Patient-reported outcomes significantly favored DMF in both the EuroQoL 5-Dimensions (EQ-5D) utility score (P=.0079) and the EQ-5D visual analog score (P=.0167).
- A matching-adjusted indirect comparison of delayed-release DMF and fingolimod accomplished by pooling individual patient data from the DMF DEFINE and CONFIRM trials and aggregate data from the fingolimod FREEDOMS and FREEDOMS II trials examining 2-y efficacy.
- Funding: Biogen, makers of Tecfidera.
- The 2-y trial duration may not sufficiently detect differences disability progression, which occurs gradually.