Pooled DEFINE and CONFIRM safety data are included in one poster presentation:
Interim Extension Study Safety Results
- Safety and Tolerability of BG-12 in Patients with Relapsing-Remitting Multiple Sclerosis: An Integrated Analysis of the Placebo-Controlled Studies was available for viewing on Thursday, Oct. 11 from 3:30-5:00 p.m. CEST
Positive interim safety data from ENDORSE, a dose-blind, multi-center, Phase 3 extension study evaluating the long-term safety and efficacy of dimethyl fumarate 240 mg BID and TID, will also be presented at the congress. At the time of analysis, 1,736 patients with RRMS who completed the DEFINE study or the CONFIRM study had been dosed in ENDORSE.
Patients who received two years of dimethyl fumarate in DEFINE and CONFIRM continued on the same dimethyl fumarate dose (BID or TID) in ENDORSE. Patients who had previously received placebo or GA (CONFIRM only) were randomized 1:1 to dimethyl fumarate 240 mg BID or TID.
At the time of analysis, more than half of the patients in ENDORSE had been followed for more than one year. Overall, the safety profile for those first exposed to dimethyl fumarate in ENDORSE was consistent with the safety results established in the DEFINE and CONFIRM studies. There were no new safety signals observed in patients who had previously been on dimethyl fumarate.
In ENDORSE, the incidence of serious infections was low (≤2%) in all treatment groups and there were no opportunistic infections. There was no increased risk of infection in patients treated long-term with dimethyl fumarate. The overall incidence of malignancies was low (<1%). The types and frequency of malignancies that were observed in the treatment groups were expected in the population under study, and no specific pattern of malignancies was observed.
These data are included in one poster presentation:
- Long-Term Safety and Tolerability of Oral BG-12 (Dimethyl Fumarate) in Relapsing-Remitting Multiple Sclerosis: Interim Results from ENDORSE will be available for viewing on Friday, Oct. 12 from 3:30-5:00 p.m. CEST (late-breaking news)
The data presented at ECTRIMS were included in Biogen Idec’s regulatory submissions for dimethyl fumarate around the world.