Abstract Details

Title Safety and Tolerability of Oral BG-12 (Dimethyl Fumarate) in Relapsing-Remitting Multiple Sclerosis (RRMS): Interim Results from ENDORSE Extension Study

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 162

Objective

Background BACKGROUND: BG-12 (dimethyl fumarate) demonstrated efficacy and safety in the 2-year Phase 3 studies, DEFINE and CONFIRM, in patients with RRMS.

Design/Methods DESIGN/METHODS: Patients previously randomized to dimethyl fumarate 240 mg twice (BID) or three times daily (TID) continued on the same dose in ENDORSE. Those randomized to placebo (PBO; both studies) or glatiramer acetate (GA; CONFIRM) were re-randomized 1:1 to dimethyl fumarate 240 mg BID or TID. Safety data including adverse events (AEs) were analyzed according to parent/extension study treatment received: BID/BID, TID/TID, PBO/BID, PBO/TID, GA/BID and GA/TID.

Results RESULTS: This analysis included 1,960 patient-years of follow-up. In the BID/BID and TID/TID groups (n=501 and 501), the incidence of AEs was 80% and 82%; serious AEs 10% and 12%; and discontinuations due to AEs 2% and 4%, respectively. In the PBO/BID, PBO/TID, GA/BID and GA/TID groups (n=249, 248, 118 and 119), the incidence of AEs was 85%, 84%, 75% and 79%; serious AEs 16%, 9%, 8% and 10%; and discontinuations due to AEs 14%, 15%, 10% and 22%, respectively. The most common AEs (?10% in any group) were MS relapse and nasopharyngitis for patients who continued on dimethyl fumarate, and flushing, MS relapse, nasopharyngitis, diarrhea, and upper abdominal pain for those previously treated with PBO or GA. Serious infection incidence was ?2% in each group. There were 14 malignancies (13 patients), diverse in type/location: six in patients who continued on dimethyl fumarate and eight in patients who switched to dimethyl fumarate. There were three deaths, none considered related to study drug.

Conclusions CONCLUSIONS: The safety profile of dimethyl fumarate in this interim safety analysis of ENDORSE is consistent with DEFINE and CONFIRM, with no new or worsening safety signals.

Authors/Disclosures
J. Theodore Phillips, MD, PhD, FAAN PRESENTER	No disclosure on file
Maria Alejandra Gonzalez Duarte, MD, FAAN (NYU Dysautonomia Center)	Dr. Gonzalez Duarte has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alnylam. Dr. Gonzalez Duarte has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Gonzalez Duarte has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alnylam . The institution of Dr. Gonzalez Duarte has received research support from Pfizer.
Robert J. Fox, MD, FAAN (Cleveland Clinic)	Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Immunic. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Siemens. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria Biologica. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InnoCare Pharma. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AB Science. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. The institution of Dr. Fox has received research support from National Institutes of Health. The institution of Dr. Fox has received research support from National MS Society. Dr. Fox has received publishing royalties from a publication relating to health care.
	No disclosure on file
Kartik Raghupathi	No disclosure on file
	No disclosure on file
	No disclosure on file
Mark Novas	No disclosure on file
Marianne T. Sweetser, MD, PhD (Alnylam Pharmaceuticals)	Dr. Sweetser has received personal compensation for serving as an employee of Alnylam Pharmaceuticals. Dr. Sweetser has received stock or an ownership interest from Alnylam Pharmaceuticals.
Vissia Viglietta, MD	No disclosure on file
Katherine T. Dawson, MD (Biogen)	No disclosure on file
Ralf Gold, MD (Neurologische Universitaetsklinik)	Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Gold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer Vital. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharamaceuticals. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Publishers. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Biogen. The institution of Dr. Gold has received research support from Novartis. The institution of Dr. Gold has received research support from Biogen.

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