Abstract Details

Title Systematic Literature Review and Mixed Treatments Comparison of BG-12 (Dimethyl Fumarate) and Disease Modifying Therapies for Relapsing-Remitting Multiple Sclerosis

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 127

Objective

Background BACKGROUND: Oral dimethyl fumarate has been studied in patients with RRMS in two Phase 3 trials (DEFINE and CONFIRM). Both studies were placebo-controlled, and CONFIRM included glatiramer acetate (GA) as a reference comparator. In the absence of direct comparative evidence, systematic review and mixed treatments comparison (MTC) analysis can provide insight into the relative efficacy, safety, tolerability, and quality of life of dimethyl fumarate compared with other therapies for RRMS.

Design/Methods DESIGN/METHODS: Systematic searches were conducted in MEDLINE®, Embase®, and the Cochrane Library to identify randomized controlled trials evaluating dimethyl fumarate, GA, interferons, natalizumab, and fingolimod. Conference proceedings from relevant annual symposia were also hand searched. Studies were included based on a pre-specified protocol and extracted by a team of reviewers and information scientist independently. The quality of included trials was assessed according to the criteria recommended by NICE (UK) and IQWiG (Germany) guidelines. MTC was conducted to derive the relative effect size for the included treatments using SAS® analytical software version 9.3.

Results RESULTS: Annualized relapse rate (ARR) was considered as the primary efficacy outcome. The results of MTC suggest that dimethyl fumarate 240 mg twice daily demonstrated statistically significant reduction in ARR compared to placebo, interferons, and GA. Compared with fingolimod, reduction in ARR did not reach statistical significance. Natalizumab was significantly better than dimethyl fumarate. For confirmed disability progression (sustained for 3 months) at 24 months and discontinuation due to any cause, dimethyl fumarate was statistically better than placebo.

Conclusions CONCLUSIONS: With an overall promising efficacy and safety profile compared to current therapies, dimethyl fumarate offers a valuable treatment option for patients with RRMS.

Authors/Disclosures
Michael Hutchinson, MD (St Vincent's University Hospital) PRESENTER	Dr. Hutchinson has nothing to disclose.
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.
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK)	Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Baris Deniz	No disclosure on file
Sujata Sarda, PhD (Biogen Idec)	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file

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