Abstract Details

Title Relapses Requiring Intravenous Steroid Use and Multiple Sclerosis (MS)-Related Hospitalizations: An Integrated Analysis of the BG-12 (Dimethyl Fumarate) Phase 3 Studies

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 121

Objective

Background BACKGROUND: MS relapses treated with IV steroids are often those which are more severe and have significant impact on functional ability. In the Phase 3 DEFINE and CONFIRM studies, dimethyl fumarate significantly reduced relapses over 2 years versus placebo.

Design/Methods DESIGN/METHODS: Patients aged 18-55 years with relapsing-remitting MS (McDonald criteria) and an Expanded Disability Status Scale score of 0-5.0 were recruited to both studies. Patients who received oral dimethyl fumarate 240 mg twice (BID) or three times daily (TID) or placebo were included in the integrated analysis, which was to be conducted only if baseline characteristics and treatment effects were homogeneous across the studies. Numbers of relapses requiring IV steroids and MS-related hospitalizations were tertiary endpoints in DEFINE and CONFIRM.

Results RESULTS: The integrated analysis included 769, 761, and 771 patients who received dimethyl fumarate BID, TID, and placebo, respectively. There were significantly fewer relapses requiring steroids and MS-related hospitalizations in both dimethyl fumarate groups, versus placebo. At 2 years, dimethyl fumarate reduced the annualized rate of relapses requiring IV steroids by 48% (BID; rate ratio, 0.52 [95% confidence interval, 0.43-0.64]) and 50% (TID; 0.50 [0.41-0.61]) versus placebo (both p<0.0001), and reduced the annualized rate of MS-related hospitalizations by 34% (BID; 0.66 [0.47-0.92]; p=0.0146) and 47% (TID; 0.53 [0.37-0.75]; p=0.0004).

Conclusions CONCLUSIONS: Dimethyl fumarate significantly reduced the number of relapses requiring IV steroids and MS-related hospitalizations, suggesting potential benefits in terms of reduced patient burden and health economic savings due to decreased resource utilization. These findings further support the efficacy results of DEFINE and CONFIRM.

Authors/Disclosures
Gavin Giovannoni, MD (QMUL) PRESENTER	Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. Dr. Giovannoni 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. Giovannoni 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. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.
James R. Couch, Jr., MD, PhD, FAAN (Univ of Oklahoma Health Sciences Ctr)	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.
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.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
Mariko Kita, MD (Virginia Mason Medical Center - Neurosciences Institute)	No disclosure on file
Minhua Yang	No disclosure on file
	No disclosure on file
Elisabetta Verdun Di Cantogno, MD (Merck Serono Int, SA)	Dr. Verdun Di Cantogno has received personal compensation for serving as an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA. Dr. Verdun Di Cantogno has stock in EMD Serono Research & Development Institute, Inc., Billerica, MA, USA.
Katherine T. Dawson, MD (Biogen)	No disclosure on file
Vissia Viglietta, MD	No disclosure on file
Sarah I. Sheikh, BM Bch, MSc, MRCP, FAAN	Dr. Sheikh has received personal compensation for serving as an employee of Takeda.
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.

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