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Abstract Details

Effect of Siponimod on Disability in EXPAND Re-examined with Two New Subscales of the Expanded Disability Status Scale in Patients with SPMS
Multiple Sclerosis
S5 - Multiple Sclerosis: Clinical Trials and Disease-modifying Therapy (2:24 PM-2:36 PM)
008
Evaluate treatment effects of siponimod on two different Expanded Disability Status Scale (EDSS) subscales in the EXPAND trial in patients with secondary progressive multiple sclerosis (SPMS).
In EXPAND, siponimod 2 mg/day reduced confirmed disability progression (as measured by EDSS) versus placebo over ≤36 months in patients with SPMS.
Two subscales were developed: Motor Integration (MI: ambulation, cerebellar/pyramidal functions) and Collateral (C: bowel and bladder, brainstem, cerebral, sensory and visual functions). Treatment differences (change from baseline in each subscale) were assessed using analysis of covariance mixed-effect model repeat-measurement model, with treatment, time point (and their interaction), country/region and baseline relapse status as factors, and corresponding baseline as covariates. Analyses were for all patients, patients with/without relapses during 24 months before enrollment and patients with/without gadolinium-enhancing lesions at baseline. Effect sizes (ES) were calculated for each time point. Analyses for hypothesis generation; no adjustment for multiple comparisons.
Data were analyzed for 1645 patients (siponimod, n=1099; placebo, n=546). Treatment effects were detected over 36 months for EDSS (p=0.020) and both subscales (MI: p=0.014; C: p=0.021); ES favoring siponimod were observed from 6 months onwards. MI subscale detected marked ES at Month 9 in all patients (0.12; p=0.007), the relapsing subgroup (0.25; p=0.009) and patients without lesions (0.13; p=0.012); and at Month 12 in those with lesions (0.22; p=0.041). Treatment effects were detected later with C subscale than with MI. The C subscale detected marked ES at Month 15 for the relapsing subgroup (0.19; p<0.05) and Month 27 for patients with (0.43; p<0.05) and without lesions (0.29; p<0.05).
Treatment effects were detected earlier in MI than C subscales. These findings are consistent with earlier EDSS subscale analyses of fingolimod data, and confirm the efficacy of siponimod on disability progression in patients with SPMS.
Authors/Disclosures
Gary R. Cutter, PhD (University of Alabama At Birmingham)
PRESENTER 		Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biodelivery Sciences International, Biogen, Click Therapeutics, Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein-Buendel Incorporated, Medimmune/Viela Bio, Medday, Merck/Serono, Neurogenesis LTD, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Recursion/Cerexis Pharmaceuticals, Regeneron, Reckover Pharmaceuticals, Roche, TG Therapeutics.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Applied Therapeutics, AI therapeutics, AMO Pharma, Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Green Valley Pharma, Horizon Pharmaceuticals, Immunic, Karuna Therapeutics, Mapi Pharmaceuticals LTD, Merck, Mitsubishi Tanabe Pharma Holdings, Opko Biologics,Prothena Biosciences, Novartis, Regeneron, Sanofi-Aventis, Reata Pharmaceuticals, NHLBI (Protocol Review Committee), University of Texas Southwestern, University of Pennsylvania, Visioneering Technologies, Inc.. Dr. Cutter has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Xiangyi Meng, PhD (Novartis) Dr. Meng has nothing to disclose.
Amit Bar-Or, MD, FRCPC (University of Pennsylvania) Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. The institution of Dr. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.
Ralph H. Benedict, PhD (University At Buffalo) Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Benedict has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Roche. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Benedict has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Benedict has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Benedict has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Brystal Mier Squibb. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Benedict has received research support from Genzyme. The institution of Dr. Benedict has received research support from Biogen. The institution of Dr. Benedict has received research support from Bristol Myer Squib. Dr. Benedict has received intellectual property interests from a discovery or technology relating to health care.
Stanley L. Cohan, MD, PhD, FAAN Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb (Celgene). Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Icometrix. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi genzyme. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche Genentech. Dr. Cohan has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Cohan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Cohan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Icometrix.
Nina Jaitly, MD (Novartis) No disclosure on file
Wendy Su, PhD No disclosure on file
Davorka Tomic Davorka Tomic has stock in Meck KGaA.
Bruce A. Cree, MD, PhD, MAS, FAAN (UCSF, Multiple Sclerosis Center) The institution of Dr. Cree has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. The institution of Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Autobahn. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Avotres. The institution of Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Cree has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Neuron23. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Boston Pharma. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Hexal/Sandoz. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kyverna. Dr. Cree has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. The institution of Dr. Cree has received research support from Genentech. The institution of Dr. Cree has received research support from Kyverna. Dr. Cree has received publishing royalties from a publication relating to health care.