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Abstract Details

Improvement in Cognitive Processing Speed With Ofatumumab in Patients With Relapsing Multiple Sclerosis
Multiple Sclerosis
P6 - Poster Session 6 (5:30 PM-6:30 PM)
3-005
In the phase 3 ASCLEPIOS I/II (NCT02792218/NCT02792231) trials, ofatumumab significantly reduced inflammatory disease activity and relapses, as well as delayed disability worsening, in patients with relapsing multiple sclerosis (RMS).
To examine the effect of ofatumumab on cognitive processing speed (CPS). 
We analyzed the change in Symbol Digit Modalities Test (SDMT) score (baseline to Month 24; derived from a mixed model for repeated measures), proportion of patients with ≥4-point sustained improvement on SDMT (by categorical analysis), and time to first 6-month confirmed cognitive improvement (6mCCI; ≥4-point improvement on SDMT) in the overall population and in a subgroup of recently diagnosed (RD; within the last 3 years) patients. Time to first 6mCCI was analyzed in a subgroup with/without (SDMT score ≤43 or >43) baseline cognitive impairment.
Ofatumumab significantly improved SDMT scores from baseline to Month 24 vs teriflunomide in both the overall (n=492 with ofatumumab; n=468 with teriflunomide; mean age, 38.2 years) and RD populations (n=245 with ofatumumab; n=238 with teriflunomide; mean age, 35.9 years). Mean (SE) SDMT change from baseline was 3.50 (0.358) with ofatumumab and 2.39 (0.365) with teriflunomide in the overall population (p=0.030); these values were 4.29 (0.489) and 2.56 (0.492), respectively, in the RD population (p=0.012). The percentage of patients with 4-point sustained SDMT improvement was 25.0% (233/946) with ofatumumab and 19.6% (180/936) with teriflunomide in the overall population (p=0.005); these values were 26.9% (118/443) and 20.2% (91/454), respectively, in the RD population (p=0.018). Ofatumumab numerically increased the probability of time to first 6mCCI (hazard ratio [95% CI]) in the overall population (1.14 [0.96-1.36]), RD subgroup (1.19 [0.93-1.52]), and patients without baseline cognitive impairment (1.23 [0.98-1.56]).
Ofatumumab was associated with more clinically meaningful improvements in CPS vs teriflunomide in both populations. Early initiation of ofatumumab may enhance CPS improvement in patients with RMS by suppressing inflammation.
Authors/Disclosures
Ralph H. Benedict, PhD (University At Buffalo)
PRESENTER
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.
Iris Katharina Penner, PhD (COGITO Center & Heinrich Heine University, Neurology Dept, Medical Faculty) The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Penner has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. The institution of Dr. Penner has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer. The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. The institution of Dr. Penner has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Penner has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Penner 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. Penner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene . Dr. Penner 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. Penner 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. Penner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Dr. Penner has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Gary R. Cutter, PhD (University of Alabama At Birmingham) 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.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel) The institution of Dr. Kappos has received research support from Bayer. The institution of Dr. Kappos has received research support from Biogen. The institution of Dr. Kappos has received research support from Genentech. The institution of Dr. Kappos has received research support from Genzyme. The institution of Dr. Kappos has received research support from Janssen. The institution of Dr. Kappos has received research support from Merck Serono. The institution of Dr. Kappos has received research support from Minoryx. The institution of Dr. Kappos has received research support from Novartis. The institution of Dr. Kappos has received research support from Roche. The institution of Dr. Kappos has received research support from Sanofi. The institution of Dr. Kappos has received research support from Santhera. The institution of Dr. Kappos has received research support from Swiss MS Society, Swiss National Research Foundation, European Union, Roche Research Foundation, Innosuisse. The institution of Dr. Kappos has received research support from Shionogi. The institution of Dr. Kappos has received research support from Japan Tobacco. The institution of Dr. Kappos has received research support from Auriga Vision AG. The institution of Dr. Kappos has received research support from EMD Serono. The institution of Dr. Kappos has received research support from Glaxo Smith Kline. The institution of Dr. Kappos has received research support from Wellmera AG. The institution of Dr. Kappos has received research support from Eli Lilly (Suisse) SA. The institution of Dr. Kappos has received research support from Bristol Myers Squibb. The institution of Dr. Kappos has received research support from Celltrion Inc. Dr. Kappos has received intellectual property interests from a discovery or technology relating to health care.
Patricia K. Coyle, MD, FAAN (SUNY At Stony Brook) Dr. Coyle has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Accordant. Dr. Coyle has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Coyle has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Coyle has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Sanofi Genzyme. Dr. Coyle has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly and Company. Dr. Coyle has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Coyle has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for GlaxoSmithKline. Dr. Coyle has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon Therapeutics. Dr. Coyle has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LabCorp. Dr. Coyle has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Coyle has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Mylan. Dr. Coyle has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Coyle has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Coyle has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Coyle has received research support from CorEvitas LLC. The institution of Dr. Coyle has received research support from Genentech/Roche. The institution of Dr. Coyle has received research support from NINDS. The institution of Dr. Coyle has received research support from Sanofi Genzyme. The institution of Dr. Coyle has received research support from Celgene.
No disclosure on file
Amin Azmon No disclosure on file
Ibolya Boer Ibolya Boer has received personal compensation for serving as an employee of Novartis AG.
Wendy Su Prof. Su has received personal compensation for serving as an employee of Novartis. Prof. Su has received stock or an ownership interest from Novartis.
Jeffrey A. Cohen, MD (Cleveland Clinic) Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FiND. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for INMune. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sage.