Abstract Details

Title Improvement in Cognitive Processing Speed With Ofatumumab in Patients With Relapsing Multiple Sclerosis

Topic Multiple Sclerosis

Presentation(s) P6 - Poster Session 6 (5:30 PM-6:30 PM)

Poster/Presentation
Number 3-005

Objective To examine the effect of ofatumumab on cognitive processing speed (CPS).

Background 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).

Design/Methods 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.

Results 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]).

Conclusions 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 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 $10,000-$49,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Benedict has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic Therapeutics. 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 $50,000-$99,999 for serving as a Consultant for onsulting or Advisory Boards: Alexion, Antisense Therapeutics/Percheron, Avotres, Biogen, Clene Nanomedicine, Clinical Trial Solutions LLC, Endra Life Sciences, Cognito Therapeutics, Genzyme, Genentech, Immunic, Klein-Buendel Incorporated, Kyverna Therapeutics, Inc. , Linical, Merck/Serono, Noema, Neurogenesis, Perception Neurosciences, Protalix Biotherapeutics, Regeneron, Revelstone Consulting, Roche, SAB Biotherapeutics, Sapience Therapeutics, Scott&Scott LLP, Tenmile.. Dr. Cutter has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Argenx, Astra-Zeneca, Avexis Pharmaceuticals, Bristol Meyers Squibb, CSL Behring, Cynata Therapeutics, DiamedicaTherapeutics, Horizon Pharmaceuticals, Immunic, Inhibrix, Karuna Therapeutics, Kezar Life Sciences, Medtronic, Merck, Meiji Seika Pharma, Mitsubishi Tanabe Pharma Holdings, Prothena Biosciences, Novartis, Pipeline Therapeutics (Contineum), Regeneron, Sanofi-Aventis, Teva Pharmaceuticals, United BioSource LLC, University of Texas Southwestern.. Dr. Cutter has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JASN.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
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 $500-$4,999 for serving as a Consultant for Amgen. 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 $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. 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 Cleveland Clinic.
	No disclosure on file
Amin Azmon	No disclosure on file
Ibolya Boer, MD	Ibolya Boer has received personal compensation for serving as an employee of Novartis AG.
Wendy Su (Novartis Pharmaceuticals Corporation)	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 Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 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 Viatris. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. 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.

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