Ofatumumab Reduces Disability Progression Independent of Relapse Activity in Patients with Relapsing Multiple Sclerosis (1845)

Objective: To assess the effect of ofatumumab versus teriflunomide on confirmed disability Progression Independent of Relapse Activity (PIRA). Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody with a monthly low-dose (20 mg, s.c.) regimen, showed superior efficacy versus teriflunomide in the Phase 3 ASCLEPIOS I and II trials in relapsing multiple sclerosis (RMS) patients. As RMS patients acquire disability due to incomplete recovery from relapses or through gradual disability progression, it is important to characterize treatment effect on PIRA. Design/Methods: In this pooled analysis of the ASCLEPIOS I and II trials, the risk of disability progression confirmed at 3-/6-months (3mCDP/6mCDP: Expanded Disability Status Scale [EDSS] score increase of ≥1.0 if baseline EDSS score Results: Ofatumumab significantly reduced the risk of 3mCDP and 6mCDP (vs. teriflunomide) in all subsets analyzed except for 6mCDP in Subset-C: Subset-A by 41.3% (HR [95%CI]: 0.587 [0.407–0.848], p=0.004) and 36.8% (0.632 [0.421–0.947], p=0.026); Subset-B by 48.4% (0.516 [0.365–0.729], p Conclusions: When compared with teriflunomide, ofatumumab markedly reduced disability progression independent of relapses in a RMS population. Disclosure: Dr. Montalban has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Alexion, Biogen, Celgene, EMD Serono, Genentech, Genzyme, Hoffmann-La Roche, Immunic AG, Medday, Medscape, Merck, Mylan, Nervgen, Novartis, Sanofi-Genzyme, Teva Pharmaceutical and TG Therapeutics. Dr. Montalban has received research support from Abbvie, Biogen, Hoffmann-La Roche, Medday, Merck, Novartis, Sanofi-Genzyme and Teva Pharmaceutical.Yes Consulting: Convelo, Population Council; Speaking: Mylan Yes Editor, Multiple Sclerosis Journal.Dr. Comi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with honoraria for consultancy and/or speaking activities from Almirall, Biogen, Bayer, Chugai, Genzyme, Merck Serono, Novartis, Roche, Receptos, Sanofi, Serono Symposia International Foundation, and Teva.. Dr. Comi has received personal compensation in an editorial capacity for Clinical Investigation; European Journal of Neurology and Multiple Sclerosis; Neurological Sciences. Yes; Accordant, Alexion, Bayer, Biogen MA, Inc., Celgene Corporation, Genentech/Roche, Genzyme/Sanofi, GlaxoSmithKline, Novartis Pharmaceuticals Corporation, Serono, TG Therapeutics Yes; Actelion, Alkermes, Corrona LLD, Genentech/Roche, MedDay, NINDS, Novartis Pharmaceuticals Corporation, PCORIDr. Kappos has received research support from Bayer, Biogen, Innosuisse, Novartis, the Swiss MS Society, the Swiss National Research Foundation, and the European Union.Employee of NovartisDr. Sfikas has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Novartis. Employee of NovartisDr. Haering has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis.Employee of NovartisDr. Hauser has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alector, Annexon, Bionure, Molecular Stethoscope, Symbiotix. Dr. Hauser has received compensation for serving on the Board of Directors of Neurona. Dr. Hauser has received research support from F. Hoffmann-La Roche Ltd, and Novartis.