2024 American Academy of Neurology Abstract Website

Gabriel Pardo¹, Stephen Hauser², Amit Bar-Or³, Ralf Gold⁴, Xavier Montalban⁵, Jeffrey Cohen⁶, Derrick Robertson⁷, Carrie Hersh⁸, Robert Naismith⁹, Kumaran Deiva¹⁰, Alit Bhatt¹¹, Haoyi Fu¹², Ibolya Boer¹³, Sven Meuth¹⁴, Anne Cross¹⁵, Jutta Gärtner¹⁶, Ludwig Kappos¹⁷
¹Oklahoma Medical Research Foundation, Oklahoma, USA, ²UCSF Weill Institute for Neurosciences, University of California, San Francisco, San Francisco, California, USA, ³Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, ⁴Department of Neurology, Katholisches Klinikum Bochum, Ruhr-Universität Bochum, Bochum, Germany, ⁵Department of Neurology Neuroimmunology, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d’Hebron, Barcelona, Spain, ⁶Department of Neurology, Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, USA, ⁷Multiple Sclerosis Division, Department of Neurology, University of South Florida, Tampa, Florida, USA, ⁸Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, United States, ⁹Department of Neurology, Washington University School of Medicine, Saint Louis, Missouri, USA, ¹⁰Department of Pediatric Neurology, University Hospitals Paris Saclay, Hôpital Bicêtre, National Reference Center for Rare Inflammatory Brain and Spinal Diseases, Le Kremlin Bicêtre, France, ¹¹Novartis Healthcare Pvt. Ltd., Hyderabad, India, ¹²Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, ¹³Novartis Pharma AG, Basel, Switzerland, ¹⁴Department of Neurology, Medical Faculty, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany, ¹⁵Department of Neurology, Section of Neuroimmunology, Washington University School of Medicine, Saint Louis, Missouri, USA, ¹⁶Department of Paediatrics and Adolescent Medicine, Division of Paediatric Neurology, University Medical Centre Göttingen, Georg August University Göttingen, Göttingen, Germany, ¹⁷Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) and MS Center, Departments of Head, Organs, Spine and Neuromedicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland

Objective:

To assess ofatumumab’s longer-term efficacy for up to 6 years in people with recently diagnosed treatment-naive (RDTN) relapsing multiple sclerosis (RMS).

Background:

Ofatumumab, a fully human anti-CD20 monoclonal antibody with a 20 mg subcutaneous monthly dosing regimen, demonstrated superior efficacy and similar safety versus teriflunomide in the Phase 3 ASCLEPIOS I/II overall population and in a subgroup of RDTN participants (diagnosed ≤3 years). Data from the ALITHIOS open-label extension study previously demonstrated sustained efficacy for up to 5 years in the overall and up to 4 years in the RDTN groups.

Design/Methods:

These analyses (data cut-off: 25-Sep-2022 [up to 5 years]/25-Sep-2023 [up to 6 years]) include cumulative data from the RDTN subgroups randomized to ofatumumab in the core (continuous group) and those originally randomized to teriflunomide and switching to ofatumumab in ALITHIOS (switch group).

Results:

The RDTN subgroup comprised 314/301 people in the continuous/switch groups (mean age at baseline: 36.8/35.7 years; 69.1%/65.8% female; mean EDSS: 2.30/2.28). In the 5-year analyses, the RDTN continuous group sustained a low annualized relapse rate (ARR) over Years 1–5 (0.1–0.01). Marked reductions in ARR in the switch group from Year 2–3 (0.1–0.053) were sustained through Years 3–5 (0.053–0.037). T2 lesion activity was suppressed in the continuous group up to Year 5, and from Year 3–5 (annualized number of new/enlarging T2 lesions: 1.29–0.043) in the switch group. In the continuous group, the odds of achieving no evidence of disease activity (NEDA-3) increased from 89% at Year 2 to 96% at Year 5, and in the switch group from 36% to 58% at Year 2–3, reaching 90% at Year 5. Six-year results will be presented at congress.

Conclusions:

Ofatumumab demonstrates sustained long-term efficacy in people with RDTN RMS, supporting its use early in the disease course.