{
  "abstract": "Background/Objectives Previously reported data up to 6 years of ofatumumab treatment demonstrated a favourable safety profile and sustained efficacy. Here we describe long-term safety of ofatumumab and assess disability outcomes (up to 7 years) of early initiation of ofatumumab treatment versus delayed treatment (after switching from teriflunomide) in people with relapsing multiple sclerosis (pwRMS).Methods Safety analyses include participants who received ≥1 dose of ofatumumab in ASCLEPIOS I/II, APOLITOS, APLIOS, or ALITHIOS. Efficacy analyses evaluate cumulative data up to 7 years (cutoff: 25-Sep-2024) from pwRMS randomized to ofatumumab or teriflunomide in ASCLEPIOS I/II, regardless of whether they entered the ALITHIOS open-label extension phase. Event rates of 3/6-month (m) confirmed disability worsening (3/6mCDW), progression independent of relapse activity (3/6mPIRA; CDW events without prior confirmed relapses), and relapse-associated disability worsening (3/6mRAW; disability onset <90 days from relapse) will be assessed.Results Exposure-adjusted incidence rates of adverse events (AEs), serious AEs, serious infections, and malignancies remained low and consistent, with no increased risk over 6 years. Previously reported 6-year data (cutoff: 25-Sep-2023) showed Kaplan-Meier cumulative event rates were numerically lower in pwRMS receiving continuous ofatumumab in ASCLEPIOS I/II and ALITHIOS (OMB-OMB) versus delayed treatment (TER-OMB) for 6mCDW (21.1% vs 24.8%, p=0.063), 6mPIRA (15.5% vs 16.6%), and 6mRAW (5.2% vs 5.8%). Updated 7-year safety and efficacy data will be presented at the congress.Conclusion These analyses will further support long-term safety and efficacy data for ofatumumab in pwRMS, including RDTN pwRMS, informing clinical decision-making.",
  "authors": [
    {
      "affiliations": [
        "Oklahoma Medical Research Foundation, Oklahoma City, OK, USA"
      ],
      "name": "Gabriel Pardo"
    },
    {
      "affiliations": [
        "Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA"
      ],
      "name": "Amit Bar-Or"
    },
    {
      "affiliations": [
        "Centre d’Esclerosi Multiple de Catalunya (Cemcat), Hospital Universitario Vall d’Hebron, Barcelona, Spain"
      ],
      "name": "Xavier Montalban"
    },
    {
      "affiliations": [
        "Department of Neurology, Keio University School of Medicine, Tokyo, Japan"
      ],
      "name": "Jin Nakahara"
    },
    {
      "affiliations": [
        "Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada"
      ],
      "name": "Sarah A Morrow"
    },
    {
      "affiliations": [
        "Novartis Healthcare PtyLtd, Hydrabad, India"
      ],
      "name": "Alit Bhatt"
    },
    {
      "affiliations": [
        "Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"
      ],
      "name": "Min Wu"
    },
    {
      "affiliations": [
        "Novartis Pharma AG, Basel, Switzerland"
      ],
      "name": "Gregory L Pearce"
    },
    {
      "affiliations": [
        "Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA"
      ],
      "name": "Roseanne Sullivan"
    },
    {
      "affiliations": [
        "Novartis Pharmaceuticals UK Ltd, London, UK"
      ],
      "name": "Anil Abeyewickreme"
    },
    {
      "affiliations": [
        "University Hospital of Strasbourg, Strasbourg, France"
      ],
      "name": "Jerome de Seze"
    },
    {
      "affiliations": [
        "Klinik für Neurologie und Neurophysiologie, Universitätsklinikum Freiburg, Freiburg, Germany"
      ],
      "name": "Heinz Wiendl"
    },
    {
      "affiliations": [
        "Department of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, California, USA"
      ],
      "name": "Stephen L Hauser"
    },
    {
      "affiliations": [
        "Department of Neurology, Royal North Shore Hospital, Sydney, NSW, Australia",
        "University of Sydney, Sydney, NSW, Australia"
      ],
      "name": "John Parratt"
    }
  ],
  "title": "3549 Continuous ofatumumab treatment up to 7 years shows a consistent safety profile and delays disability progression in people with RMS",
  "uid": "4a1b8984-8f85-5b95-804a-5e2aeb8dc992"
}