Ofatumumab Treatment Up to Eight Years Shows a Favorable and Consistent Safety Profile in People Living With Relapsing Multiple Sclerosis
Gabriel Pardo1, Xavier Montalban2, Jeffrey Cohen3, Sarah Morrow4, Jun Li5, David Carr6, Gregory Pearce5, Maria Solonets5, Anil Abeyewickreme7, Jérôme de Seze8, Jin Nakahara9, Heinz Wiendl10, Stephen Hauser11
1Oklahoma Medical Research Foundation, Oklahoma City, OK, USA, 2Department of Neurology/Neuroimmunology, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d’Hebron, Barcelona, Spain, 3Department of Neurology, Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA, 4Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada, 5Novartis Pharma AG, Basel, Switzerland, 6IQVIA RDS GmbH, Frankfurt, Germany, 7Novartis Pharmaceuticals UK Ltd, London, United Kingdom, 8University Hospital of Strasbourg, Strasbourg, France, 9Department of Neurology, Keio University School of Medicine, Tokyo, Japan, 10Klinik für Neurologie und Neurophysiologie, Universitätsklinikum Freiburg, Freiburg, Germany, 11UCSF Weill Institute for Neurosciences, University of California, San Francisco, CA, USA
Objective:
To analyze the long-term safety profile of ofatumumab for up to 8 years (data cutoff: 25 September 2025) in people living with relapsing multiple sclerosis (plwRMS), including those recently diagnosed (≤3 years) and treatment-naive (RDTN).
Background:
Ofatumumab, a fully human anti-CD20 monoclonal antibody, demonstrated superior efficacy versus teriflunomide in the phase 3 ASCLEPIOS I/II trials in plwRMS. Previously reported data up to 7 years demonstrated a consistent safety profile and sustained efficacy in the overall population and RDTN participants.
Design/Methods:
Safety analyses will include participants receiving one or more ofatumumab doses in ASCLEPIOS I/II, APOLITOS, APLIOS, ARTIOS, or the umbrella extension study ALITHIOS. The analysis will be conducted in the overall population and the RDTN subgroup. Safety outcomes will include adverse events (AEs), serious AEs (SAEs), serious infections, injection-related reactions (IRRs), malignancies, and laboratory parameters (immunoglobulin [Ig] G, IgM, neutrophils, and lymphocytes).
Results:
Previously reported 7-year safety data showed an exposure-adjusted incidence rate (EAIR per 100 patient-years) of 112.95 and 124.96 for ≥1 AEs in the overall and RDTN populations, respectively, and low EAIRs for ≥1 SAEs (overall: 4.06; RDTN: 3.70); serious infections (overall: 1.37; RDTN: 1.24); IRRs (overall: 7.38; RDTN: 7.16); and malignancies (overall: 0.31; RDTN: 0.38). No increased risk in these outcomes was observed over time. Mean IgG levels remained stable up to 7 years of treatment; mean IgM levels initially decreased but then stabilized and remained above the lower limit of normal. Mean lymphocyte and neutrophil levels remained stable and similar to baseline levels with up to 7 years of ofatumumab treatment, in line with previous results. Updated 8‑year safety data will be presented at the congress.
Conclusions:
The 8-year results will provide further insights into the long-term safety of ofatumumab in plwRMS including RDTN plwRMS, supporting informed clinical decision-making.
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