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ABN Abstracts 2022
Poster presentations
145 Long-term safety of ofatumumab in patients with relapsing multiple sclerosis
  1. Stephen Hauser1,
  2. Anne Cross2,
  3. Kevin Winthrop3,
  4. Heniz Wiendl4,
  5. Jacqueline Nicholas5,
  6. Sven Meuth6,
  7. Paul Giacomini7,
  8. Francesco Saccà8,
  9. Wendy Su9,
  10. Ludwig Kappos10
  1. 1University of California, San Francisco
  2. 2Washington University School of Medicine, Missouri
  3. 3Public Health and Preventive Medicine, Oregon Health and Sciences
  4. 4University of Muenster, Germany
  5. 5OhioHealth Multiple Sclerosis Center
  6. 6Heinrich-Heine-University, Düsseldorf, Germany
  7. 7Montreal Neurological Institute, McGill University
  8. 8University Federico II of Naples, Italy
  9. 9Novartis Pharmaceuticals, USA
  10. 10Research Center for Clinical Neuroimmunology and Neuroscience Basel and MS Center

Abstract

Objective To assess the long term safety and tolerability of ofatumumab treatment in patients with relapsing multiple sclerosis (RMS)

Methods Patients completing the core ASCLEPIOS I/II, APOLITOS and APLIOS trials could enter ALITHIOS, an ongoing, open-label, extension trial. Here, we analyze the cumulative data for up to 4 years of ofa- tumumab treatment (data cutoff: 25-Sep-2021) in the overall (N=1969), continuous (ofatumumab in core+extension; N=1292) and newly-switched (teriflunomide core and ofatumumab extension; N=677) groups. Laboratory parameters including neutrophils, lymphocytes, and serum immunoglobulin (Ig) G and IgM levels will be analyzed.

Results In data reported from ALITHIOS (cut-off of 29-Jan-2021), representing ofatumumab treatment for up to ~3.5 years, 83.8% of patients had ≥1 AEs (exposure-adjusted incidence rate [EAIR], 148.7) and 9.7% had ≥1 serious AEs (EAIR, 4.8) with a low incidence of serious infections (2.9%; EAIR, 1.4) and malignancies (0.3%; EAIR, 0.3). Updated safety data representing continuous ofatumumab treatment for up to 4 years will be presented at the congress.

Conclusion Safety findings for up to 3.5 years show ofatumumab treatment to be generally well-tol- erated with no new safety risks identified. This additional safety data will help confirm ofatumumab’s longer-term safety profile. Funding: Novartis Pharma AG, Basel, Switzerland.

https://doi.org/10.1136/jnnp-2022-abn2.189

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