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ABN Abstracts 2022
Poster presentations
144 Long-term efficacy of ofatumumab in patients with relapsing multiple sclerosis
  1. Stephen Hauser1,
  2. Edward Fox2,
  3. Angela Aungst3,
  4. Wendy Su4,
  5. Ronald Zielman5,
  6. Ayan Das Gupta6,
  7. Dee Stoneman7,
  8. Derrick Robertson3,
  9. Jeffrey Cohen8,
  10. Ludwig Kappos9
  1. 1University of California, San Francisco
  2. 2University of Texas Dell Medical School/Round Rock, Texas, USA
  3. 3Department of Neurology, University of South Florida
  4. 4Novartis, USA
  5. 5Novartis, Netherlands
  6. 6Novartis Healthcare Pvt. Ltd, India
  7. 7Novartis Pharma, Switzerland
  8. 8Mellen MS Center, Neurological Institute, Cleveland Clinic, Cleveland, OH
  9. 9Research Center for Clinical Neuroimmunology and Neuroscience Basel and MS Center

Abstract

Objective To assess the long-term efficacy of ofatumumab treatment for up to ~4 years in patients with relapsing multiple sclerosis (RMS).

Methods This analysis (data cut-off: 25-Sep-2021) will include cumulative data from patients randomised to ofatumumab/teriflunomide in the ASCLEPIOS I/II trials (core study) and the ongoing, open-label, ALITHIOS extension study. Patients will be analyzed in two groups: those randomised to ofatumumab in the core (continuous group) and those randomised to teriflunomide in the core with potential switch to ofatumumab in the extension (switch group). Annualised relapse rate (ARR), disability worsening (time- to-3-month/6-month confirmed disability worsening), disability improvement (time-to-6-month confirmed disability improvement), and brain MRI outcomes (number of Gd+T1 lesions and annualised T2 lesion rate) will be assessed.

Results Overall, 1882 patients who were randomised in the ASCLEPIOS I/II trials (ofatumumab/terifluno- mide: 946/936) will be included in the analysis. In total, 690/946 patients treated with ofatumumab and 677/936 patients treated with teriflunomide entered ALITHIOS. Updated efficacy results for up to ~4 years will be presented at the congress.

Conclusions These analyses will provide insights on the sustained efficacy of continuous ofatumumab treatment for up to 4 years in patients with RMS, and on ofatumumab efficacy in patients newly switched from teriflunomide. Funding: Novartis Pharma AG, Basel, Switzerland.

https://doi.org/10.1136/jnnp-2022-abn2.188

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