1. (DMT20) Longer-Term (Up to 6 Years) Efficacy of Ofatumumab in People With Recently Diagnosed and Treatment-Naive Relapsing Multiple Sclerosis.
- Author
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Pardo, Gabriel, Hauser, Stephen L., Bar-Or, Amit, Gold, Ralf, Montalban, Xavier, Cohen, Jeffrey A., Robertson, Derrick S., Hersh, Carrie M., Naismith, Robert T., Deiva, Kumaran, Bhatt, Alit, Haoyi Fu, Boer, Ibolya, Meuth, Sven G., Cross, Anne H., Gärtner, Jutta, and Kappos, Ludwig
- Subjects
MULTIPLE sclerosis ,CONFERENCES & conventions ,RANDOMIZED controlled trials ,MONOCLONAL antibodies ,DRUG efficacy ,DISEASE relapse ,EVALUATION - Abstract
BACKGROUND: Ofatumumab, a fully human anti-CD20 monoclonal antibody with a 20-mg subcutaneous monthly dosing regimen, demonstrated superior efficacy and similar safety vs teriflunomide in the phase 3 ASCLEPIOS I/II overall population and in a subgroup of participants with recently diagnosed treatmentnaive (RDTN; diagnosed ≤ 3 years) relapsing multiple sclerosis (RMS). Data from the ALITHIOS open-label extension study previously demonstrated sustained efficacy for up to 5 years in the overall population and up to 4 years in the RDTN groups. OBJECTIVES: To assess ofatumumab's longer-term efficacy for up to 6 years in people with RDTN RMS. METHODS: These analyses (data cutoff: September 25, 2022 [up to 5 years]/September 25, 2023 [up to 6 years]) include cumulative data from the RDTN subgroups randomly assigned to ofatumumab in the core (continuous group) and those originally randomly assigned to teriflunomide and switching to ofatumumab in ALITHIOS (switch group). RESULTS: The RDTN subgroup comprised 314 and 301 people in the continuous and switch groups, respectively (mean age at baseline, 36.8/35.7 years; 69.1%/65.8% female; mean Expanded Disability Status Scale score, 2.30/2.28). In the 5-year analyses, the RDTN continuous group sustained a low annualized relapse rate (ARR) over years 1 to 5 (0.1-0.01). Marked reductions in ARR in the switch group from years 2 to 3 (0.1-0.053) were sustained through years 3 to 5 (0.053-0.037). T2 lesion activity was suppressed in the continuous group up to year 5 and from years 3 to 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 increased from 89% at year 2 to 96% at year 5 and in the switch group from 36% to 58% at years 2 to 3, reaching 90% at year 5. Six-year results will be presented at the annual meeting. CONCLUSIONS: Ofatumumab demonstrates sustained long-term efficacy in people with RDTN RMS, supporting its use early in the disease course. [ABSTRACT FROM AUTHOR]
- Published
- 2024