Treatment with ofatumumab (Novartis) was associated with a greater proportion of patients with relapsing forms of multiple sclerosis (RMS) achieving no evidence of disease activity (NEDA-3), compared with those who received teriflunomide, according to post hoc analysis of the phase 3 ASCLEPIOS trials. The new data were presented virtually at the 6th Congress of the European Academy of Neurology (EAN).
The phase 3 ASCLEPIOS I and II trials compared the efficacy and safety of ofatumumab, a CD20-directed cytolytic monoclonal antibody, to teriflunomide, a pyrimidine synthesis inhibitor, in 1882 adults with RMS. The post hoc analysis assessed both treatment arms for achieving no evidence of disease activity (NEDA-3) within the first (month 0-12) and second year (month 12-24), defined as an absence of relapses, disease progression, and gadolinium enhancing (Gd+) T1 lesions. Results demonstrated that a greater proportion of patients treated with ofatumumab achieved NEDA-3 vs teriflunomide in year 1 (47.0% vs 24.5%; P <.001) and in year 2 (87.8% vs 48.2%; P <.001).
Additionally, analysis from the APLIOS trial in 284 adults with RMS showed that treatment with ofatumumab led to rapid and sustained depletion of both CD20+ B- and T-cells, including memory B-cells and naïve B-cells along with a subset of T-cells that are known to exhibit an activated phenotype. Ofatumumab did not affect CD3+ T-cells.
“Achieving no evidence of disease activity is widely recognized as an important treatment goal for multiple sclerosis therapies,” said Professor Ludwig Kappos, University Hospital Basel. “These data suggest that halting new disease activity is possible by targeted B-cell therapy in RMS.”
In February 2020, the Food and Drug Administration (FDA) accepted for Priority Review the supplemental Biologics License Application (sBLA) for ofatumumab for the treatment of RMS in adults. Regulatory action is expected in June 2020.
Ofatumumab is marketed under the brand name Arzerra and is currently approved for the treatment of chronic lymphocytic leukemia (CLL).
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