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Results Published from Phase 3 Clinical Trials of Ofatumumab in Relapsing MS

August 5, 2020

In two Phase 3 trials that included 1,882 people with relapsing MS, ofatumumab (Novartis) injected under the skin monthly reduced relapses significantly more than daily oral Aubagio® (teriflunomide, Sanofi Genzyme). Top-line results were announced in August 2019, and details have now been published in the peer-reviewed New England Journal of Medicine. Novartis has applied for approval from the U.S. Food and Drug Administration.
  • Ofatumumab is a monoclonal antibody that binds to a docking site (CD20) on some immune B cells and depletes them. B cells are among immune cells that have been implicated in causing nervous system damage in MS. One B-cell therapy currently approved to treat MS is Ocrevus® (Genentech).
  • Two identical phase 3 studies (ACLEPIOS I and II) were conducted for up to 30 months. Participants were randomly assigned to receive ofatumumab, self-injected once a month, or daily oral teriflunomide for up to 30 months. As a control, the groups also received placebo versions of ofatumumab or teriflunomide. The primary outcome measured was the annual rate of relapses. Secondary endpoints included time to progression of disability, rate of brain volume loss and other measures.
  • The studies achieved the primary outcome, meaning that ofatumumab reduced annual relapses significantly more than teriflunomide. Disability worsening at three and six months, and disease activity on MRI scans, were also reduced significantly more in the groups receiving ofatumumab. Brain tissue loss was not reduced significantly more in the ofatumumab group.
  • Adverse events that occurred in at least 10% of participants in groups taking ofatumumab included injection-related reactions, headache, upper respiratory tract infection, and urinary tract infection. Appendicitis occurred in 8 people in ofatumumab groups and 2 in the teriflunomide groups; this had not occurred in previous studies.
  • Novartis has applied to the FDA for approval of ofatumumab to treat MS, and a decision is expected in September 2020.
  • Read more about treatment options for MS.
“Ofatumumab versus Teriflunomide in Multiple Sclerosis” is published by Stephen L. Hauser, MD (University of California, San Francisco), Ludwig Kappos, MD (University Hospital Basel) and colleagues in The New England Journal of Medicine (2020;383:546-57). 
Aubagio is a registered trademark of Sanofi Genzyme
Ocrevus is a registered trademark of Genentech, a member of the Roche Group


About Multiple Sclerosis

Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.

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