Ofatumumab (also known as Arzerra®)

Experimental Medications: Monoclonal Antibodies

Company: Novartis

  • Given via IV infusion and also studied via subcutaneous injection
  • Being studied in RMS

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Like Rituxan and Ocrevus, ofatumumab is an anti-CD20 monoclonal antibody. It has the potential advantage of being a human monoclonal antibody (versus antibodies from non-human species that have been modified). Ofatumumab has a unique target on the CD20 molecule and is approved for certain forms of leukemia.

Two simultaneous Phase III clinical trials – ASCLEPIOS I and ASCLEPIOS II – are comparing ofatumumab to teriflunomide in patients with RMS. Investigators in both trials are following patients aged 18 to 55 years with a baseline Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at screening. An EDSS score of less than 4.0 represents moderate disability, while a score between 4 and 5.5 indicates more severe MS-related disability that could interfere with daily activities.

Participants in both trials will receive either subcutaneous ofatumumab at three weekly 20-mg doses for two weeks followed by one 20-mg injection every four weeks, or oral teriflunomide 14 mg daily. The primary endpoint for both trials is the annual rate relapse. Secondary endpoints include MRIrelated outcomes and confirmed disability worsening at three and six months. The 1,884 people enrolled in the two studies represent a typical RMS population (more than 65 percent female and 90 percent Caucasian). Sixty percent of the participants had received another disease-modifying therapy prior to entering the studies, and 40 percent showed enhancing lesions on MRI at screening. The trials are scheduled for completion around May 2019.52,54

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