Results Announced from Phase 3 Studies of Ofatumumab in Relapsing MS
August 30, 2019
SUMMARY
- Top-line results were announced from two Phase 3 studies comparing ofatumumab (Novartis) to oral Aubagio® (teriflunomide, Sanofi Genzyme) in people with relapsing MS. Ofatumumab is self-administered as a monthly under-the-skin injection.
- According to a company press release, the studies met their primary and key secondary endpoints, significantly reducing the annual relapse rates compared to Aubagio.
- Details about side effects were not provided in the press release. Safety is said to be in line with those observed in a previous phase 2 study, which reported chiefly injection-site reactions as the most common adverse event.
- Further details will be presented at the 2019 Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in September. The company plans to apply to drug regulatory agencies by the end of this year.
DETAILS
Background: Multiple sclerosis involves an immune system attack on the brain and spinal cord. Ofatumumab is a monoclonal antibody that binds to a docking site (CD20) on immune B cells (lymphocytes) 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 by the FDA to treat MS is Ocrevus
® (Genentech). In an earlier phase II study in people with relapsing MS, ofatumumab significantly reduced disease activity seen on MRI scans --
Neurology May 15, 2018; 90 (20).
The Study: Two identical phase 3 studies (ACLEPIOS I and II) were conducted for up to 30 months and involved 1,882 people with relapsing MS. Participants were randomly assigned to receive under-the-skin injections of ofatumumab, self-administered once a month, or teriflunomide, 14 mg once daily, for up to 30 months. The primary outcome that was measured was the annual rate of relapses. Secondary endpoints included time to progression of disability, rate of brain volume loss and other measures.
Results: According to a company press release, the study met primary and key secondary endpoints, significantly reducing the annual relapse rate in adults with relapsing MS. It also met the secondary endpoint of delaying the time to disability progression. Details about side effects were not provided in the press release. Safety is said to be in line with that reported from a previous phase 2 study, which reported chiefly injection-site reactions as the most common adverse event.
Further details will be presented at the 2019 Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in September. The company plans to submit applications for approval from drug agencies such as the U.S. Food and Drug Administration in late 2019.
Aubagio is a registered trademark of Sanofi Genzyme
Ocrevus is a registered trademark of Genentech, a member of the Roche Group