Other names: GSK 1841157, Arzerra
Ofatumumab for relapsing remitting MS: Phase III
Ofatumumab is an experimental drug treatment for relapsing remitting MS. In clinical trials it has been taken as an injection under the skin (subcutaneous).
- Ofatumumab reduces the number of B cell lymphocytes, a type of white blood cell which is thought to influence the abnormal immune response that causes the attack on the myelin coating of nerves.
- Preliminary results indicate that for relapsing remitting MS ofatumumab significantly reduced the number of new active lesions seen on MRI.
How does ofatumumab work?
Ofatumumab is a monoclonal antibody, a type of drug developed to attack specific targets in the immune system. Ofatumumab has been designed to bind to a marker (CD20) on the surface of B cell lymphocytes, a type of white blood cell which is thought to influence the abnormal immune response that causes the attack on the myelin coating of nerves. Targeted B cells are destroyed.
Ofatumumab is currently used as a treatment for chronic lymphocytic leukaemia.
How is ofatumumab taken?
Ofatumumab is taken as an injection under the skin.
What are the results so far?
An initial phase II trial evaluated ofatumumab given as an intravenous infusion; the drug is now being developed as a subcutaneous injection.
In a phase II clinical trial, 38 participants received 2 ofatumumab infusions (100 mg, 300 mg, or 700 mg) or placebo 2 weeks apart. After 24 weeks, the participants first treated with placebo were treated with ofatumumab and patients who were initially treated with ofatumumab received placebo. All patients were then followed for an additional 24 weeks.
Ofatumumab treatment produced a major reduction in B cell numbers. For all doses of ofatumumab, there was almost complete suppression of new active lesions seen on MRI.
- MIRROR - ofatumumab compared to placebo
232 participants took different doses of ofatumumab (3 mg, 30 mg, or 60 mg given every 12 weeks; 60 mg every 4 weeks, or placebo) for a 24-week treatment period. The main measure of the study was the number of new active MRI lesions at week 12. All doses resulted in 65% reduction in new active MRI lesions. Based on data collected from weeks 4 to 12, those taking cumulative doses of at least 30mg showed more than 90% reduction in new active MRI lesions.
What further research is planned?
- ASCLEPIOS I - ofatumumab compared to Aubagio (teriflunomide)
- ASCLEPIOS II - ofatumumab compared to Aubagio (teriflunomide)
These phase III studies are recruiting a total of 1830 participants with relapsing remitting MS. Participants will take either ofatumumab by subcutaneous injections every four weeks or Aubagio (teriflunomide) once daily for up to 2.5 years. The main measure of the study is the average number of relapses in a year. Disability improvement or worsening, number of active and total lesions, and brain volume will also be measured.
Estimated completion date May 2019.
Further details of ASCLEPIOS I
Further details of ASCLEPIOS II
In phase II studies, the most frequent side effects have been injection related reactions. Most of these were of mild to moderate severity, resolved the same of following day and were associated with the first ofatumumab dose; they were less frequent with subsequent ofatumumab dosing.
Last reviewed: October 2018
Last updated: October 2018
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