You are here:

Ofatumumab (Arzerra)

Other names: GSK 1841157

Ofatumumab is an experimental drug treatment for relapsing remitting MS. In clinical trials it has been taken as an intravenous infusion or as an injection under the skin (subcutaneous).

Summary

Ofatumumab for relapsing remitting MS: Phase II

Ofatumumab is an experimental drug treatment for relapsing remitting MS. In clinical trials it has been taken as an intravenous infusion or 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.

Ofatumumab research

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.

Intravenous infusion

  • 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.

Subcutaneous injection

  • In a phase II study (reported at American Academy of Neurology Annual Meeting 2014), 232 participants received different doses of ofatumumab (3 mg, 30 mg, or 60 mg given every 12 weeks; 60 mg every 4 weeks, or placebo followed by 3mg at week 12).

    Based on data collected for the first 12 weeks, 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 30 mg showed more than 90% reduction in new active MRI lesions.

What further research is planned?

No further studies are planned at present.

Side effects

In these early phase II studies, the most frequent side effects have been injection related reactions.

More references

  • Sorensen PS, et al. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: A phase 2 study. Neurology 2014;82:573-581. Summary
  • Bar-Or A, et al. The MIRROR study: a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the safety and MRI efficacy of subcutaneous ofatumumab in subjects with relapsing-remitting multiple sclerosis (RRMS) (I7-1.007) Neurology 2014:82(Suppl);Abstract I7-1.007 Summary

Last reviewed: April 2015
This page will be reviewed within three years