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Antibody Shown to Reduce Disability in Multiple Sclerosis

Nerve cells in brain illustration


28 September 2015. A late-stage clinical trial shows an engineered antibody can reduce the extent of disability in people with primary progressive multiple sclerosis. The experimental drug, ocrelizumab, is made by Genentech, a biotechnology subsidiary of the pharmaceutical company Roche, in South San Francisco, California.

Multiple sclerosis is an autoimmune condition where the immune system attacks the central nervous system and damages myelin, the fatty, protective substance around nerve fibers, as well as nerve cells themselves. Scar tissue from the damaged myelin, known as sclerosis, distorts the nerve signals sent to and from the brain and spinal cord, causing symptoms ranging from mild numbness to loss of vision or paralysis. Primary progressive multiple sclerosis is a form of the disorder marked by steady deterioration in neurological functioning, without periods of remission or relapse.

Ocrelizumab is a synthetic antibody designed specifically to address a type of immune system cell known as CD20-positive B cells. B cells are white blood cells produced in the bone marrow that produce antibodies. CD20-positive B cells are considered contributors to damage in myelin and nerve cells associated with multiple sclerosis. Ocrelizumab binds to proteins emitted on the surface of CD20-positive B cells, but not on other immune system cells, and thus can avoid damaging other immune system functions.

The clinical trial recruited 732 individuals with primary-progressive multiple sclerosis at 217 locations worldwide. Participants in the trial, adults with mild to moderate disability — needing a cane or crutches to walk 20 meters without resting — were randomly assigned to receive intravenous infusions of ocrelizumab or a placebo, following pretreatment with methylprednisolone, a corticosteroid medication to treat inflammation.

The study’s main measure of efficacy was improvement on a standard scale of disability designed to track impairment caused by multiple sclerosis, sustained for at least 12 weeks. The trial also tracked reports of adverse effects from the treatments, volume of brain lesions from MRI scans, and related indicators of disability. Trial participants were monitored for 5.5 years following their treatments.

Genentech reports individuals receiving treatments with ocrelizumab show reliably less worsening of clinical disability, which they sustain for at least 12 weeks, compared to participants receiving the placebo. In addition, rates of adverse events including serious infections are similar for ocrelizumab and placebo recipients, mainly reactions at the infusion sites.

The company says the trial’s findings will be reported on 10 October at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona. Genentech is also carrying out late-stage trials of ocrelizumab with individuals having relapsing forms of multiple sclerosis, and results of those trials will be presented at the same meeting. The company plans to submit these findings to the U.S. Food and Drug Administration to support ocrelizumab’s application for approval early next year.

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