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Extending Dosing Intervals Reduces Deadly Side Effect Risk from Popular Multiple Sclerosis Drug

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SAN DIEGO, Feb. 2, 2018 /PRNewswire-USNewswire/ — A commonly-prescribed multiple sclerosis (MS) infusion medication linked to a rare but serious side effect is safer to use when dosing intervals are extended, according to a new study led by MS specialists at NYU Langone Health.

Lead study author Dr. Lana Zhovtis Ryerson is an assistant professor of neurology at NYU School of Medicine and an attending neurologist at NYU Langone’s Multiple Sclerosis Comprehensive Care Center.

The new research showed that extending dosing of natalizumab from every 4 weeks to every 5 to 12 weeks significantly reduced the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection. The authors presented their findings February 2 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 in San Diego.

The findings could influence how neurologists prescribe the medication. “Neurologists have been looking for safer ways to administer natalizumab infusions to their patients, but there hasn’t been clear data on whether decreasing dosing frequency improves safety,” says first study author Lana Zhovtis Ryerson, MD, assistant professor of neurology at NYU School of Medicine and an attending neurologist at NYU Langone’s Multiple Sclerosis Comprehensive Care Center. “Our safety findings are clinically and statistically significant, and we believe that extending the dosing schedule of natalizumab is practice changing and may save lives.”

Natalizumab, a monoclonal antibody, is used to prevent MS relapses, improve quality of life, and slow worsening disability. The medication is indicated to be prescribed in 300-milligram infusion doses every 4 weeks.

Taking the medication longer than two years, however, may increase risk PML, which is caused by the John Cunningham virus (JCV). There have been 756 PML cases reported worldwide as of January 2018, with a global incidence rate of 4.19 per 1,000 PML cases in people treated with natalizumab. Patients who test JCV antibody-positive are typically either told to not to start natalizumab, or have had treatment stopped after two years, when risk was deemed to be too high.

The new study, however, reports safety data through up to 72 months, or 6 years, when the extended dosing regimens were applied, with risk reduction for PML as high as 94 percent.

How the Study Was Conducted

Researchers reviewed data on all patients who have been exposed

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