Study Tests Extending Natalizumab Dosing Schedule in MS Patients
Extending the dose of Tysabri (natalizumab; Biogen) from 4 weeks up to 8 weeks was well tolerated and effective in patients with multiple sclerosis (MS), as observed in a trial conducted by researchers at the NYU Langone Multiple Sclerosis Comprehensive Care Center. The findings were presented at the American Academy of Neurology's 67th Annual Meeting in Washington, D.C.
The study, led by Lana Zhovtis-Ryerson, MD, investigated the safety and efficacy of an extended dose of natalizumab vs. standard dose. Researchers compared 1,078 patients taking standard 4-week dose to 866 patients taking an extended dose between 4 weeks, 3 days and 8 weeks, 5 days.
Results demonstrated that extending the dosing schedule between 5 and 8 weeks did not affect the drug's efficacy profile, with 65% of participants in each group not showing clinical MS activity, and comparable rates of new lesions reported on imaging. No cases of progressive multifocal leukoencephalopathy (PML) were reported in the extended dosing group, while two cases were reported in the standard dose group, which has not reached statistical significance.
Natalizumab is a monoclonal antibody used to prevent MS symptoms and flare-ups and slow worsening disability.
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