Most patients with relapsing-remitting multiple sclerosis (RRMS) who are stable on natalizumab (Tysabri, Biogen) administered once every 4 weeks (Q4W) may be able to safely switch to a once every 6 weeks (Q6W) dosing interval with no clinically meaningful loss of efficacy, new research shows.
The hope is that Q6W dosing may lower the risk of progressive multifocal leukoencephalopathy (PML), although the NOVA trial was not powered to assess differences in risk of PML, investigators led by John Foley, MD, Rocky Mountain MS Clinic, Salt Lake City, Utah, note.
The study was published online April 25 in Lancet Neurology.
Comparable Disease Control
Natalizumab is approved for Q4W dosing as a 300-mg intravenous infusion.
The open-label, phase 3b NOVA study tested the safety and efficacy of natalizumab Q6W and Q4W dosing in 499 patients with RRMS at 89 MS centers across 11 countries.
All patients had been treated with the approved Q4W dosing regimen of natalizumab with no relapses for at least 12 months; 251 switched to Q6W dosing and 248 remained on Q4W dosing.
The primary endpoint was the number of new or newly enlarging T2 hyperintense lesions at week 72, assessed in all participants who received at least one dose of assigned treatment and had at least one MRI, relapse, or neurological examination or efficacy assessment after baseline.
