Alternative Natalizumab Dosing Regimen Safe, Effective for Relapsing-Remitting Multiple Sclerosis
Researchers have found an alternative natalizumab administration route for patients with relapsing-remitting multiple sclerosis (RRMS), according to a study published in Multiple Sclerosis Journal.
The currently approved natalizumab regimen of 300 mg administered intravenously every 4 weeks has been shown to reduce confirmed disability worsening, disease activity on magnetic resonance imaging scans, and clinical relapse rate in addition to having a demonstrated effectiveness and long-term safety profile.
However, “An alternative administration route may… benefit patients on natalizumab,” wrote Professor Maria Trojano, University of Bari, Bari, Italy, and co-investigators. “IV infusion requires visits to an infusion center, which may not be readily accessible to all patients with multiple sclerosis (MS).”
A total of 290 clinically stable patients with RRMS were enrolled in this phase 2 exploratory trial throughout Belgium, Germany, Spain, France, and Italy from December 2010 to October 2014. Patients previously treated with 300 mg of natalizumab intravenously for greater than 12 months were randomized into 6 groups with varying natalizumab regimens over 60 weeks to examine efficacy and safety of various administration methods of natalizumab.
Participants received either 300 mg intravenously or subcutaneously every 4 weeks, 300 mg intravenously or subcutaneously every 12 weeks, 150 mg intravenously or subcutaneously every 12 weeks.
The primary endpoint was the mean cumulative number of combined unique active lesions on magnetic resonance imaging scans at week 60. Scans were completed and data on pharmacokinetics, pharmacodynamics, clinical outcomes, and safety were collected at baseline and at weeks 12, 24, 36, 48, and 60.
All patients in 12-week dosing arms were associated with increased clinical relapses and MRI disease activity and closed early.
Patients that received 300 mg subcutaneously every 4 weeks saw similar results with efficacy, safety, pharmacokinetics, and pharmacodynamics to the current standard natalizumab administration route of 300 mg intravenously every 4 weeks.
Natalizumab 300 mg subcutaneously Q4W was comparable to standard 300 mg intravenously Q4W with respect to clinical and MRI efficacy, pharmacokinetics and pharmacodynamics, and safety. Trojano et al concluded, “These results suggest that SC administration of 300 mg natalizumab Q4W could be an alternative option for patients with RRMS.”
Source: Trojano M, Ramió-Torrentà L, Grimaldi LM, et al. A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis [published online ahead of print, 2021 Apr 6]. Mult Scler. 2021;13524585211003020. doi:10.1177/13524585211003020