The following article is part of conference coverage from the 2022 American Academy of Neurology (AAN) Annual Meeting. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from the 2022 AAN Annual Meeting.

 

Most stable patients with multiple sclerosis (MS) who are on the approved 4-week (Q4W) dosing of natalizumab can switch to a 6-week (Q6W) dosing schedule without experiencing a clinically meaningful loss in treatment efficacy, according to study findings presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, held from April 2 to April 7 in Seattle, Washington, and virtually from April 24-26, 2022.


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Currently, natalizumab Q4W with 300 mg is approved as a relapsing-remitting MS treatment. Prior retrospective analyses have shown that a Q6W dosing frequency of natalizumab is associated with a lower risk of progressive multifocal leukoencephalopathy in patients with MS, the researchers explained. The objective of the current study was to evaluate the efficacy of the QW6 dosing frequency in patients with MS who had been treated with natalizumab Q4W without relapse for 12 or more months.

In their study, termed NOVA, none of the patients had any enhancing lesions at screening. The researchers randomly assigned patients to either Q6W or Q4W. A total of 195 patients in the Q4W group and 207 patients in the Q6W group completed NOVA. The study’s primary endpoint was new or newly enlarging T2 (N/NET2) lesions. Additionally, secondary endpoints of the study were relapses and 24-week confirmed disability worsening (CDW).

The proportions of patients who had N/NET2 lesions were comparatively low between the Q4W and Q6W dosing groups (4.1% vs 4.3%, respectively). The mean N/NET2 lesions with the primary estimand were 0.05 in the Q4W group and 0.20 in the Q6W group (P =.0755). With the secondary estimand, the mean N/NET2 lesions were 0.06 with Q4W and 0.31 with Q6W (P =.0437).

Differences in mean N/NET2 lesions were primarily due to 2 patients in the Q6W group with high values (25 or more lesions); however, the researchers noted that the distributions of N/NET2 lesions were otherwise comparable, and no other patient had more than 2.

Approximately 2.1% and 2.8% in the Q4W and Q6W groups, respectively, experienced relapse (P =.64). Rates of CDW were 8% with Q4W and 10% with Q6W (P =.40). The researchers reported that safety was similar between the groups.

“Despite a small difference in efficacy between arms, NOVA data suggest the vast majority of patients stable on Q4W dosing can switch to Q6W dosing with no clinically meaningful loss of efficacy,” the researchers concluded.

Reference

Foley J, Defer G, Ryerson LZ, et al. Primary results of NOVA: A randomized controlled study of the efficacy of 6‐week dosing of natalizumab versus continued 4-week treatment for multiple sclerosis. Presented at: the 2022 AAN Annual Meeting; April 2-7, 2022; Seattle, Washington; April 24-26, 2022; Virtual Meeting. Abstract S14.005.