August 3, 2021 – Abby Reinhard
Efficacy data from a trial examining extended dosing adds to real-world data that demonstrates a significant reduction in the probability of progressive multifocal leukoencephalopathy infection.
Maha Radhakrishnan, MD
Results from the phase 3b NOVA study (NCT03689972) showed no statistically significant differences in efficacy when extending the approved 4-week (QW4), 300-mg natalizumab (Tysabri, Biogen) intravenous (IV) dosing schedule to a 6-week (QW6) schedule in patients with relapsing-remitting multiple sclerosis (MS). The study findings complement real-world data that suggest a QW6 dosing schedule may significantly reduce the risk of developing progressive multifocal leukoencephalopathy (PML).
The randomized, controlled, open-label, rater-blinded study enrolled 500 participants, all of whom had at least 1 year of disease stability on the QW4 IV dosing schedule. In studying each treatment arm, investigators saw a mean number of new or newly enlarging T2 hyperintense lesions at week 72 of 0.20 in the Q6W group compared with 0.05 in the Q4W group (P = .0755), showing no clinical significance. The higher lesion count in the Q6W group was largely attributed to a patient who developed lesions 3 months after discontinuing treatment and another who developed asymptomatic PML. The efficacy data coincide with an updated safety analyses of the Tysabri Outreach: Unified Commitment to Health (TOUCH) Prescribing Program which showed an 88% reduction in the probability of developing PML infection in the Q6W dosing group (hazard ratio [HR] 0.118; P <.0001) when compared with the Q4W dosing regimen.1
“The NOVA study provides the first prospective, randomized efficacy data of every 6-week dosing with natalizumab, building on its well-established clinical profile and the real-world findings,” Maha Radhakrishnan, MD, chief medical officer, Biogen, said in a statement.1 “In addition to the safety analyses from the TOUCH Prescribing Program, which showed significant reduction in the probability of PML, the results from NOVA deliver a more comprehensive understanding of the 6-week dosing regimen of natalizumab.”
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