Biogen released results from its phase 3b NOVA study, with findings demonstrating the efficacy of an every-6-week dosing regimen of natalizumab (Tysabri®) in patients being treated for relapsing-remitting multiple sclerosis (RRMS).
“The NOVA study provides the first prospective, randomized efficacy data of every six-week dosing with natalizumab, building on its well-established clinical profile and the real-world findings,” according to Maha Radhakrishnan, MD, chief medical officer at Biogen.
The NOVA study (NCT03689972) aimed to evaluate the efficacy of an every-6-week intravenous administration of 300 mg of natalizumab in RRMS patients who switched from the currently approved dose (300 mg every 4 weeks).
The study authors found no statistically significant differences in primary outcome measures between the standard regimen group (Q4W) and the 6-week regimen group (Q6W). The mean number of new or newly enlarging T2 hyperintense lesions, analyzed by magnetic resonance imaging (MRI) scans of the brain at week 72, were 0.05 for Q4W and 0.20 for Q6W (P =.0755). Moreover, the percentage of patients with new or newly enlarging T2 lesions was 4.1% and 4.3% in Q4W and Q6W, respectively.
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In addition, the study team did not find any statistically significant difference between the arms in secondary outcome measures. Annualized relapse rates remained low in the Q6W arm (0.00013 vs 0.00010), with 97.2% of the patients remaining relapse-free (vs 97.9% in the Q4W arm). Also, the number of new gadolinium-enhancing and new T1 hypointense lesions were equivalent between the arms.
Both safety findings and serious adverse events were consistent with previous findings and similar between the two treatment arms.
These results add value to the most recent data from the Tysabri Outreach: Unified Commitment to Health (TOUCH) Prescribing Program, which reported an 88% lower probability (hazard ratio, 0.118, P <.0001) of progressive multifocal leukoencephalopathy in patients treated with a 6-week natalizumab dosing schedule when compared to patients receiving the approved dose.
Natalizumab is a disease-modifying treatment used in patients with relapsing forms of MS. Its use has been associated with progressive multifocal leukoencephalopathy, a rare opportunistic viral infection of the brain.
Biogen announces results from phase 3b NOVA study evaluating every six-week dosing with natalizumab in relapsing-remitting multiple sclerosis. News release. Biogen; August 2, 2021.
A study to evaluate efficacy, safety, and tolerability of EID of natalizumab (BG00002) in participants with RRMS switching from treatment with natalizumab SID in relation to continued SID treatment- followed by extension study comprising SC and IV natalizumab administration. ClinicalTrials.gov. October 1, 2018. Updated September 18, 2020. Accessed August 4, 2021.
Ryerson LZ, Foley J, Kister I, et al. Natalizumab extended interval dosing (EID) is associated with a reduced risk of progressive multifocal leukoencephalopathy (PML) compared with every-4-week (Q4W) dosing: updated analysis of the TOUCH® prescribing program database (4419). Neurology. 2021;96(15 Supplement):4419. Published online April 13, 2021.