Phase 3 Trial Data on Satralizumab Monotherapy in Neuromyelitis Optica Spectrum Disorder Published
Satralizumab as a monotherapy for the treatment of neuromyelitis optica spectrum disorder (NMOSD) reduced the rate of relapse compared with placebo, according to the results of a phase 3 trial. Full data from the trial were published in Lancet Neurology.
NMOSD is a rare disease characterized by optic neuritis or myelitis.
In this phase 3, double-blind, placebo-controlled, parallel-group trial, adult patients with aquaporin-4 antibody seropositive or seronegative NMOSD who had experienced ≥ 1 documented NMOSD attack or relapse in the previous 12 months and had a score of ≤ 6·5 on the Expanded Disability Status Scale, were included.
Of the 168 participants screened, 95 were randomly assigned to receive treatment with satralizumab (n = 63) or placebo (n = 32)
During the study period, 19 patients receiving satralizumab relapsed compared to 16 receiving placebo (hazard ratio 0·45, 95% CI 0·23–0·89; P = 0,018)
Serious adverse events and adverse events leading to withdrawal was similar between groups.
The full manuscript can be found here.
Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurology. 2020;19(5):402-412.