Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): A double-blind, randomised placebo-controlled phase 2/3 trial
The Lancet Sep 13, 2019
Cree BAC, Bennett JL, Kim HJ, et al. – Researchers determined inebilizumab is an effective and safe treatment option for attenuating the risk of attacks and disability in neuromyelitis optica spectrum disorder (NMOSD) in this multicenter, double-blind, randomized, placebo-controlled, phase 2/3 study conducted in 25 countries. This study included 230 participants who were randomized (3:1) to 300-mg intravenous inebilizumab (n = 174) or placebo (n = 56). Time to onset of an NMOSD attack, as determined by the adjudication committee, was considered as the primary endpoint. Findings revealed a lowered risk of an NMOSD attack in correlation with treatment with inebilizumab vs placebo. In the inebilizumab group and in the placebo group, 125 of 174 participants and 41 of 56 experienced adverse events, respectively. Overall, the potential of inebilizumab as an evidence-based treatment for use in patients with NMOSD was supported.
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