Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial
Journal: The Lancet Neurology; May 1, 2020
Author(s): Anthony Traboulsee, Benjamin M Greenberg, Jeffrey L Bennett, Lech Szczechowski, Edward Fox, Svitlana Shkrobot, Takashi Yamamura, Yusuke Terada, Yuichi Kawata, Padraig Wright, Athos Gianella-Borradori, Hideki Garren, Brian G Weinshenker
Safety and efficacy of satralizumab treatment alone in NMOSD
In an earlier clinical trial study (called the SAkuraSky study), satralizumab combined with immunosuppressants was found to be effective in reducing NMOSD relapses. In this clinical trial study (called the SAkuraStar study), the efficacy and safety of satralizumab alone was assessed in NMOSD patients. This study was conducted on adult NMOSD patients (seropositive or seronegative) at 44 centers in 13 countries. 95 NMOSD patients were randomly assigned to receive satralizumab (without any other immunosuppressants) or placebo. The outcomes assessed were (a) the time to a relapse occurring after treatment, and (b) the occurrence of adverse events. The results showed that satralizumab monotherapy reduced the rate of NMOSD relapse compared with placebo; the incidence of serious adverse events and adverse events leading to treatment withdrawal was similar between patients who received satralizumab and placebo.
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