Efficacy of Satralizumab As Monotherapy in Pre-Specified Subgroups of Sakurastar, a Double-Blind Placebo-Controlled Phase 3 Clinical Study in Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

2020 ◽  
Vol 37 ◽  
pp. 101576
Author(s):  
Jeffrey L. Bennett ◽  
Benjamin Greenberg ◽  
Anthony Traboulsee ◽  
Lech Szczechowski ◽  
Edward Fox ◽  
...  
Keyword(s):  
Clinical Study ◽  
Neuromyelitis Optica ◽  
Spectrum Disorder ◽  
Neuromyelitis Optica Spectrum Disorder ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial

2020 ◽  
Vol 19 (5) ◽  
pp. 402-412 ◽  
Author(s):  
Anthony Traboulsee ◽  
Benjamin M Greenberg ◽  
Jeffrey L Bennett ◽  
Lech Szczechowski ◽  
Edward Fox ◽  
...  
Keyword(s):  
Neuromyelitis Optica ◽  
Spectrum Disorder ◽  
Neuromyelitis Optica Spectrum Disorder ◽  
Phase 3 ◽  
Double Blind ◽  
Safety And Efficacy

Satralizumab in the treatment of neuromyelitis optica spectrum disorder

2021 ◽  
Vol 11 (1) ◽  
pp. 49-59
Author(s):  
Ankelien Duchow ◽  
Judith Bellmann-Strobl
Keyword(s):  
Neuromyelitis Optica ◽  
Subcutaneous Administration ◽  
Spectrum Disorder ◽  
Phase Iii ◽  
Neuromyelitis Optica Spectrum Disorder ◽  
Double Blind ◽  
Good Tolerability ◽  
Positive Effects ◽  
Humanized Monoclonal Antibody ◽  
Phase Iii Trials

Neuromyelitis optica spectrum disorder (NMOSD) is a rare and debilitating autoimmune astrocytopathy with a predominantly relapsing disease course. Satralizumab, a humanized monoclonal antibody, was designed to treat NMOSD by targeting the IL-6 receptor. Satralizumab builds on positive experiences of off-label use tocilizumab in recent years. Before 2019, no medications were approved for the treatment of NMOSD. In 2020, satralizumab became the third compound to enter the US market, adding to the complement inhibitor eculizumab and the CD19 inhibitor inebilizumab. Here, we review the two randomized, double-blind, Phase III trials that investigated the subcutaneous administration of satralizumab as add-on treatment and monotherapy. Both studies revealed positive effects concerning the reduction of relapse risk for AQP4 seropositive NMOSD patients and generally good tolerability.

Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial

The Lancet ◽  
2019 ◽  
Vol 394 (10206) ◽  
pp. 1352-1363 ◽  
Author(s):  
Bruce A C Cree ◽  
Jeffrey L Bennett ◽  
Ho Jin Kim ◽  
Brian G Weinshenker ◽  
Sean J Pittock ◽  
...  
Keyword(s):  
Neuromyelitis Optica ◽  
Spectrum Disorder ◽  
Neuromyelitis Optica Spectrum Disorder ◽  
Phase 2 ◽  
Double Blind
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