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

@article{Traboulsee2020SafetyAE,
  title={Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial},
  author={Anthony L. Traboulsee and Benjamin M. Greenberg and Jeffrey L. Bennett and Lech Szczechowski and Edward J. Fox and Svitlana Shkrobot and Takashi Yamamura and Yusuke Terada and Yuichi Kawata and P{\'a}draig Wright and Athos Gianella-Borradori and Hideki Garren and Brian G. Weinshenker},
  journal={The Lancet Neurology},
  year={2020},
  volume={19},
  pages={402-412}
}
BACKGROUND Satralizumab, a humanised monoclonal antibody targeting the interleukin-6 receptor, reduced the risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) when added to immunosuppressant therapy. This study assessed the safety and efficacy of satralizumab monotherapy in patients with the disorder. METHODS In this phase 3, double-blind, placebo-controlled, parallel-group trial, we enrolled adults aged 18-74 years with aquaporin-4 antibody seropositive or… Expand
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TLDR
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References

SHOWING 1-10 OF 29 REFERENCES
Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial
TLDR
Compared with placebo, inebilizumab reduced the risk of an NMOSD attack and has potential application as an evidence-based treatment for patients withNMOSD. Expand
Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder.
TLDR
Among patients with NMOSD, satralizumab added to immunosuppressant treatment led to a lower risk of relapse than placebo but did not differ from placebo in its effect on pain or fatigue. Expand
Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder.
TLDR
Patients with AQP4-IgG-positive NMOSD who received eculizumab had a significantly lower risk of relapse than those who received placebo, and there was no significant between-group difference in measures of disability progression. Expand
Present and Future Therapies in Neuromyelitis Optica Spectrum Disorders
TLDR
Present and future immunotherapies for NMOSD are discussed and combination of treatments, plasma, cellular and other therapies are considered and current advances in immunopathological knowledge are translated into innovative concepts and begin a new era ofNMOSD therapy. Expand
Treatment of neuromyelitis optica: state-of-the-art and emerging therapies
TLDR
Current NMO treatments include general immunosuppressive agents, B-cell depletion, and plasma exchange, and therapeutic strategies targeting complement proteins, the IL-6 receptor, neutrophils, eosinophils and CD19—all initially developed for other indications—are under clinical evaluation for repurposing for NMO. Expand
Neuromyelitis optica spectrum disorders
TLDR
In patients with AQP4-IgG, the similar outcomes regardless of the clinical phenotype support the unified term NMOSD; nonwhite ethnicity and older age at onset are associated with worse outcome. Expand
The Treatment of Neuromyelitis Optica
  • M. Kowarik, J. Soltys, J. Bennett
  • Medicine
  • Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society
  • 2014
TLDR
The goal of this review is to familiarize the reader with biologic and clinical data supporting current treatments in NMO and highlight future strategies based on advancements in understanding of NMO pathogenesis. Expand
Neuromyelitis optica: clinical features, immunopathogenesis and treatment
TLDR
The widening clinical spectrum of AQP4‐related autoimmunity, the role of magnetic resonance imaging (MRI) and new diagnostic means such as optical coherence tomography in the diagnosis of NMO are discussed and prospects for new and emerging therapies for this rare, but often devastating condition are outlined. Expand
Characteristic Cerebrospinal Fluid Cytokine/Chemokine Profiles in Neuromyelitis Optica, Relapsing Remitting or Primary Progressive Multiple Sclerosis
TLDR
In NMO, over-expression of a cluster of Th17- and Th1-related proinflammatory cytokines/chemokines is characteristic, while in PPMS, increased CCL4 and CXCL10 levels may reflect on-going low grade T cell and macrophage/microglia inflammation in the central nervous system. Expand
Epidemiology of Neuromyelitis Optica in the World: A Systematic Review and Meta-Analysis
TLDR
A systematic review and assessment of the quality of studies reporting the incidence and/or prevalence of NMO across the world reveals the gaps that still exist in the epidemiological knowledge of N MO in the world. Expand
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