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)

Bennett, Jeffrey L.; Greenberg, Benjamin; Traboulsee, Anthony; Szczechowski, L; Fox, Edward J.; Shkrobot, Svitlana; Yamamura, Takashi; Terada, Yayoi; Kawata, Yuichi; Büdingen, H.-Christian von; Klingelschmitt, Gaëlle; Gianella‐Borradori, Athos; Weinshenker, Brian G.

doi:10.1016/j.jns.2019.10.1109

Cited by 7 publications

(7 citation statements)

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“…Studies that emphasize the efficacy of anti-interleukin 6 receptor antibodies, e.g., sartralizumab and tocilizumab, underline the importance of interleukin 6 as a B cell-activating factor in NMOSD. [29][30][31] MOGAD MOG, myelin oligodendrocyte glycoprotein, is a minor component of CNS myelin expressed on its outer layer. Conformation-dependent antibodies have been described in a number of CNS inflammatory disease, but recent evidence suggests that MOG IgG-associated disease (MOGAD), affecting children and adults, is a distinct clinical and pathologic entity with optic neuritis, myelitis, isolated brainstem, encephalitis, encephalopathic, or acute disseminated encephalomyelitis-like presentation.…”

Section: Rituximabmentioning

confidence: 99%

Targeting B cells to modify MS, NMOSD, and MOGAD

Graf

Mareś

Barnett

et al. 2021

Neurol Neuroimmunol Neuroinflamm

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Ocrelizumab, rituximab, ofatumumab, ublituximab, inebilizumab, and evobrutinib are immunotherapies that target various B cell–related proteins. Most of these treatments have proven efficacy in relapsing and progressive forms of MS and neuromyelitis optica spectrum disease (NMOSD) or are in advanced stages of clinical development. Currently, ocrelizumab and inebilizumab are licensed for treatment of MS and NMOSD, respectively. This part of the review focuses on monoclonal antibody B cell–depleting strategies in NMOSD and the emerging related myelin oligodendrocyte glycoprotein (MOG) immunoglobulin G–associated disease (MOGAD). Case series and phase 2/3 studies in these inflammatory disorders are assessed. The safety profile of long-term B-cell depletion in MS, NMOSD, and MOGAD will be highlighted. Finally implications of the current coronavirus disease 2019 pandemic on the management of patients with these disorders and the use of B cell–depleting agents will be discussed.

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Section: Rituximabmentioning

confidence: 99%

Targeting B cells to modify MS, NMOSD, and MOGAD

Graf

Mareś

Barnett

et al. 2021

Neurol Neuroimmunol Neuroinflamm

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“…The main pathological mechanism involved in the background to NMO is associated with autoreactive anti-AQP4 IgG antibodies. Their relevant role has been confirmed in experimental models (NMO pathology was induced in rats after recombinant IgG transfer) as well as in clinical studies (anti-AQP4 IgG level correlated with relapse activity and the extent of spinal cord lesions shown in MRI) [ 15 , 16 , 17 ].…”

Section: Pathogenesis Of Nmodsmentioning

confidence: 96%

“…In both trials clear differences in the disease outcomes were observed between subjects who were seropositive and seronegative for anti-AQP4 Ig, with a disadvantage for the latter. The safety profile and tolerability of satralizumab were good, without remarkable adverse events [ 16 , 68 ]. In 2020 satralizumab was also approved by the FDA as the therapy for seropositive NMO patients.…”

Section: Current Nmods Treatmentmentioning

confidence: 99%

Neuromyelitis Optica Spectrum Disorder Treatment—Current and Future Prospects

Waliszewska‐Prosół

Chojdak-Łukasiewicz

Budrewićz

et al. 2021

IJMS

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Neuromyelitis optica (NMO) is an immune-mediated demyelinative disorder of the central nervous system affecting mainly the optical nerves and the spinal cord. The recurrent course of the disease, with exacerbations and incomplete remissions, causes accumulating disability, which has a profound impact upon patients’ quality of life. The discovery of antibodies against aquaporin 4 (AQP4) and their leading role in NMO etiology and the formulation of diagnostic criteria have improved appropriate recognition of the disease. In recent years, there has been rapid progress in understanding the background of NMO, leading to an increasing range of treatment options. On the basis of a review of the relevant literature, the authors present currently available therapeutic strategies for NMO as well as ongoing research in this field, with reference to key points of immune-mediated processes involved in the background of the disease.

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“…More recently, results have become available for satralizumab monotherapy in NMOSD. In the SAkuraStar study, the efficacy and safety of satralizumab was compared to placebo for relapse prevention in patients with NMOSD [47]. In this phase 3, double-blind, placebo-controlled study, 95 patients were randomised 2:1 to satralizumab (120 mg s.c.) or placebo, administered at weeks 0, 2, 4 and every four weeks thereafter.…”

Section: Satralizumabmentioning

confidence: 99%

Novel emerging treatments for NMOSD

Selmaj

Selmaj²

2019

Neurol Neurochir Pol.

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Neuromyelitis optica spectrum disorders (NMOSD) are inflammatory demyelinating diseases of the central nervous system (CNS) that cause optic neuritis, transverse myelitis, and some other CNS syndromes. Recently, diagnosis and understanding of these diseases has been markedly enhanced by the discovery that serum autoantibodies that target aquaporin-4 (AQP4) are strongly associated with the disease. This spectrum includes also a potential subset of patients with a phenotype of NMOSD who have anti-myelin oligodendrocyte glycoprotein (MOG) antibody. Although steroids and immunosuppressive drugs have been widely used for NMOSD treatment, until recently there was no approved therapy for these diseases. With improved understanding of the pathophysiology of NMOSD, numerous new therapeutic strategies have recently been evaluated. The results of these studies, involving monoclonal antibodies (mAbs) inhibiting terminal complement protein cleavage interfering with interleukin-6 receptor (IL-6 R) signaling and depleting CD19-positive B cells, have been published in recent months. All of these new therapeutics have shown a high degree of efficacy in diminishing NMOSD activity and inhibiting disability progression. At the same time, all these mAbs have demonstrated favorable safety and tolerability profiles, with a limited rate of adverse events. The first of these new drugs, eculizumab, have been approved in USA and Europe for NMOSD treatment within the last couple of months and it is expected that the other novel, effective and safe treatments for NMOSD will be approved in the near future.

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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)

Abstract: Poster Session 2Efficacy 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)

Cited by 7 publications

References 0 publications

Targeting B cells to modify MS, NMOSD, and MOGAD

Targeting B cells to modify MS, NMOSD, and MOGAD

Neuromyelitis Optica Spectrum Disorder Treatment—Current and Future Prospects

Novel emerging treatments for NMOSD

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