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Cited by 513Multiple Sclerosis Research StudiesPeripheral Neuropathies and DisordersPolyomavirus and related diseases

The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.

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

Open access
Traboulsee, Anthony, Greenberg, Benjamin M, Bennett, Jeffrey L, Szczechowski, Lech, Fox, Edward, Shkrobot, Svitlana, Yamamura, Takashi, Terada, Yusuke, Kawata, Yuichi, Wright, Padraig, Gianella-Borradori, Athos, Garren, Hideki, Weinshenker, Brian G·2020·The Lancet Neurology
DOI 10.1016/s1474-4422(20)30078-8PMC PMC7935419
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Abstract

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 seronegative NMOSD at 44 investigational sites in 13 countries. Eligible participants had experienced at least one documented NMOSD attack or relapse in the past 12 months and had a score of 6·5 or less on the Expanded Disability Status Scale. Exclusion criteria included clinical relapse 30 days or fewer before baseline. Participants were randomly assigned (2:1) to receive satralizumab 120 mg or visually matched placebo subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. Taking immunosuppressants concomitantly was prohibited. The primary endpoint was time to the first protocol-defined relapse, based on the intention-to-treat population and analysed with stratification for two randomisation factors (previous therapy for prevention of attacks and nature of the most recent attack). Safety was assessed in all participants who received at least one dose of satralizumab or placebo. The double-blind phase was due to last until 44 protocol-defined relapses occurred or 1·5 years after random assignment of the last patient enrolled, whichever occurred first; participants could enter an open-label phase after the occurrence of a protocol-defined relapse or at the end of the double-blind phase. The study is registered with ClinicalTrials.gov, NCT02073279. Findings 95 (57%) of 168 screened participants were randomly assigned to treatment (63 to satralizumab; 32 to placebo) between Aug 5, 2014, and April 2, 2017. Protocol-defined relapses occurred in 19 (30%) patients receiving satralizumab and 16 (50%) receiving placebo (hazard ratio 0·45, 95% CI 0·23-0·89; p=0·018). 473·9 adverse events per 100 patient-years occurred in the satralizumab group, as did 495·2 per 100 patient-years in the placebo group; the incidence of serious adverse events and adverse events leading to withdrawal was similar between groups. Interpretation Satralizumab monotherapy reduced the rate of NMOSD relapse compared with placebo in the overall trial population, with a favourable safety profile. The patient population included a ratio of aquaporin-4 antibody seropositive and seronegative patients that was reflective of clinical practice. Satralizumab has the potential to become a valuable treatment option for patients with NMOSD. Funding Chugai Pharmaceutical (Roche).

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  1. Williamson M, McEnany M, Maxion-Bergemann S, Ong R. Epidemiologic temporal trends of neuromyelitis optic spectrum disorder in the United States from 2000 to 2015. 34th International Conference on Pharmacoepidemiology and Therapeutic Risk Management. Prague, Czech Republic; Aug 22–26, 2018.

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Metadata

Authors
Traboulsee, A., Greenberg, B. M., Bennett, J. L., Szczechowski, L., Fox, E., Shkrobot, S., Yamamura, T., Terada, Y., Kawata, Y., Wright, P., Gianella-Borradori, A., Garren, H., & Weinshenker, B. G.
Affiliations
  • University of British Columbia (CA)
  • The University of Texas Southwestern Medical Center (US)
  • University of Colorado Anschutz (US)
  • Medical University of Silesia (PL)
  • Central Texas Neurology Consultants (US)
  • National Center of Neurology and Psychiatry (JP)
  • Chugai Pharmaceutical Co., Ltd. (Japan) (JP)
  • Genentech (US)
  • Mayo Clinic (US)
Corresponding author
Traboulsee, Anthony
ORCID
Venue
The Lancet Neurology
Publisher
Elsevier BV
Published
2020-05
Volume
19
Issue
5
Pages
402-412
ISSN
1474-4422 (ISSN-L)
DOI
10.1016/s1474-4422(20)30078-8
PMC
PMC7935419
OpenAlex
W3018886418
Cited by
513
References
28
Citations by year
2026: 79 · 2025: 86 · 2024: 75 · 2023: 68 · 2022: 91 · 2021: 80 · 2020: 32
FWCI
44.55
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet Neurology (acceptedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • Bayer
  • Mitsubishi Tanabe Pharma Corporation
  • Teva Pharmaceutical Industries
  • Genentech
  • Guthy-Jackson Charitable Foundation
  • Novartis
  • Chugai Pharmaceutical
  • Roche
  • Japan Blood Products Organization
  • National Multiple Sclerosis Society
  • MedImmune
  • Patient-Centered Outcomes Research Institute
  • National Institutes of Health
  • Biogen
Topics
  • Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
  • Health Sciences › Medicine › Clinical Neurology › Peripheral Neuropathies and Disorders
  • Health Sciences › Medicine › Oncology › Polyomavirus and related diseases
Keywords
satralizumab, neuromyelitis optica spectrum disorder, IL-6 receptor, monotherapy, relapse prevention, aquaporin-4 antibodies, seronegative NMOSD, Expanded Disability Status Scale, safety, efficacy, monoclonal antibodies, open-label extension, relapse rate, disability progression, treatment discontinuation, adverse events, immunosuppressants
MeSH terms
Adolescent, Adult, Aged, Double-Blind Method, Female, Humans, Immunosuppressive Agents, Male, Middle Aged, Neuromyelitis Optica, Treatment Outcome, Young Adult, Antibodies, Monoclonal, Humanized

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