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Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial
Open accessAbstract
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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“In any case, the long-term persistence of (re-)activatable autoantigen-specific ThEx cells in patients in remission may well explain the less-than-perfect treatment efficacy of steroid-sparing agents, 64-67 depletion of CD19/CD20 memory B cells, 68,69 as well as exacerbation of disease by b -IFN. 27,70”
From Autoantigen-specific CD4+ T cells acquire an exhausted phenotype and persist in human antigen-specific autoimmune diseases (2024) · cites this paper as [67]
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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)
- 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
- bronze
- doi.org
- Licence
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- www.elsevier.com/legal/tdmrep-license (tdm)
- www.elsevier.com/open-access/userlicense/1.0/ (am, 356 d)
- doi.org/10.15223/policy-017 (stm-asf)
- doi.org/10.15223/policy-037 (stm-asf)
- doi.org/10.15223/policy-012 (stm-asf)
- doi.org/10.15223/policy-029 (stm-asf)
- doi.org/10.15223/policy-004 (stm-asf)
- 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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