Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial
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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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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, depletion of CD19/CD20 memory B cells, as well as exacerbation of disease by b-IFN.
“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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Spectrum of sublytic astrocytopathy in neuromyelitis optica
Guo, Y., Lennon, V. A., Parisi, J. E., Popescu, B. F. G., Vasquez, C., Pittock, S. J., Howe, C. L., & Lucchinetti, C. F. (2021) · Brain · doi:10.1093/brain/awab394 · Cited by 52 · see citing works
Targeting cytokine networks in neuroinflammatory diseases
Becher, B., Derfuss, T. J., & Liblau, R. (2024) · Nature Reviews Drug Discovery · doi:10.1038/s41573-024-01026-y · Cited by 53 · see citing works
“One trial evaluated satralizumab as monotherapy and the other as add-on therapy to other basal immune-targeting drugs 140,141 .”
Role of Serum IL‐6 in Neuropsychiatric Systemic lupus Erythematosus
Hirohata, S., & Kikuchi, H. (2021) · ACR Open Rheumatology · doi:10.1002/acr2.11217 · Cited by 50 · see citing works
“In fact, it has been recently demonstrated that monoclonal antibodies to human IL-6 receptor, such as satralizumab and tocilizumab, reduced the risk of relapse in patients with NMOSD in randomized, multicenter, open-labeled trials (30,31), confirming the critical role of IL-6 signaling in the pathogenesis.”
BackgroundMonoclonal Antibody Therapies Beyond Complement for NMOSD and MOGAD
Redenbaugh, V., & Flanagan, E. P. (2022) · Neurotherapeutics · doi:10.1007/s13311-022-01206-x · Cited by 50 · see citing works
“SAkuraStar Trial Design This was an international, randomized, double-blind, placebo-controlled, phase 3 trial [140].”
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Cytokine dynamics and targeted immunotherapies in autoimmune encephalitis
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Kastrati, K., Aletaha, D., Burmester, G. R., Chwala, E., Dejaco, C., Dougados, M., McInnes, I. B., Ravelli, A., Sattar, N. A., Stamm, T., et al. (2022) · RMD Open · doi:10.1136/rmdopen-2022-002359 · Cited by 49 · see citing works
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“During the phase III controlled trials, SAkuraStar (satralizumab monotherapy vs placebo) 29 and SAkuraSky (satralizumab as add-on immunotherapy vs placebo), 30 common infections were observed in both treatment arms (see Table 1), with no clear increased infectious risk among those treated with…”
Self-citationTargeting B cells to modify MS, NMOSD, and MOGAD
Graf, J., Mareš, J., Barnett, M. H., Aktaş, O., Albrecht, P., Zamvil, S. S., & Hartung, H.-P. (2021) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000000919 · Cited by 48 · see citing works
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Magnetic resonance imaging in neuromyelitis optica spectrum disorder
Clarke, L., Arnett, S., Lilley, K., Liao, J., Bhuta, S., & Broadley, S. (2021) · Clinical & Experimental Immunology · doi:10.1111/cei.13630 · Cited by 46 · see citing works
“Phases II/III clinical trials of inebilizumab (antiCD19 B- cell depletory) [52], satralizumab (anti- IL- 6) [53] and eculizumab (anti- complement 5) [54] monoclonal antibodies have all shown positive results in NMOSD.”
BackgroundA meta‐analysis comparing first‐line immunosuppressants in neuromyelitis optica
Giovannelli, J., Ciron, J., Cohen, M., Kim, H., Kim, S., Stellmann, J., Kleiter, I., McCreary, M., Greenberg, B. M., Deschamps, R., et al. (2021) · Annals of Clinical and Translational Neurology · doi:10.1002/acn3.51451 · Cited by 46 · see citing works
Self-citationMonoclonal Antibody Engineering and Design to Modulate FcRn Activities: A Comprehensive Review
Ramdani, Y., Lamamy, J., Watier, H., & Gouilleux‐Gruart, V. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23179604 · Cited by 46 · see citing works
“Two anti-C5 mAbs derived from eculizumab (ravulizumab and crovalimab) with LS and M428L/N434A mutations, respectively [59,60], and a humanized anti-IL6R IgG2 mAb (satralizumab) with an N434A mutation have been successfully developed [29,61,62].”
BackgroundSongwisit, S., Kosiyakul, P., Jitprapaikulsan, J., Prayoonwiwat, N., Ungprasert, P., & Siritho, S. (2020) · Scientific Reports · doi:10.1038/s41598-020-73882-8 · Cited by 43 · see citing works
Schindler, P., Aktaş, O., Ringelstein, M., Wildemann, B., Jarius, S., Paul, F., & Ruprecht, K. (2022) · Expert Review of Clinical Immunology · doi:10.1080/1744666x.2023.2148657 · Cited by 42 · see citing works
Kraker, J. A., & Chen, J. J.-W. (2023) · Journal of Neurology · doi:10.1007/s00415-023-11920-x · Cited by 39 · see citing works
D'Souza, R., Wuebbolt, D., Andrejevic, K., Ashraf, R., Nguyen, V., Zaffar, N., Rotstein, D., & Wyne, A. (2020) · Frontiers in Neurology · doi:10.3389/fneur.2020.544434 · Cited by 36 · see citing works
Marignier, R., Pittock, S. J., Paul, F., Kim, H. J., Bennett, J. L., Weinshenker, B. G., Wingerchuk, D. M., Green, A., Fujihara, K., Cutter, G., et al. (2021) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2021.103356 · Cited by 39 · see citing works
“Furthermore, some of the historical NMOSD diagnoses in AQP4− patients may be erroneous owing to similarities in presentation to other diseases such as MS, sarcoidosis, infection, and lymphoma (Trebst et al., 2011).”
BackgroundSelf-citationHümmert, M. W., Schöppe, L. M., Bellmann-Strobl, J., Siebert, N., Paul, F., Duchow, A., Pellkofer, H., Kümpfel, T., Havla, J., Jarius, S., et al. (2022) · Neurology · doi:10.1212/wnl.0000000000200052 · Cited by 39 · see citing works
Advances in the Treatment of Neuromyelitis Optica Spectrum Disorder
Wallach, A. I., Tremblay, M. A., & Kister, I. (2020) · Neurologic Clinics · doi:10.1016/j.ncl.2020.09.003 · Cited by 38 · see citing works
“These strategies have now been rigorously proved in randomized clinical trials to decrease the relapse rate in NMOSD by 74% to 94%.(6,7,61) The older immunosuppressants and corticosteroids are still widely used for NMOSD, especially in resource-limited settings but will likely be increasingly replaced by the newer, mo…”
BackgroundAdverse Events in NMOSD Therapy
Giglhuber, K., & Berthele, A. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23084154 · Cited by 38 · see citing works
“In the TANGO trial, five SAEs occurred (in 59 patients = 8%), including severe pneumonia, herpes zoster, deep vein thrombosis, cerebral haemorrhage, and myelitis, none with a fatal outcome.”
BackgroundInfluentialNeuromyelitis Optica Spectrum Disorders
Costello, F. (2022) · CONTINUUM Lifelong Learning in Neurology · doi:10.1212/con.0000000000001168 · Cited by 38 · see citing works
IL-6 Signaling in Immunopathology: From Basic Biology to Selective Therapeutic Intervention
Schumertl, T., Lokau, J., & Garbers, C. (2025) · ImmunoTargets and Therapy · doi:10.2147/itt.s485684 · Cited by 40 · see citing works
“The newest addition is satralizumab, which showed promising results in phase 3 trials 109,110 and is approved for the treatment of neuromyelitis optica spectrum disorder.”
Eculizumab Use in Neuromyelitis Optica Spectrum Disorders
Ringelstein, M., Asseyer, S., Lindenblatt, G., Fischer, K., Pul, R., Škuljec, J., Lohmann, L., Giglhuber, K., Häußler, V., Karenfort, M., et al. (2024) · Neurology · doi:10.1212/wnl.0000000000209888 · Cited by 37 · see citing works
Habib, A. A., Zhao, C., Aban, I., França, M. C., José, J. G., zu Hörste, G. M., Klimiec, E., Pulley, M., Tavolini, D., Krumova, P., et al. (2025) · The Lancet Neurology · doi:10.1016/s1474-4422(24)00514-3 · Cited by 37 · see citing works
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“(ISTs) and as a monotherapy agent (SAkuraStar) [16, 17].”
BackgroundNeuromyelitis Optica Spectrum Disorder Treatment—Current and Future Prospects
Waliszewska‐Prosół, M., Chojdak-Łukasiewicz, J., Budrewicz, S. P., & Pokryszko‐Dragan, A. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22062801 · Cited by 35 · see citing works
“The safety profile and tolerability of satralizumab were good, without remarkable adverse events [16,68].”
BackgroundInebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder
Nie, T., & Blair, H. A. (2022) · CNS Drugs · doi:10.1007/s40263-022-00949-7 · Cited by 34 · see citing works
A STAT3 inhibitor ameliorates CNS autoimmunity by restoring Teff:Treg balance
Aqel, S. I., Yang, X. T., Kraus, E. E., Song, J., Farinas, M. F., Zhao, E. Y., Pei, W., Lovett‐Racke, A. E., Racke, M. K., Li, C., et al. (2021) · JCI Insight · doi:10.1172/jci.insight.142376 · Cited by 32 · see citing works
“Similarly, another αIL-6R mAb, satralizumab, was recently approved for the treatment of neuromyelitis optica, another human inflammatory demyelinating disease (64).”
BackgroundHuang, W., Wang, L., Xia, J., Li, W., Wang, M., Yu, J. Y., Li, Q., Wang, B., Pan, J., Du, L., et al. (2022) · European Journal of Neurology · doi:10.1111/ene.15355 · Cited by 32 · see citing works
B cell targeted therapies in inflammatory autoimmune disease of the central nervous system
Furman, M. J., Meuth, S. G., Albrecht, P., Dietrich, M., Blum, H., Mareš, J., Milo, R., & Hartung, H. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1129906 · Cited by 31 · see citing works
“Again, no robust difference between the substances could be objectified with regard to pain and fatigue (116).”
BackgroundHäußler, V., Trebst, C., Engels, D., Pellkofer, H., Havla, J. B., Duchow, A. S., Schindler, P., Schwake, C., Pakeerathan, T., Fischer, K., et al. (2024) · Journal of Neurology Neurosurgery & Psychiatry · doi:10.1136/jnnp-2024-334764 · Cited by 31 · see citing works
“5 6 12 Recently, eculizumab, inebilizumab, ravulizumab and satralizumab have been approved for the treatment of AQP4-IgG seropositive NMOSD, 13–17 but head- to-head comparisons among each other and with established off-label therapies are missing.”
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Neuromyelitis Optica Spectrum Disorder With Anti-Aquaporin-4 Antibody: Outcome Prediction Models
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Drug Treatment of Neuromyelitis Optica Spectrum Disorders: Out with the Old, in with the New?
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SARS-CoV-2 and Multiple Sclerosis: Potential for Disease Exacerbation
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Structural insights into IL-6 signaling inhibition by therapeutic antibodies
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Interleukin-6: evolving role in the management of neuropathic pain in neuroimmunological disorders
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“Traboulsee et al, 2020 (CT) [25] 95 patients with AQP4-Ab- seropositive or AQP4Ab-seronegative NMOSD: satralizumab,63; placebo, 32 Previous: B-cell depleting therapy and immunosuppressants.”
Meca-Lallana, J. E., Gómez-Ballesteros, R., Miralles, F. C. P., Forero, L., Sepúlveda, M., Calles, C., Martínez‐Ginés, M. L., González‐Suarez, I., Boyero, S., Romero-Pinel, L., et al. (2022) · Neurology and Therapy · doi:10.1007/s40120-022-00356-6 · Cited by 28 · see citing works
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Current perspectives on the diagnosis and management of acute transverse myelitis
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“efficacy of satralizumab as a monotherapy [193,194].”
Sechi, E. (2024) · CONTINUUM Lifelong Learning in Neurology · doi:10.1212/con.0000000000001454 · Cited by 27 · see citing works
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Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis
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“The safety and efficacy of satralizumab were evaluated in the SAkuraSky and SAkuraStar trials, phase III, randomized, double-blind, placebo-controlled, time-to-event studies of AQP4-seropositive (70%) and AQP4-seronegative patients (30%) with NMOSD [142,143].”
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Burden and cost of comorbidities in patients with neuromyelitis optica spectrum disorder
Exuzides, A., Sheinson, D. M., Sidiropoulos, P. N. M., Magrini, F., Gholizadeh, S., Surinach, A., Cook, L. J., Meyer, C. S., & Yeaman, M. R. (2021) · Journal of the Neurological Sciences · doi:10.1016/j.jns.2021.117530 · Cited by 25 · see citing works
- 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 › Pathology and Forensic Medicine › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › 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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