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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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“More recently, the first treatments for NMOSD have been approved by regulatory agencies, based on results of phase III randomised controlled clinical trials: satralizumab (Enspryng®) [16], a monoclonal antibody against the IL-6R, eculizumab (Soliris®) [17], an anti-C5 complement inhibitor and inebilizumab (Uplinza®) […”
BackgroundMethodAssociation of subcortical structural shapes with fatigue in neuromyelitis optica spectrum disorder
Seok, J. M., Cho, W., Son, D.-H., Shin, J. H., Cho, E. B., Kim, S. T., Kim, B. J., Seong, J., & Min, J. (2022) · Scientific Reports · doi:10.1038/s41598-022-05531-1 · Cited by 12
Min, J., Capobianco, M. A. N., Welsh, C., Lobo, P., deFiebre, G., Lana–Peixoto, M. A., Wingerchuk, D. M., Wang, J., & Ringelstein, M. (2023) · Neurology and Therapy · doi:10.1007/s40120-022-00431-y · Cited by 12
Advances in the treatment of neuromyelitis optic spectrum disorder
Yang, X., Zhang, S., Feng, J., & Qin, X. (2025) · Therapeutic Advances in Neurological Disorders · doi:10.1177/17562864251328276 · Cited by 11
“47,48 The SAkura-Sky trail included 83 NMOSD patients aged 12–74, randomly assigned in 1:1 to the satralizumab or placebo group.”
Neuromyelitis Optica Spectrum Disorders: Clinical Perspectives, Molecular Mechanisms, and Treatments
Thangaleela, S., Sivamaruthi, B. S., Radha, A., Kesika, P., & Chaiyasut, C. (2023) · Applied Sciences · doi:10.3390/app13085029 · Cited by 14
Eliseeva, D. D., & Zakharova, M. N. (2023) · Biochemistry (Moscow) · doi:10.1134/s0006297923040107 · Cited by 12
“Clinical studies have shown that a humanized monoclonal antibody inhibiting the IL-6 signaling pathway significantly reduced the risk of recurrence in AQP4-IgG positive NMOSD patients [62].”
BackgroundNew advancements in the management of Neuromyelitis Optica spectrum disease: literature review
Sudhakar, P., Abusamra, K., Ajjeya, M. T., & Kini, T. A. (2023) · Frontiers in Ophthalmology · doi:10.3389/fopht.2023.1130971 · Cited by 11
Neuromyelitis Optica Spectrum Disorder in Latin America: State-of-the-Art and Current Challenges
Contentti, E. C., Eizaguirre, B., López, P. A., Silva, B. A., Tkachuk, V. A., Tizio, S., & Alonso, R. N. (2024) · Journal of Integrative Neuroscience · doi:10.31083/j.jin2304074 · Cited by 11
Induction of immune tolerance in NMOSD and MOGAD
Correale, J. D., & Contentti, E. C. (2025) · Therapeutic Advances in Neurological Disorders · doi:10.1177/17562864251357393 · Cited by 11
“94,95 However, a critical caveat in interpreting these findings is the limited representation of DN-NMOSD patients within these studies, precluding definitive conclusions regarding the pathogenic relevance of complement and IL-6 pathways in this population.”
Kim, H. J., Nakashima, I., Viswanathan, S., Wang, K., Shang, S., Miller, L., Yountz, M., Wingerchuk, D. M., Pittock, S. J., Levy, M., et al. (2021) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2021.102849 · Cited by 11
Akaishi, T., Takahashi, T., Fujihara, K., Misu, T., Fujimori, J., Takai, Y., Nishiyama, S., Abe, M., Ishii, T., Aoki, M., et al. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.608149 · Cited by 12
Hasegawa, Y., Arinuma, Y., Muramatsu, T., Kondou, J., Matsueda, Y., Kanayama, Y., Ino, K., Tanaka, T., Wada, T., Oku, K., et al. (2023) · Lupus · doi:10.1177/09612033231151600 · Cited by 11
Reshaping neuroimmunology: diagnosis and treatment in the era of precision medicine
dos Passos, G. R., Adoni, T., Mendes, M. F., & Sato, D. K. (2023) · Arquivos de Neuro-Psiquiatria · doi:10.1055/s-0043-1777752 · Cited by 12
Eculizumab in the Treatment of Neuromyelitis Optica Spectrum Disorder
Giglhuber, K., & Berthele, A. (2020) · Immunotherapy · doi:10.2217/imt-2020-0163 · Cited by 11
Traub, J., Husseini, L., & Weber, M. S. (2021) · Pharmaceuticals · doi:10.3390/ph14010037 · Cited by 11
“NCT02073279 3 2014 n/a Satralizumab IL-6 receptor 95 active, not recruiting [119] Section 3.”
BackgroundJuryńczyk, M., Klimiec, E., Kong, Y., Hurley, S. A., Messina, S., Yeo, T., Jenkinson, M., Leite, M. I., & Palace, J. A. (2021) · Journal of Neurology · doi:10.1007/s00415-021-10619-1 · Cited by 13
Contentti, E. C., López, P. A., & Rojas, J. I. (2022) · Expert Opinion on Emerging Drugs · doi:10.1080/14728214.2022.2059463 · Cited by 11
Demystifying MOGAD and Double Seronegative NMOSD Further With IL-6 Blockade
Yong, K. P., & Kim, H. J. (2021) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000001110 · Cited by 11
Saudi consensus recommendations on the management of Neuromyelitis Optica Spectrum Disorders (NMOSD)
Shosha, E., Aljarallah, S., Fugham, N. A., Al-Jedai, A. H., Alluqmani, M. M., Malik, Y. M. A., Mudaiheem, H. Y. A., Alotaibi, H., Althekair, F. Y., Althubaiti, I. A., et al. (2022) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2022.104062 · Cited by 10
Li, X., Wu, W., Zeng, Y., Wu, W., Hou, C., Zhu, H., Liao, Y., Tian, Y., Chen, Z., Peng, B., et al. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1257955 · Cited by 10
Xue, T., Yu, J., Chen, S., Wang, Z., Yang, Y., Chen, Z., & Wang, Z. (2020) · Frontiers in Neurology · doi:10.3389/fneur.2020.604445 · Cited by 10
Can Immune Tolerance Be Re-established in Neuromyelitis Optica?
Loda, E., Arellano, G., Perez-Giraldo, G., Miller, S. D., & Balabanov, R. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.783304 · Cited by 10
Yao, X., Xie, L. H., Cai, Y. C., Zhang, Y., Deng, Y., Gao, M., Wang, Y., Xu, H., Gao, W., Ding, J., et al. (2022) · Frontiers in Neurology · doi:10.3389/fneur.2022.860083 · Cited by 10
Advances in Antibody-Based Therapeutics for Cerebral Ischemia
Sun, J., Yen, T., Jan, J., Mwale, P. F., Teng, R.-D., Taliyan, R., Hsieh, C.-T., & Yang, C. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics15010145 · Cited by 11
“The approval of Satralizumab as a disease-modifying medication for anti-AQP4 seropositive NMOSD was based on the results of two phase III studies [64,65], making it the second humanized anti-IL-6 receptor IgG2 mAb to achieve this distinction.”
Uzunköprü, C., Tütüncü, M., Gündüz, T., Gümüş, H., Şen, S., Demir, S., Çınar, B. P., Türe, H. S., Uygunoğlu, U., Toğrol, E., et al. (2021) · International Journal of Clinical Practice · doi:10.1111/ijcp.14158 · Cited by 10
Сергеевич, К. В., Bakhtiyarova, K. Z., Evdoshenko, E. P., Korobko, D. S., Simaniv, T. O., Totolyan, N. A., Хачанова, Н. В., Shumilina, M. V., & Davydovskaya, M. V. (2022) · Neurology neuropsychiatry Psychosomatics · doi:10.14412/2074-2711-2022-6-139-148 · Cited by 10
Scholl, A. R., Korentzelos, D. K., Forns, T., Brenneman, E. K., Kelm, M. J., Datto, M., Wheeler, S., & Carlsen, E. D. (2022) · The Journal of Applied Laboratory Medicine · doi:10.1093/jalm/jfac064 · Cited by 9
“The advent of monoclonal antibody therapy has revolutionized large sectors of medicine, including oncology (16), neurology (17, 18), rheumatology (19), and, with the introduction of anti-COVID-19 therapies, infectious disease.”
BackgroundA Dual‐domain Engineered Antibody for Efficient HBV Suppression and Immune Responses Restoration
Jiang, Y., Chen, X., Ye, X., Wen, C., Xu, T., Yu, C., Ning, W., Wang, G., Xiang, X., Liu, X., et al. (2024) · Advanced Science · doi:10.1002/advs.202305316 · Cited by 7
Tisavipat, N., Juan, H. Y., & Chen, J. J.-W. (2023) · Saudi Journal of Ophthalmology · doi:10.4103/sjopt.sjopt_102_23 · Cited by 9
“[14,15] Both AQP4‑IgG+ and AQP4‑IgG‑negative NMOSD patients were included in these studies.”
BackgroundOverview and Diagnostic Approach in Autoimmune Neurology
McKeon, A. B., & Pittock, S. J. (2024) · CONTINUUM Lifelong Learning in Neurology · doi:10.1212/con.0000000000001447 · Cited by 11
Chen, B., Francis, A. G., Cooper, S. A., Dobson, R., Hacohen, Y., Halfpenny, C. A., Hemingway, C. A., Hobart, J. C., O’Sullivan, E. P., Rashid, W., et al. (2024) · Neurology · doi:10.1212/wnl.0000000000210137 · Cited by 11
Villacieros‐Álvarez, J., Espejo, C., Arrambide, G., Dinoto, A., Mulero, P., Rubio-Flores, L., Nieto, P., Alcalá, C., Lallana, J. E. M., Millán‐Pascual, J., et al. (2025) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000200362 · Cited by 9
Ravulizumab and other complement inhibitors for the treatment of autoimmune disorders
Vieira, G. D. D., Boldrini, V. D. O., Mader, S., Kümpfel, T., Meinl, E., & Damasceno, A. (2025) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2025.106311 · Cited by 15
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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