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 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).
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The cited source says what the claim attributes to it.
In the citing paper
“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]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
International consensus diagnostic criteria for neuromyelitis optica spectrum disorders
Wingerchuk, D. M., Banwell, B., Bennett, J. L., Cabre, P., Carroll, W., Chitnis, T., de Seze, J., Fujihara, K., Greenberg, B., Jacob, A., et al. (2015) · Neurology · doi:10.1212/wnl.0000000000001729 · Cited by 4,649
Self-citationRevised diagnostic criteria for neuromyelitis optica
Wingerchuk, D. M., Lennon, V. A., Pittock, S. J., Lucchinetti, C. F., & Weinshenker, B. G. (2006) · Neurology · doi:10.1212/01.wnl.0000216139.44259.74 · Cited by 2,568
Self-citationThe spectrum of neuromyelitis optica
Wingerchuk, D. M., Lennon, V. A., Lucchinetti, C. F., Pittock, S. J., & Weinshenker, B. G. (2007) · The Lancet Neurology · doi:10.1016/s1474-4422(07)70216-8 · Cited by 2,182
Self-citation(2003) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-1-79 · Cited by 1,506
Interleukin-6, a Major Cytokine in the Central Nervous System
Erta, M., Quintana, A., & Hidalgo, J. (2012) · International Journal of Biological Sciences · doi:10.7150/ijbs.4679 · Cited by 1,093
Eculizumab in Aquaporin-4–Positive Neuromyelitis Optica Spectrum Disorder
Pittock, S. J., Berthele, A., Fujihara, K., Kim, H. J., Levy, M., Palace, J. A., Nakashima, I., Terzi, M., Totolyan, N. A., Viswanathan, S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1900866 · Cited by 887
Physiological Roles of Aquaporin-4 in Brain
Nagelhus, E. A., & Ottersen, O. P. (2013) · Physiological Reviews · doi:10.1152/physrev.00011.2013 · Cited by 766
Cree, B. A. C., Bennett, J. L., Kim, H. J., Weinshenker, B. G., Pittock, S. J., Wingerchuk, D. M., Fujihara, K., Paul, F., Cutter, G. R., Marignier, R., et al. (2019) · The Lancet · doi:10.1016/s0140-6736(19)31817-3 · Cited by 756
Self-citationTrial of Satralizumab in Neuromyelitis Optica Spectrum Disorder
Yamamura, T., Kleiter, I., Fujihara, K., Palace, J. A., Greenberg, B. M., Zakrzewska‐Pniewska, B., Patti, F., Tsai, C., Saiz, A., Yamazaki, H., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1901747 · Cited by 663
Self-citationChihara, N., Aranami, T., Sato, W., Miyazaki, Y., Miyake, S., Okamoto, T., Ogawa, M., Toda, T., & Yamamura, T. (2011) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.1017385108 · Cited by 476
Self-citation
Research works printed but not linked: 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.
Cited by
Sorted by citations
Jarius, S., Paul, F., Weinshenker, B. G., Levy, M., Kim, H. J., & Wildemann, B. (2020) · Nature Reviews Disease Primers · doi:10.1038/s41572-020-0214-9 · Cited by 503
Self-citationNeuromyelitis optica spectrum disorders: from pathophysiology to therapeutic strategies
Contentti, E. C., & Correale, J. D. (2021) · Journal of Neuroinflammation · doi:10.1186/s12974-021-02249-1 · Cited by 363
Diagnosis and classification of optic neuritis
Petzold, A., Fraser, C. L., Abegg, M., Alroughani, R., Alshowaeir, D., Alvarenga, R., Andris, C., Asgari, N., Barnett, Y., Battistella, R., et al. (2022) · The Lancet Neurology · doi:10.1016/s1474-4422(22)00200-9 · Cited by 330
Kaplon, H., & Reichert, J. M. (2021) · mAbs · doi:10.1080/19420862.2020.1860476 · Cited by 301
“1% with placebo.(44) In the SAkuraSky study, which evaluated satralizumab when used concurrently with baseline IST, 91.”
BackgroundInterleukin 6: at the interface of human health and disease
Grebenciucova, E., & VanHaerents, S. A. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1255533 · Cited by 326
Zhang, C., Zhang, M., Qiu, W., Ma, H., Zhang, X., Zhu, Z., Yang, C.-S., Jia, D., Zhang, T.-X., Yuan, M., et al. (2020) · The Lancet Neurology · doi:10.1016/s1474-4422(20)30070-3 · Cited by 287
Self-citationKümpfel, T., Giglhuber, K., Aktaş, O., Ayzenberg, I., Bellmann–Strobl, J., Häußler, V., Havla, J. B., Hellwig, K., Hümmert, M. W., Jarius, S., et al. (2023) · Journal of Neurology · doi:10.1007/s00415-023-11910-z · Cited by 263
“The clinical onset of action for satralizumab is believed to be within 8–12 weeks, based on the results of the two clinical trials [223, 250].”
BackgroundInfluentialInterleukin-6 in neuromyelitis optica spectrum disorder pathophysiology
Fujihara, K., Bennett, J. L., Seze, J. D., Haramura, M., Kleiter, I., Weinshenker, B. G., Kang, D., Mughal, T., & Yamamura, T. (2020) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000000841 · Cited by 254
Self-citationNeuromyelitis Optica Spectrum Disorder
Wingerchuk, D. M., & Lucchinetti, C. F. (2022) · New England Journal of Medicine · doi:10.1056/nejmra1904655 · Cited by 220
Qin, C., Tian, D., Zhou, L., Shang, K., Huang, L., Dong, M., You, Y., Xiao, J., Xiong, Y., Wang, W., et al. (2023) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-022-01278-3 · Cited by 177
Ringelstein, M., Ayzenberg, I., Lindenblatt, G., Fischer, K., Gahlen, A., Novi, G., Hayward-Koennecke, H. K., Schippling, S., Rommer, P. S., Kornek, B., et al. (2021) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000001100 · Cited by 160
“Under TCZ therapy, most of the myelitis and ON attacks occurred in AQP4-IgG+ NMOSD and doubleseronegative patients (AQP4-IgG+ NMOSD: myelitis [14], ON [4]; MOGAD: myelitis [2], ON + myelitis [1]; double seronegatives: myelitis [4]).”
BackgroundNew therapies for neuromyelitis optica spectrum disorder
Levy, M., Fujihara, K., & Palace, J. A. (2020) · The Lancet Neurology · doi:10.1016/s1474-4422(20)30392-6 · Cited by 151
IL-6 Revisited: From Rheumatoid Arthritis to CAR T Cell Therapy and COVID-19
Kishimoto, T., & Kang, S. (2022) · Annual Review of Immunology · doi:10.1146/annurev-immunol-101220-023458 · Cited by 140
Hope for patients with neuromyelitis optica spectrum disorders — from mechanisms to trials
Pittock, S. J., Ζεκερίδου, Α., & Weinshenker, B. G. (2021) · Nature Reviews Neurology · doi:10.1038/s41582-021-00568-8 · Cited by 148
Self-citationNMOSD and MOGAD: an evolving disease spectrum
Uzawa, A., Oertel, F. C., Mori, M., Paul, F., & Kuwabara, S. (2024) · Nature Reviews Neurology · doi:10.1038/s41582-024-01014-1 · Cited by 128
“…(intravenously administered humanized monoclonal antibodies that inhibit the terminal complement cascade by blocking C5 cleavage); satralizumab 214,215 (a subcutaneously administered humanized monoclonal antibody that targets the soluble and membrane-bound IL-6 receptor and has a longer half-life…”
Seronegative autoimmune encephalitis: clinical characteristics and factors associated with outcomes
Lee, W., Lee, H.-S., Kim, D.-Y., Lee, H., Moon, J., Park, K., Lee, S. K., Chu, K., & Lee, S. (2022) · Brain · doi:10.1093/brain/awac166 · Cited by 126
Role of IL-6 in the commitment of T cell subsets
Korn, T., & Hiltensperger, M. (2021) · Cytokine · doi:10.1016/j.cyto.2021.155654 · Cited by 128
Barreras, P., Vasileiou, E. S., Filippatou, A. G., Fitzgerald, K. C., Levy, M., Pardo, C. A., Newsome, S. D., Mowry, E. M., Calabresi, P. A., & Sotirchos, E. S. (2022) · Neurology · doi:10.1212/wnl.0000000000201260 · Cited by 123
“Furthermore, our study included a high proportion of African Americans in the AQP4-IgG+ NMOSD group (51%), a population that is often underrepresented in clinical trials, including in the recent phase 3 clinical trials in NMOSD, and which has been proposed to be predisposed to developNMOSDand to experience worse clini…”
Teratoma Removal, Steroid, IVIG, Rituximab and Tocilizumab (T-SIRT) in Anti-NMDAR Encephalitis
Lee, W., Lee, S., Shin, Y., Lee, H. S., Shin, H., Kim, D.-Y., Kim, S., Lim, J.-A., Moon, J., Park, K., et al. (2020) · Neurotherapeutics · doi:10.1007/s13311-020-00921-7 · Cited by 118
Updates in NMOSD and MOGAD Diagnosis and Treatment
Cacciaguerra, L., & Flanagan, E. P. (2023) · Neurologic Clinics · doi:10.1016/j.ncl.2023.06.009 · Cited by 112
Staging of astrocytopathy and complement activation in neuromyelitis optica spectrum disorders
Takai, Y., Misu, T., Suzuki, H., Takahashi, T., Okada, H., Tanaka, S., Okita, K., Sasou, S., Watanabe, M., Namatame, C., et al. (2021) · Brain · doi:10.1093/brain/awab102 · Cited by 102
Haghikia, A., Schett, G. A., & Mougiakakos, D. (2024) · The Lancet Neurology · doi:10.1016/s1474-4422(24)00140-6 · Cited by 96
International Delphi Consensus on the Management of AQP4-IgG+ NMOSD
Paul, F., Marignier, R., Palace, J. A., Arrambide, G., Asgari, N., Bennett, J. L., Cree, B., Seze, J. D., Fujihara, K., Kim, H. J., et al. (2023) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000200124 · Cited by 91
Self-citationAsseyer, S., Cooper, G., & Paul, F. (2020) · Frontiers in Neurology · doi:10.3389/fneur.2020.00778 · Cited by 87
Heo, Y. (2020) · Drugs · doi:10.1007/s40265-020-01380-2 · Cited by 88
Aletaha, D., Kerschbaumer, A., Kastrati, K., Dejaco, C., Dougados, M., McInnes, I. B., Sattar, N. A., Stamm, T., Takeuchi, T., Trauner, M., et al. (2022) · Annals of the Rheumatic Diseases · doi:10.1136/ard-2022-222784 · Cited by 85
“71 ;73 Indeed, satralizumab, a humanised anti-IL-6R antibody, has proven efficacious in this disease and has been approved in the USA and Japan at a SC dose of 120 mg at weeks 0, 2, and 4 and every 4 weeks thereafter with or without immunosuppressive agents.”
Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension
Pittock, S. J., Fujihara, K., Palace, J. A., Berthele, A., Kim, H. J., Oreja‐Guevara, C., Nakashima, I., Levy, M., Shang, S., Yountz, M., et al. (2021) · Multiple Sclerosis Journal · doi:10.1177/13524585211038291 · Cited by 78
Saggau, C., Bacher, P., Esser, D., Rasa, M., Meise, S., Mohr, N., Kohlstedt, N., Hutloff, A., Schacht, S.-S., Dargvainiene, J., et al. (2024) · Immunity · doi:10.1016/j.immuni.2024.08.005 · Cited by 79
Sechi, E., & Flanagan, E. P. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.673339 · Cited by 79
A comprehensive review of the advances in neuromyelitis optica spectrum disorder
Siriratnam, P., Huda, S., Butzkueven, H., van der Walt, A., Jokubaitis, V., & Monif, M. (2023) · Autoimmunity Reviews · doi:10.1016/j.autrev.2023.103465 · Cited by 81
Time to Disability Milestones and Annualized Relapse Rates in NMOSD and MOGAD
Duchow, A. S., Bellmann–Strobl, J., Friede, T., Aktaş, O., Angstwurm, K., Ayzenberg, I., Berthele, A., Dawin, E., Engels, D., Fischer, K., et al. (2023) · Annals of Neurology · doi:10.1002/ana.26858 · Cited by 73
Chen, J. J.-W., Flanagan, E. P., Pittock, S. J., Stern, N. C., Tisavipat, N., Bhatti, M. T., Chodnicki, K. D., Tajfirouz, D. A., Jamali, S., Kunchok, A. C., et al. (2023) · American Journal of Ophthalmology · doi:10.1016/j.ajo.2023.02.013 · Cited by 84
Kleiter, I., Traboulsee, A. L., Palace, J. A., Yamamura, T., Fujihara, K., Saiz, A., Javed, A., Mayes, D. G., von Büdingen, H.-C., Klingelschmitt, G., et al. (2022) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000200071 · Cited by 68
“Detailed methodology for the SAkuraSky and SAkuraStar studies has been reported previously.(13,14)”
BackgroundMethodResultInfluentialSelf-citationEvolution of Anti-B Cell Therapeutics in Autoimmune Neurological Diseases
Stathopoulos, P., & Dalakas, M. C. (2022) · Neurotherapeutics · doi:10.1007/s13311-022-01196-w · Cited by 68
Cree, B., Kim, H. J., Weinshenker, B. G., Pittock, S. J., Wingerchuk, D. M., Fujihara, K., Paul, F., Cutter, G., Marignier, R., Green, A., et al. (2024) · The Lancet Neurology · doi:10.1016/s1474-4422(24)00077-2 · Cited by 65
Self-citationMa, X., Kermode, A. G., Hu, X., & Qiu, W. (2020) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2020.102522 · Cited by 63
Yamamura, T., Weinshenker, B. G., Yeaman, M. R., Seze, J. D., Patti, F., Lobo, P., von Büdingen, H.-C., Kou, X., Weber, K., & Greenberg, B. M. (2022) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2022.104025 · Cited by 63
Self-citationAdvances and challenges in the treatment of myasthenia gravis
Schneider‐Gold, C., & Gilhus, N. E. (2021) · Therapeutic Advances in Neurological Disorders · doi:10.1177/17562864211065406 · Cited by 62
Monoclonal Antibodies as Neurological Therapeutics
Gklinos, P., Papadopoulou, M., Stanulović, V., Mitsikostas, D. D., & Papadopoulos, D. (2021) · Pharmaceuticals · doi:10.3390/ph14020092 · Cited by 65
Antibody Therapies in Autoimmune Encephalitis
Smets, I., & Titulaer, M. J. (2022) · Neurotherapeutics · doi:10.1007/s13311-021-01178-4 · Cited by 61
Treatment of Neuromyelitis Optica Spectrum Disorders
Chan, K., & Lee, C. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22168638 · Cited by 67
Therapies in Stiff-Person Syndrome
Dalakas, M. C. (2023) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000200109 · Cited by 59
“Anti–interleukin-6-receptor antagonists, such as tocilizumab and also satralizumab, humanized monoclonal antibodies that bind both the soluble and the membrane-bound interleukin-6 receptor, which plays a role in B cell activation and T cell differentiation, and have been already approved for NMO-SD and show promise in…”
BackgroundGospe, S. M., Chen, J. J.-W., & Bhatti, M. T. (2020) · Eye · doi:10.1038/s41433-020-01334-8 · Cited by 60
Novel Immunotherapies for Myasthenia Gravis
Nair, S. S., & Jacob, S. (2023) · ImmunoTargets and Therapy · doi:10.2147/itt.s377056 · Cited by 62
Double-negative neuromyelitis optica spectrum disorder
Wu, Y. T., Geraldes, R., Juryńczyk, M., & Palace, J. A. (2023) · Multiple Sclerosis Journal · doi:10.1177/13524585231199819 · Cited by 57
“55,56 The role of IL-6 in DN NMO/NMOSD is thus unclear as it has been reported to be increased in the CSF of some DN patients although less than in those with AQP4 antibodies.”
Myasthenia gravis in 2025: five new things and four hopes for the future
Binks, S. N. M., Morse, I. M., Ashraghi, M. R., Vincent, A. C., Waters, P. J., & Leite, M. I. (2025) · Journal of Neurology · doi:10.1007/s00415-025-12922-7 · Cited by 59
Tofacitinib treatment for refractory autoimmune encephalitis
Jang, Y., Lee, W., Lee, H. S., Chu, K., Lee, S. K., & Lee, S. (2021) · Epilepsia · doi:10.1111/epi.16848 · Cited by 55
Interleukin-6 in Traumatic Brain Injury: A Janus-Faced Player in Damage and Repair
Ciryam, P., Gerzanich, V., & Simard, J. M. (2023) · Journal of Neurotrauma · doi:10.1089/neu.2023.0135 · Cited by 55
Recent progress in maintenance treatment of neuromyelitis optica spectrum disorder
Holmøy, T., Høglund, R. A., Illés, Z., Myhr, K., & Torkildsen, Ø. (2020) · Journal of Neurology · doi:10.1007/s00415-020-10235-5 · Cited by 55
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
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 56
“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
“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
“SAkuraStar Trial Design This was an international, randomized, double-blind, placebo-controlled, phase 3 trial [140].”
MethodShi, M., Chu, F., Jin, T., & Zhu, J. (2022) · CNS Neuroscience & Therapeutics · doi:10.1111/cns.13836 · Cited by 50
Cytokine dynamics and targeted immunotherapies in autoimmune encephalitis
Ciano-Petersen, N. L., Muñiz‐Castrillo, S., Birzu, C., Vogrig, A., Farina, A., Villagrán‐García, M., Joubert, B., Psimaras, D., & Honnorat, J. (2022) · Brain Communications · doi:10.1093/braincomms/fcac196 · Cited by 50
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
Tur, C., Dubessy, A., Otero‐Romero, S., Amato, M. P., Derfuss, T., Pauli, F. D., Iacobaeus, E., Mycko, M. P., Abboud, H., Achiron, A., et al. (2022) · Multiple Sclerosis Journal · doi:10.1177/13524585211069068 · Cited by 50
“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
Neuromyelitis optica spectrum disorder in China: Quality of life and medical care experience
Huang, W., ZhangBao, J., Chang, X., Wang, L., Zhao, C., Lu, J., Wang, M., Ding, X., Xu, Y., Zhou, L., et al. (2020) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2020.102542 · Cited by 47
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 50
“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
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 48
“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
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 43
Kraker, J. A., & Chen, J. J.-W. (2023) · Journal of Neurology · doi:10.1007/s00415-023-11920-x · Cited by 47
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
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
“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
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
“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
“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
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 45
“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
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
Wingerchuk, D. M., Zhang, I., Kielhorn, A., Royston, M., Levy, M., Fujihara, K., Nakashima, I., Tanvir, I., Paul, F., & Pittock, S. J. (2021) · Neurology and Therapy · doi:10.1007/s40120-021-00295-8 · Cited by 40
“(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
“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
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
“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
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 33
“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
“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.”
Velasco, M., Zarco, L. A., Agudelo-Arrieta, M., Torres-Camacho, I., Garcia-Cifuentes, E. R., & Múñoz, Ó. (2021) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2021.102869 · Cited by 31
Solomon, J. M., Paul, F., Chien, C., Oh, J., & Rotstein, D. (2021) · Therapeutic Advances in Neurological Disorders · doi:10.1177/17562864211014389 · Cited by 32
Neuromyelitis Optica Spectrum Disorder With Anti-Aquaporin-4 Antibody: Outcome Prediction Models
Wang, L., Du, L., Li, Q., Li, F., Wang, B., Zhao, Y., Meng, Q., Li, W., Pan, J., Xia, J., et al. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.873576 · Cited by 31
Berthele, A., Levy, M., Wingerchuk, D. M., Pittock, S. J., Shang, S., Kielhorn, A., Royston, M., Sabatella, G., & Palace, J. A. (2023) · Frontiers in Neurology · doi:10.3389/fneur.2023.1099376 · Cited by 30
Drug Treatment of Neuromyelitis Optica Spectrum Disorders: Out with the Old, in with the New?
Held, F., Klein, A.-K., & Berthele, A. (2021) · ImmunoTargets and Therapy · doi:10.2147/itt.s287652 · Cited by 30
Tahara, M., Oeda, T., Okada, K., Ochi, K., Maruyama, H., Fukaura, H., Nomura, K., Shimizu, Y., Nakashima, I., Misu, T., et al. (2022) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2022.103730 · Cited by 29
SARS-CoV-2 and Multiple Sclerosis: Potential for Disease Exacerbation
MacDougall, M., Sleiman, J. E.-H., Beauchemin, P., & Rangachari, M. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.871276 · Cited by 30
Structural insights into IL-6 signaling inhibition by therapeutic antibodies
Wang, M., Chen, L., He, J., Xia, W., Ye, Z., & She, J. (2024) · Cell Reports · doi:10.1016/j.celrep.2024.113819 · Cited by 28
Interleukin-6: evolving role in the management of neuropathic pain in neuroimmunological disorders
Serizawa, K., Tomizawa-Shinohara, H., Miyake, S., Yogo, K., & Matsumoto, Y. (2021) · Inflammation and Regeneration · doi:10.1186/s41232-021-00184-5 · Cited by 28
“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
Bauer, A., Rudzki, D., Berek, K., Dinoto, A., Lechner, C., Wendel, E., Hegen, H., Deisenhammer, F., Berger, T., Höftberger, R., et al. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.1037812 · Cited by 28
Current perspectives on the diagnosis and management of acute transverse myelitis
Tisavipat, N., & Flanagan, E. P. (2023) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2023.2195095 · Cited by 27
“efficacy of satralizumab as a monotherapy [193,194].”
Sechi, E. (2024) · CONTINUUM Lifelong Learning in Neurology · doi:10.1212/con.0000000000001454 · Cited by 30
Remlinger, J., Madarasz, A., Guse, K., Hoepner, R., Bagnoud, M., Meli, I., Feil, M., Abegg, M. H., Linington, C., Shock, A., et al. (2022) · Neurology Neuroimmunology & Neuroinflammation · doi:10.1212/nxi.0000000000001134 · Cited by 27
Treatment and Relapse Prevention of Typical and Atypical Optic Neuritis
Saitakis, G., & Chwalisz, B. K. (2022) · International Journal of Molecular Sciences · doi:10.3390/ijms23179769 · Cited by 27
“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].”
BackgroundMethodLeite, M. I., Panahloo, Z., Harrison, N., & Palace, J. A. (2023) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2023.104760 · Cited by 28
Nakashima, I., Nakahara, J., Yasunaga, H., Yamashita, M., Nishijima, N., Satomura, A., Nio, M., & Fujihara, K. (2024) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2024.105502 · Cited by 26
Abboud, H., Zheng, C. Y., Kar, I., Chen, C. K., Sau, C., & Serra, A. (2020) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2020.102249 · Cited by 25
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
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
