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Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial
Open accessAbstract
Background Azathioprine is used as a first-line treatment to prevent relapses of neuromyelitis optica spectrum disorder (NMOSD). Tocilizumab has been reported to reduce NMOSD disease activity in retrospective case reports. We aimed to compare the safety and efficacy of tocilizumab and azathioprine in patients with highly relapsing NMOSD. Methods We did an open-label, multicentre, randomised, phase 2 trial at six hospitals in China. We recruited adult patients (aged ≥18 years) with highly relapsing NMOSD diagnosed according to 2015 International Panel for Neuromyelitis Optica Diagnosis criteria, who had an Expanded Disability Status Scale (EDSS) score of 7·5 or lower, and had a history of at least two clinical relapses during the previous 12 months or three relapses during the previous 24 months with at least one relapse within the previous 12 months. Patients were randomly assigned (1:1) to intravenous tocilizumab (8 mg/kg every 4 weeks) or oral azathioprine (2-3 mg/kg per day) by an independent statistician using computer-generated randomisation software with permuted blocks of four. The central review committee, EDSS raters, laboratory personnel, and radiologists were masked to the treatment assignment, but investigators and patients were aware of treatment allocation. The minimum planned duration of treatment was 60 weeks following randomisation. The primary outcome was time to first relapse in the full analysis set, which included all randomly assigned patients who received at least one dose of study drug, and the per-protocol population, which included all patients who used azathioprine or tocilizumab as monotherapy. For the analyses of the primary outcome, the patients were prespecified into two subgroups according to concomitant autoimmune disease status. Safety was assessed in the full analysis set. This study is registered with ClinicalTrials.gov, NCT03350633. Findings Between Nov 1, 2017, and Aug 3, 2018, we enrolled 118 patients, of whom 59 were randomly assigned to tocilizumab and 59 were randomly assigned to azathioprine. All 118 patients received one dose of study drug and were included in the full analysis set. 108 participants were included in the per-protocol analysis (56 in the tocilizumab group and 52 in the azathioprine group). In the full analysis set, median time to the first relapse was longer in the tocilizumab group than the azathioprine group (78·9 weeks [IQR 58·3-90·6] vs 56·7 [32·9-81·7] weeks; p=0·0026). Eight (14%) of 59 patients in the tocilizumab group and 28 (47%) of 59 patients in the azathioprine group had a relapse at the end of the study (hazard ratio [HR] 0·236 [95% CI 0·107-0·518]; p<0·0001). In the per-protocol analysis, 50 (89%) of 56 patients in the tocilizumab group were relapse-free compared with 29 (56%) of 52 patients in the azathioprine group at the end of the study (HR 0·188 [95% CI 0·076-0·463]; p<0·0001); the median time to first relapse was also longer in the tocilizumab group than the azathioprine group (67·2 weeks [IQR 47·9-77·9] vs 38·0 [23·6-64·9]; p<0·0001). In the prespecified subgroup analysis of the full analysis set stratified by concomitant autoimmune diseases, among patients without concomitant autoimmune diseases, three (9%) of 34 patients in the tocilizumab group and 13 (35%) of 37 patients in the azathioprine group had relapsed by the end of the study. Among patients with concomitant autoimmune diseases, a lower proportion of patients in the tocilizumab group had a relapse than in the azathioprine group (five [20%] of 25 patients vs 15 [68%] of 22 patients; HR 0·192 [95% CI 0·070-0·531]; p=0·0004). 57 (97%) of 59 patients in the tocilizumab group and 56 (95%) of 59 patients in the azathioprine group had adverse events. Treatment-associated adverse events occurred in 36 (61%) of 59 tocilizumab-treated patients and 49 (83%) of 59 azathioprine-treated patients. One death (2%) occurred in the tocilizumab group and one (2%) in the azathioprine group, but neither of the deaths were treatment-related. Interpretation Tocilizumab significantly reduced the risk of a subsequent NMOSD relapse compared with azathioprine. Tocilizumab might therefore be another safe and effective treatment to prevent relapses in patients with NMOSD. Funding Tianjin Medical University, Advanced Innovation Center for Human Brain Protection, National Key Research and Development Program of China, National Science Foundation of China.
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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”
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BackgroundA Pilot Study on Tocilizumab in Very-Late-Onset Myasthenia Gravis
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“Monoclonal antibody therapy targeting the IL-6-R has been shown to be effective in the treatment of NMOSD [23, 24], potentially by inducing regulatory B cells [25].”
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Self-citationWhat's new in neuromyelitis optica spectrum disorder treatment?
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“[79] Eculizumab was then the first one entering a pivotal phase III trial in NMOSD.”
MethodInfluentialAn update on biologic treatments for neuromyelitis optica spectrum disorder
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Advances in the therapeutic landscape for neuromyelitis optica spectrum disorder
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“These preliminary data supported a Phase 2 head-to-head study comparing tocilizumab (TCZ) and azathioprine (AZA) [38] in patients with highly active NMOSD (AQP4-IgG positive 85% and 90% respectively) with ≥1 relapse in the previous 12 months.”
Wang, Y., Zhao, M., Yao, M., Yang, Z., Li, B., Yin, L., & Geng, X. (2023) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2023.105062 · Cited by 6
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“Tocilizumab has been a subject of controversy in the context of MS. 1–7 Some case reports have suggested its possible role in either triggering or ameliorating MS. 2–6, 8 There has been mention of outbreaks of demyelinating neuroinflammatory diseases, especially MS, in some cases, but there”
RNA immunotherapy: revolutionizing cancer and autoimmune disease treatments
Savguira, M., Chen, D., Dong, S., & Li, B. (2025) · Trends in Molecular Medicine · doi:10.1016/j.molmed.2025.06.008 · Cited by 10
Ponleitner, M., & Rommer, P. S. (2022) · Wiener Medizinische Wochenschrift · doi:10.1007/s10354-022-00987-2 · Cited by 7
Neuromyelitis Optica Spectrum Disorders
Li, X., & McKeon, A. B. (2023) · Elsevier eBooks · doi:10.1016/b978-0-323-95702-1.00024-5 · Cited by 6
Frontiers and future perspectives of neuroimmunology
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Mitoxantrone in NMO Spectrum Disorder in a Large Multicenter Cohort in French Caribbean
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Can rheumatologists stop causing demyelinating disease?
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Прахова, Л. Н., Сергеевич, К. В., Kasatkin, D. S., & Korobko, D. S. (2022) · S S Korsakov Journal of Neurology and Psychiatry · doi:10.17116/jnevro202212207268 · Cited by 4
Measuring the economic burden of neuromyelitis optica spectrum disorder in Colombia
Gil-Rojas, Y., Amaya-Granados, D., Quiñones, J. A., Robles, A., Samacá-Samacá, D., & Hernández, F. (2023) · Multiple Sclerosis and Related Disorders · doi:10.1016/j.msard.2023.105376 · Cited by 4
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Mantero, V., Rigamonti, A., Basilico, P., Crespi, M., Balgera, R., & Salmaggi, A. (2020) · Journal of Neurology · doi:10.1007/s00415-020-10039-7 · Cited by 4
Recent advances in the treatment of neuromyelitis optica spectrum disorders
Romeo, A. R. (2021) · Current Opinion in Rheumatology · doi:10.1097/bor.0000000000000791 · Cited by 4
Du, Y., Li, K., Liu, W., Song, R., Luo, M., He, J., Xu, X., & Qu, X. (2021) · Current Pharmaceutical Design · doi:10.2174/1381612827666210329101335 · Cited by 4
Update on glial antibody-mediated optic neuritis
Song, H., Zhou, H., & Wei, S. (2022) · Japanese Journal of Ophthalmology · doi:10.1007/s10384-022-00932-1 · Cited by 4
Las audiencias y la administración de justicia en las Indias
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Neuromyelitis optic spectrum disorders (NMOSD): from pathogenesis to targeted therapy
Zaitseva, P. A., & Boyko, A. N. (2023) · Neurology neuropsychiatry Psychosomatics · doi:10.14412/2074-2711-2023-1s-49-57 · Cited by 5
Autoantibody-mediated central nervous system channelopathies
Binks, S. N. M., & Irani, S. R. (2024) · Handbook of clinical neurology · doi:10.1016/b978-0-323-90820-7.00005-7 · Cited by 3
Therapie antikörpervermittelter Enzephalomyelitiden
Ayzenberg, I., & Kleiter, I. (2021) · Der Nervenarzt · doi:10.1007/s00115-021-01090-4 · Cited by 3
Inflammatory Demyelinating Diseases of the Central Nervous System
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Dysregulated Tfh/B cells and their interactions in neuromyelitis optica spectrum disorder
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CAR T cell therapy in autoantibody-mediated neurological disorders: a promising strategy
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“In this context, it is important to acknowledge the considerably more mature clinical development of several monoclonal antibody therapies that have already achieved regulatory approval and demonstrated robust efficacy in NMOSD [11, 84–86].”
Neurologic autoimmune diseases
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Targeting IL-6 Signaling Pathways for Musculoskeletal Disorders Treatment: Risks and Benefits
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Randomized Controlled Trials for Neuromyelitis Optica Spectrum Disorder
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Neuromyelitis Optica Spectrum Disorder: An Early Diagnosis to Prevent Blindness and Paraplegia
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Metadata
- Authors
- Zhang, C., Zhang, M., Qiu, W., Ma, H., Zhang, X., Zhu, Z., Yang, C.-S., Jia, D., Zhang, T.-X., Yuan, M., Feng, Y., Yang, L., Lu, W., Yu, C., Bennett, J. L., & Shi, F.-D.
- Affiliations
- Capital Medical University (CN)
- Shanxi Medical University (CN)
- Sun Yat-sen University (CN)
- Tianjin Huanhu Hospital (CN)
- Tianjin Medical University General Hospital (CN)
- Tianjin Medical University (CN)
- University of Colorado Anschutz (US)
- Corresponding author
- Shi, Fu-Dong
- ORCID
- Venue
- The Lancet Neurology
- Publisher
- Elsevier BV
- Published
- 2020-05
- Volume
- 19
- Issue
- 5
- Pages
- 391-401
- ISSN
- 1474-4422 (ISSN-L)
- PMC
- PMC7935423
- OpenAlex
- W3019956952
- Cited by
- 287
- References
- 27
- Citations by year
- 2026: 34 · 2025: 31 · 2024: 37 · 2023: 49 · 2022: 54 · 2021: 53 · 2020: 26
- FWCI
- 29.30
- Type
- journal article
- Language
- en
- Update notices
- erratum (2025-12-01)
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- Locations
- The Lancet Neurology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Guthy-Jackson Charitable Foundation
- AbbVie
- Roche
- Topics
- Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Clinical Neurology › Peripheral Neuropathies and Disorders
- Health Sciences › Medicine › Ophthalmology › Drug-Induced Ocular Toxicity
- Keywords
- neuromyelitis optica spectrum disorder, tocilizumab, azathioprine, relapse prevention, time to first relapse, IL-6 inhibition, immunosuppressive therapy, concomitant autoimmune disease, treatment safety, Expanded Disability Status Scale, disease-modifying therapy, China
- MeSH terms
- Adult, Azathioprine, Female, Humans, Immunosuppressive Agents, Male, Middle Aged, Neuromyelitis Optica, Treatment Outcome, Antibodies, Monoclonal, Humanized
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