The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.
Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial
Abstract
Background No approved therapies exist for neuromyelitis optica spectrum disorder (NMOSD), a rare, relapsing, autoimmune, inflammatory disease of the CNS that causes blindness and paralysis. We aimed to assess the efficacy and safety of inebilizumab, an anti-CD19, B cell-depleting antibody, in reducing the risk of attacks and disability in NMOSD. Methods We did a multicentre, double-blind, randomised placebo-controlled phase 2/3 study at 99 outpatient specialty clinics or hospitals in 25 countries. Eligible participants were adults (≥18 years old) with a diagnosis of NMOSD, an Expanded Disability Status Scale score of 8·0 or less, and a history of at least one attack requiring rescue therapy in the year before screening or at least two attacks requiring rescue therapy in the 2 years before screening. Participants were randomly allocated (3:1) to 300 mg intravenous inebilizumab or placebo with a central interactive voice response system or interactive web response system and permuted block randomisation. Inebilizumab or placebo was administered on days 1 and 15. Participants, investigators, and all clinical staff were masked to the treatments, and inebilizumab and placebo were indistinguishable in appearance. The primary endpoint was time to onset of an NMOSD attack, as determined by the adjudication committee. Efficacy endpoints were assessed in all randomly allocated patients who received at least one dose of study intervention, and safety endpoints were assessed in the as-treated population. The study is registered with ClinicalTrials.gov, number NCT02200770. Findings Between Jan 6, 2015, and Sept 24, 2018, 230 participants were randomly assigned to treatment and dosed, with 174 participants receiving inebilizumab and 56 receiving placebo. The randomised controlled period was stopped before complete enrolment, as recommended by the independent data-monitoring committee, because of a clear demonstration of efficacy. 21 (12%) of 174 participants receiving inebilizumab had an attack versus 22 (39%) of 56 participants receiving placebo (hazard ratio 0·272 [95% CI 0·150-0·496]; p<0·0001). Adverse events occurred in 125 (72%) of 174 participants receiving inebilizumab and 41 (73%) of 56 participants receiving placebo. Serious adverse events occurred in eight (5%) of 174 participants receiving inebilizumab and five (9%) of 56 participants receiving placebo. Interpretation Compared with placebo, inebilizumab reduced the risk of an NMOSD attack. Inebilizumab has potential application as an evidence-based treatment for patients with NMOSD. Funding MedImmune and Viela Bio.
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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 [68]
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Revised diagnostic criteria for neuromyelitis optica
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Hauser, S. L., Bar-Or, A., Comi, G., Giovannoni, G., Hartung, H.-P., Hemmer, B., Lublin, F., Montalban, X., Rammohan, K. W., Selmaj, K., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1601277 · Cited by 2,021
Self-citationOcrelizumab versus Placebo in Primary Progressive Multiple Sclerosis
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Self-citationEculizumab 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
Self-citationAn open label study of the effects of rituximab in neuromyelitis optica
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Self-citationNeuromyelitis Optica Study Group (NEMOS), Trebst, C., Jarius, S., Berthele, A., Paul, F., Schippling, S., Wildemann, B., Borisow, N., Kleiter, I., Aktas, O., et al. (2014) · Journal of Neurology · doi:10.1007/s00415-013-7169-7 · Cited by 595
Self-citationIntrathecal pathogenic anti–aquaporin‐4 antibodies in early neuromyelitis optica
Bennett, J. L., Lam, C., Kalluri, S. R., Saikali, P., Bautista, K., Dupree, C., Glogowska, M. J., Case, D., Antel, J. P., Owens, G. P., et al. (2009) · Annals of Neurology · doi:10.1002/ana.21802 · Cited by 593
Self-citationNeuromyelitis optica IgG predicts relapse after longitudinally extensive transverse myelitis
Weinshenker, B. G., Wingerchuk, D. M., Vukusic, S., Linbo, L., Pittock, S. J., Lucchinetti, C. F., & Lennon, V. A. (2006) · Annals of Neurology · doi:10.1002/ana.20770 · Cited by 585
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“However, current therapies, including broad immunosuppression 35 and new monoclonal antibodies 36 – 39 , do not speci fi cally target astrocytes, which are the speci fi c cell type affected by the pathogenic AQP4-IgG antibody in NMOSD pathogenesis 13 .”
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“…affinity-optimized, glycoengineered monoclonal antibody targeting cluster of differentiation 19 + (CD19 + ) B cells [6]—in NMOSD were assessed in the randomized, placebo-controlled N-MOmentum trial that led to regulatory approval of INEB in aquaporin- 4-seropositive (AQP4 + ) NMOSD [6, 7].”
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“…advances in NMOSD include biologic agents targeting B-cell activity, IL-6 signaling, and complement activation, such as Inebilizumab (anti-CD19) [ 23 ] , Satralizumab (anti-IL-6 receptor) [ 24 ] , and Eculizumab (anti-complement) [ 25 ] , offering new treatment possibilities and markedly…”
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“Inebilizumab, the first humanized anti-CD19 monoclonal antibody approved globally for NMOSD, exerts its therapeutic effect by selectively depleting CD19 ⁺ B cells and plasmablasts, thereby blocking the generation of pathogenic AQP4 antibodies [6].”
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“B-cell depleting agents represented by rituximab and inebili-zumab can target and eliminate pathogenic B cells and inhibit AQP4-IgG production, which have become first-line core therapies for AQP4- IgG-positive NMOSD with expanding clinical application [8, 9, 11, 15–17].”
Metadata
- Authors
- 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., Green, A. J., Aktas, O., Hartung, H.-P., Lublin, F. D., Drappa, J., Barron, G., Madani, S., Ratchford, J. N., She, D., Cimbora, D., & Katz, E.
- Affiliations
- University of California, San Francisco (US)
- University of Colorado Anschutz (US)
- National Cancer Center (KR)
- Mayo Clinic (US)
- Mayo Clinic in Arizona (US)
- Fukushima Medical University (JP)
- Max Delbrück Center (DE)
- University of Alabama at Birmingham (US)
- Hospices Civils de Lyon (FR)
- Heinrich Heine University Düsseldorf (DE)
- Icahn School of Medicine at Mount Sinai (US)
- Corresponding author
- Cree, Bruce A C
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2019-10
- Volume
- 394
- Issue
- 10206
- Pages
- 1352-1363
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2972221943
- Cited by
- 756
- References
- 26
- Citations by year
- 2026: 105 · 2025: 118 · 2024: 102 · 2023: 101 · 2022: 102 · 2021: 117 · 2020: 101 · 2019: 7
- FWCI
- 58.77
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- MDC Repository (Max-Delbrueck-Center for Molecular Medicine) (submittedVersion)
- Funders
- Hospices Civils de Lyon
- Topics
- Health Sciences › Medicine › Clinical Neurology › Multiple Sclerosis Research Studies
- Health Sciences › Medicine › Clinical Neurology › Peripheral Neuropathies and Disorders
- Health Sciences › Medicine › Ophthalmology › Ocular Diseases and Behçet’s Syndrome
- Keywords
- neuromyelitis optica spectrum disorder, inebilizumab, anti-CD19, B-cell depletion, relapse prevention, disability progression, Expanded Disability Status Scale, treatment-emergent adverse events, autoimmune CNS disease, treatment efficacy and safety, relapse-free survival
- MeSH terms
- Adolescent, Adult, Aged, Double-Blind Method, Female, Hospitalization, Humans, Male, Middle Aged, Neuromyelitis Optica, Prospective Studies, Severity of Illness Index, Treatment Outcome, Young Adult, Antibodies, Monoclonal, Humanized
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