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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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Self-citationEculizumab in Aquaporin-4–Positive Neuromyelitis Optica Spectrum Disorder
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“Inebilizumab, a humanized monoclonal antibody that targets CD19-expressing B cells, plasma cells, and plasmablasts, has also been reported in a recent trial (NMomentum trial) to be beneficial in NMOSD.(84) The trial was stopped early after an interim analysis determined efficacy as defined by fewer attacks.”
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“There are only three treatments for NMOSD approved by the FDA, but only for adult patients with AQP4-IgG+, including a terminal complement protein (C5) inhibitor Soliris (eculizumab) injection in 2019 [438], an afucosylated IgG1 kappa monoclonal antibody Uplizna (inebilizumab-cdon) injection targeting CD19 [439], and…”
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“[13] The most common adverse events were infection and infusion‑related reactions (grade 1–2).”
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“The currently approved immunotherapies include eculizumab, ravuli-zumab, satralizumab, and inebilizumab [51–55].”
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“These results were particularly significant in the anti-AQP4-positive group (11% versus 42%; HR 0.227, 95% CI 0.121–0.423, p < 0.0001) [88].”
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A Clinical Approach to Existing and Emerging Therapeutics in Neuromyelitis Optica Spectrum Disorder
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What's new in neuromyelitis optica spectrum disorder treatment?
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“Inebilizumab was tested in the Phase II/III trial, N‐MOmentum,[81] that led to the approval of inebilizumab in the US and several other countries worldwide.”
BackgroundAn update on biologic treatments for neuromyelitis optica spectrum disorder
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“The N‑MOmentum study was a double‑blind, randomized, placebo‑controlled phase II/III clinical trial evaluating the efficacy of inebilizumab for the treatment of NMOSD (26).”
Therapeutic inertia in the management of neuromyelitis optica spectrum disorder
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“The pharmacodynamic effect of inebilizumab on B cells occurs within approximately 4 weeks, with a significant reduction in circulating B cells to less than 10% of baseline [16].”
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CD21lo B-cell subsets are recruited to the central nervous system in acute neuromyelitis optica
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“19,20 21-23 It is likely that DN-NMOSD can also be separated from its di ff erential diagnoses using distinct features.”
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“0001).(10) The objectives of this analysis were: (i) to develop a population pharmacodynamic (PD) model describing the depletion of the peripheral B-cell count by inebilizumab; and (ii) to evaluate the relationship between inebilizumab pharmacokinetic (PK) exposure and efficacy endpoints in subjects with NMOSD.”
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Current and emerging therapies for autoimmune encephalitis
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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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