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Cited by 756Multiple Sclerosis Research StudiesPeripheral Neuropathies and DisordersOcular Diseases and Behçet’s Syndrome

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

Cree, Bruce A C, Bennett, Jeffrey L, Kim, Ho Jin, Weinshenker, Brian G, Pittock, Sean J, Wingerchuk, Dean M, Fujihara, Kazuo, Paul, Friedemann, Cutter, Gary R, Marignier, Romain, Green, Ari J, Aktas, Orhan, Hartung, Hans-Peter, Lublin, Fred D, Drappa, Jorn, Barron, Gerard, Madani, Soraya, Ratchford, John N, She, Dewei, Cimbora, Daniel, Katz, Eliezer·2019·The Lancet
DOI 10.1016/s0140-6736(19)31817-3
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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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Crossref · 10.1016/s0140-6736(19)31817-3

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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
DOI
10.1016/s0140-6736(19)31817-3
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
Licence
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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