Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension.
Clinical trial
neuromyelitis optica (NMO)
Journal
Multiple sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
Titre abrégé: Mult Scler
Pays: England
ID NLM: 9509185
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
pubmed:
10
9
2021
medline:
17
3
2022
entrez:
9
9
2021
Statut:
ppublish
Résumé
During PREVENT (a phase 3, randomized, double-blind, placebo-controlled, time-to-event study) and its open-label extension (interim analysis), 33 adults with aquaporin-4 immunoglobulin G-positive neuromyelitis optica spectrum disorder (AQP4-IgG + NMOSD) received eculizumab monotherapy for a median of 2.8 years (range, 14 weeks-5.2 years). At 192 weeks (~4 years), 96% of these patients were free from adjudicated relapses (Kaplan-Meier analysis; 95% confidence interval, 75.7-99.4). During PREVENT, 95% (20/21) of patients receiving eculizumab monotherapy had no disability worsening. Eculizumab monotherapy provides effective long-term relapse prevention, relieving the chronic immunosuppression burden in patients with AQP4-IgG + NMOSD. ClinicalTrials.gov; PREVENT: NCT01892345; open-label extension: NCT02003144.
Identifiants
pubmed: 34498507
doi: 10.1177/13524585211038291
pmc: PMC8894682
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Aquaporin 4
0
Autoantibodies
0
Immunoglobulin G
0
eculizumab
A3ULP0F556
Banques de données
ClinicalTrials.gov
['NCT01892345', 'NCT02003144']
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
480-486Références
N Engl J Med. 2019 Aug 15;381(7):614-625
pubmed: 31050279
Drugs. 2020 May;80(7):719-727
pubmed: 32266705
Br J Haematol. 2013 Jul;162(1):62-73
pubmed: 23617322
Br J Haematol. 2019 Apr;185(2):297-310
pubmed: 30768680
Muscle Nerve. 2019 Jul;60(1):14-24
pubmed: 30767274
Kidney Int. 2015 May;87(5):1061-73
pubmed: 25651368
Lancet Neurol. 2007 Sep;6(9):805-15
pubmed: 17706564
Lancet. 2019 Oct 12;394(10206):1352-1363
pubmed: 31495497
Lancet Neurol. 2020 May;19(5):402-412
pubmed: 32333898