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Eculizumab monotherapy for NMOSD: Data from PREVENT and its open-label extension

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 o...

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Detalles Bibliográficos
Autores principales: Pittock, Sean J, Fujihara, Kazuo, Palace, Jacqueline, Berthele, Achim, Kim, Ho Jin, Oreja-Guevara, Celia, Nakashima, Ichiro, Levy, Michael, Shang, Shulian, Yountz, Marcus, Miller, Larisa, Armstrong, Róisín, Wingerchuk, Dean M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8894682/
https://www.ncbi.nlm.nih.gov/pubmed/34498507
http://dx.doi.org/10.1177/13524585211038291
Descripción
Sumario: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.