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- Title
(DXT52) Efficacy and Safety of Eculizumab in Patients with Neuromyelitis Optica Spectrum Disorder Previously Treated with Rituximab: The Phase 3 PREVENT Study.
- Authors
Levy, Michael; Berthele, Achim; Ho Jin Kim; Kazuo Fujihara; Ichiro Nakashima; Oreja-Guevara, Celia; Palace, Jacqueline; Pittock, Sean J.; Terzi, Murat; Totolyan, Natalia; Viswanathan, Shanthi; Kai-Chen Wang; Pace, Amy; Yountz, Marcus; Lawson, Diane; Laudon-Meyer, Eva; Wingerchuk, Dean
- Abstract
Background: In the PREVENT study, eculizumab was associated with a significant reduction in relapse risk vs placebo and was well tolerated. In total, 46 patients (26/96 receiving eculizumab, 20/47 receiving placebo) had been previously treated with the monoclonal antibody rituximab. Objectives: To describe the efficacy and safety of eculizumab in patients in the randomized, double-blind, placebo-controlled, phase 3 PREVENT trial (trial registration: NCT01892345) who had previously received rituximab. Methods: Adults with aquaporin-4 immunoglobulin G--positive neuromyelitis optica spectrum disorder (NMOSD) received eculizumab (maintenance dose, 1200 mg/2 weeks) or placebo with/without concomitant immunosuppressive treatment (except rituximab/mitoxantrone). A post hoc descriptive analysis was performed using data from patients with any prior rituximab treatment (within the previous year only for review of adverse events [AEs]) recorded more than 3 months before randomization. Results: Baseline characteristics of the prior-rituximab subgroup were similar to the total PREVENT population; however, the subgroup included a lower proportion of Asian patients (10.9% vs 36.4% in total PREVENT study population) and greater representation from the Americas (58.7% vs 30.8%). In the subgroup, median times from last dose of rituximab to meningococcal vaccination and to first dose of study treatment were 31.7 and 38.7 weeks, respectively. Adjudicated relapses occurred in 1/26 (3.8%) and 7/20 (35.0%) patients in the eculizumab and placebo arms, respectively (hazard ratio 0.093; 95% CI 0.011- 0.755; P = .0055). AE rates in patients receiving eculizumab and placebo within 1 year of previous rituximab use were 1025.8 and 1029.1 events/100 patient-years (both 100% of patients), respectively; rates of serious AEs were 46.9 and 66.0 events/100 patient-years (38.9% and 47.1% of patients), respectively. Serious infections/infestations were recorded in 2/18 (11.1%) and 2/17 (11.8%) patients in the eculizumab and placebo arms, respectively. Conclusions: In patients with aquaporin- 4 immunoglobulin G--positive NMOSD in PREVENT who had previously received rituximab, the risk of adjudicated relapse was significantly lower with eculizumab than with placebo. Rates of serious infections were similarly low with eculizumab and placebo.
- Subjects
THERAPEUTIC use of monoclonal antibodies; CONFERENCES &; conventions; RITUXIMAB; NEUROMYELITIS optica
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p34
- ISSN
1537-2073
- Publication type
Article