期刊
NEUROLOGY-CLINICAL PRACTICE
卷 6, 期 2, 页码 102-115出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/CPJ.0000000000000227
关键词
-
资金
- NHMRC [628856, 1071124, 1032484, 1083539]
- NHMRC Center for Research Excellence [1001216]
- MSBase Foundation
- Merck Serono
- Biogen
- Novartis Pharma
- Bayer-Schering
- Sanofi-Aventis
- BioCSL
- Czech Ministry of Education [PRVOUK-P26/LF1/4]
- National Health and Medical Research Council of Australia [1071124, 1083539] Funding Source: NHMRC
Background: We compared efficacy and treatment persistence in treatment-naive patients with relapsing-remitting multiple sclerosis (RRMS) initiating natalizumab compared with interferon-beta (IFN-beta)/glatiramer acetate (GA) therapies, using propensity score-matched cohorts from observational multiple sclerosis registries. Methods: The study population initiated IFN-beta/GA in the MSBase Registry or natalizumab in the Tysabri Observational Program, had >= 3 months of on-treatment follow-up, and had active RRMS, defined as >= 1 gadolinium-enhancing lesion on cerebral MRI at baseline or >= 1 relapse within the 12 months prior to baseline. Baseline demographics and disease characteristics were balanced between propensity-matched groups. Annualized relapse rate (ARR), time to first relapse, treatment persistence, and disability outcomes were compared between matched treatment arms in the total population (n = 366/group) and subgroups with higher baseline disease activity. Results: First-line natalizumab was associated with a 68% relative reduction in ARR from a mean (SD) of 0.63 (0.92) on IFN-beta/GA to 0.20 (0.63) (p [signed-rank] < 0.0001), a 64% reduction in the rate of first relapse (hazard ratio [HR] 0.36, 95% confidence interval [CI] 0.28-0.47; p < 0.001), and a 27% reduction in the rate of discontinuation (HR 0.73, 95% CI 0.58-0.93; p = 0.01), compared with first-line IFN-beta/GA therapy. Confirmed disability progression and area under the Expanded Disability Status Scale-time curve analyses were not significant. Similar relapse and treatment persistence results were observed in each of the higher disease activity subgroups. Conclusions: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse and treatment persistence outcomes compared to first-line IFN-beta/GA. This needs to be balanced against the risk of progressive multifocal leukoencephalopathy in natalizumab-treated patients. Classification of evidence: This study provides Class IV evidence that first-line natalizumab for RRMS improves relapse rates and treatment persistence outcomes compared to first-line IFN-beta/GA.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据