Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Division of Pharmaceutical Outcomes and Policy, University of North Carolina School of Pharmacy, Chapel Hill, North Carolina, USA.
Pharmacoepidemiol Drug Saf. 2022 Apr;31(4):481-487. doi: 10.1002/pds.5411. Epub 2022 Feb 7.
Multiple sclerosis (MS) is a chronic disease of the central nervous system that disproportionately affects women, with typical onset during reproductive age. Several disease-modifying therapies (DMTs) are FDA-approved to slow disease progression, but are not indicated for use during pregnancy. Our objective was to describe trends over time (2010-2019) in monthly point prevalence of DMT use among reproductive-age women, overall and by generic name.
This study used administrative claims data from the US during 2009-2019 to identify women age 15-44 with MS and continuous insurance coverage for ≥12 months. DMTs were identified using prescription fills and procedural claims for alemtuzumab, daclizumab, dimethyl fumarate, fingolimod, glatiramer acetate, interferon beta, mitoxantrone, natalizumab, ocrelizumab, and teriflunomide. Monthly prevalent use was defined as ≥1 days' supply of a DMT in the month. Age- and region-standardized monthly prevalence was estimated nonparametrically.
Among 42 281 reproductive-aged women over 818 179 person-months, DMT use increased from a minimum monthly prevalence of 49.3% (February, 2011) to a maximum of 58.7% (April, 2019). In 2010, prevalence of injectable DMTs was 43.1% compared to 2.5% for oral DMTs; by 2014, however, oral DMTs (26.5%) surpassed injectable DMTs (23.7%) as the most common route of administration. In the most recent data available (December, 2019), the most common DMTs were dimethyl fumarate, glatiramer acetate, and fingolimod.
DMT use among reproductive-aged women has rapidly evolved during the past decade. Collaborative treatment decision making between women with MS and clinicians may help optimize MS care and improve DMT uptake during reproductive years.
多发性硬化症(MS)是一种中枢神经系统的慢性疾病,女性发病率不成比例,发病典型时期为生育年龄。有几种疾病修正疗法(DMT)获得了美国食品和药物管理局(FDA)的批准,可减缓疾病进展,但不建议在怀孕期间使用。我们的目的是描述(2010-2019 年)生育年龄女性使用 DMT 的月度时点患病率随时间的变化趋势,总体趋势和按通用名的趋势。
本研究使用了美国 2009-2019 年期间的行政索赔数据,以确定年龄在 15-44 岁之间、有连续医疗保险覆盖≥12 个月的 MS 女性。使用处方配药和程序性索赔数据来识别阿仑单抗、达利珠单抗、二甲基富马酸、芬戈莫德、那他珠单抗、干扰素β、米托蒽醌、奥瑞珠单抗和特立氟胺等 DMT。每月的流行使用定义为当月 DMT 至少有 1 天的供应量。以年龄和地区为基准的每月患病率采用非参数法进行估计。
在 42281 名生育年龄的女性中,有 818179 人月,DMT 的使用从 2011 年 2 月的最低月度流行率 49.3%(2011 年 2 月)增加到 2019 年 4 月的最高流行率 58.7%。2010 年,注射用 DMT 的患病率为 43.1%,而口服 DMT 的患病率为 2.5%;然而,到 2014 年,口服 DMT(26.5%)超过了注射用 DMT(23.7%),成为最常见的给药途径。在最新可用的数据(2019 年 12 月)中,最常见的 DMT 是二甲基富马酸、聚乙二醇干扰素β-1a 和芬戈莫德。
在过去十年中,生育年龄女性使用 DMT 的情况迅速发展。MS 女性和临床医生之间的协作治疗决策可能有助于优化 MS 护理,并在生育期间提高 DMT 的使用率。