1 Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts.
4 Centre for Health Policy and Management, Trinity College, Dublin, Ireland.
J Manag Care Spec Pharm. 2019 Jan;25(1):113-121. doi: 10.18553/jmcp.2019.25.1.113.
The approval of new oral disease-modifying drugs (DMDs), such as fingolimod, dimethyl fumarate (DMF), and teriflunamide, has considerably expanded treatment options for relapsing forms of multiple sclerosis (MS). However, data describing the use of these agents in routine clinical practice are limited.
To describe time trends and identify factors associated with oral DMD treatment initiation and switching among individuals with MS.
Using data from a large sample of commercially insured patients, we evaluated changes over time in the proportion of MS patients who initiated treatment with an oral DMD and who switched from an injectable DMD to an oral DMD between 2009 and 2014 in the United States. We evaluated predictors of oral DMD use using conditional logistic regression in 2 groups matched on calendar time: oral DMD initiators matched to injectable DMDs initiators and oral DMD switchers matched to those who switched to a second injectable DMD.
Our cohort included 7,576 individuals who initiated a DMD and 1,342 who switched DMDs, of which oral DMDs accounted for 6% and 39%, respectively. Oral DMD initiation and switching steadily increased from 5% to 16% and 35% to 84%, respectively, between 2011 and 2014, with DMF being the most commonly used agent. Of the potential predictors with clinical significance, a recent neurologist consultation (OR = 1.60; 95% CI = 1.20-2.15) and emergency department visit (OR = 1.43; 95% CI = 1.01-2.01) were significantly associated with oral DMD initiation. History of depression was noted to be a potential predictor of oral DMD initiation; however, the estimate for this predictor did not reach statistical significance (OR = 1.35; 95% CI = 0.99-1.84). No clinically relevant factors measured in our data were associated with switching to an oral DMD.
Oral DMDs were found to be routinely used as second-line treatment. However, we identified few factors predictive of oral DMD initiation or switching, which implies that their selection is driven by patient and/or physician preferences.
This study was funded by CVS Caremark through an unrestricted research grant to Brigham and Women's Hospital. Shrank and Matlin were employees of, and shareholders in, CVS Health at the time of the study; they report no financial interests in products or services that are related to the subject of this study. Spettell is an employee of, and shareholder in, Aetna. Chitnis serves on clinical trial advisory boards for Novartis and Genzyme-Sanofi; has consulted for Bayer, Biogen Idec, Celgene, Novartis, Merck-Serono, and Genentech-Roche; and has received research support from NIH, National Multiple Sclerosis Society, Peabody Foundation, Consortium for MS Centers, Guthy Jackson Charitable Foundation, EMD-Serono, Novartis Biogen, and Verily. Desai reports receiving a research grant from Merck for unrelated work. Gagne is principal investigator of a research grant from Novartis Pharmaceuticals Corporation to the Brigham and Women's Hospital and has received grant support from Eli Lilly, all for unrelated work. He is also a consultant to Aetion and Optum. Minden reports grants from Biogen and other fees from Genentech, EMD Serano, Avanir, and Novartis, unrelated to this study. The other authors have no conflicts to report. This study was presented as a poster at the International Society for Pharmacoepidemiology 32nd Annual Meeting; August 25-28, 2016; Dublin, Ireland.
随着芬戈莫德、二甲基富马酸(DMF)和特立氟胺等新型口服疾病修正药物(DMD)的获批,复发型多发性硬化症(MS)的治疗选择大大增加。然而,有关这些药物在常规临床实践中使用的数据有限。
描述时间趋势,并确定与 MS 患者开始使用口服 DMD 药物和从注射用 DMD 转换为口服 DMD 相关的因素。
使用来自大型商业保险患者的数据,我们评估了 2009 年至 2014 年期间,美国 MS 患者中开始使用口服 DMD 药物的比例以及从注射用 DMD 转换为口服 DMD 的比例的变化。我们使用条件逻辑回归评估了口服 DMD 使用的预测因素,在两组中进行了匹配:口服 DMD 启动者与注射用 DMD 启动者匹配,口服 DMD 转换者与转换为第二种注射用 DMD 的患者匹配。
我们的队列包括 7576 名开始使用 DMD 的患者和 1342 名转换 DMD 的患者,其中口服 DMD 分别占 6%和 39%。2011 年至 2014 年期间,口服 DMD 的启动和转换率分别从 5%稳步增加到 16%和 35%增加到 84%,其中 DMF 是最常用的药物。在具有临床意义的潜在预测因素中,最近的神经科医生咨询(OR=1.60;95%CI=1.20-2.15)和急诊就诊(OR=1.43;95%CI=1.01-2.01)与口服 DMD 的启动显著相关。有抑郁病史被认为是口服 DMD 启动的潜在预测因素;然而,该预测因素的估计值未达到统计学意义(OR=1.35;95%CI=0.99-1.84)。我们数据中测量的没有其他临床相关因素与转换为口服 DMD 相关。
发现口服 DMD 被常规用作二线治疗。然而,我们确定了很少的因素可以预测口服 DMD 的启动或转换,这表明它们的选择是由患者和/或医生的偏好驱动的。
本研究由 CVS Caremark 通过对布里格姆妇女医院的一项不受限制的研究赠款资助。在研究期间,Shrank 和 Matlin 是 CVS Health 的员工和股东;他们在与本研究主题相关的产品或服务方面没有财务利益。Spettell 是 Aetna 的员工和股东。Chitnis 担任诺华和 Genzyme-Sanofi 的临床试验顾问委员会成员;曾为 Bayer、Biogen Idec、Celgene、诺华、默克-雪兰诺、Genentech-Roche 咨询;并从 NIH、国家多发性硬化症协会、皮博迪基金会、多发性硬化症中心联盟、Guthy Jackson 慈善基金会、EMD-Serono、诺华 Biogen 和 Verily 获得研究支持。Desai 报告因其他工作从默克获得研究资助。Gagne 是 Brigham and Women's Hospital 与诺华制药公司合作的研究资助的主要研究者,并且还为 Eli Lilly 等其他工作获得了资助,均与本研究无关。他还是 Aetion 和 Optum 的顾问。Minden 报告有 Biogen 的资助和其他来自 Genentech、EMD Serano、Avanir 和 Novartis 的费用,与本研究无关。其他作者没有利益冲突。这项研究作为海报在国际药物流行病学学会第 32 届年会上提出;2016 年 8 月 25-28 日;爱尔兰都柏林。