Geisel School of Medicine at Dartmouth, Hanover, NH.
Novartis Pharmaceuticals Corporation, East Hanover, NJ.
J Manag Care Spec Pharm. 2021 Sep;27(9):1157-1170. doi: 10.18553/jmcp.2021.21060. Epub 2021 May 17.
Migraine is a common neurological disease that can have a substantial impact on patients' lives and on society. Erenumab, a fully human monoclonal antibody that targets the calcitonin gene-related peptide receptor, was specifically developed for migraine prevention. The efficacy of erenumab has been established in several clinical trials; however, the real-world comparative effectiveness of erenumab has not been fully investigated. To evaluate the real-world impact of erenumab and onabotulinumtoxinA on acute medication usage and health care resource utilization (HCRU) among patients with migraine in the United States. This retrospective US claims analysis (Optum's deidentified Clinformatics Data Mart Database) evaluated patients aged at least 18 years diagnosed with migraine who initiated erenumab or onabotulinumtoxinA between May 1, 2018, and September 30, 2019 (index date: first erenumab/onabotulinumtoxinA claim). Cohorts were matched 1:1 using the propensity score (PS) method (greedy match with caliper = 0.1). Stratification was performed based on gender, chronic migraine without aura diagnosis, onabotulinumtoxinA use, and acute/preventive drug use. The impact of erenumab and onabotulinumtoxinA on acute medication usage and HCRU was assessed in the 6-month post-index period. An exploratory analysis assessed the impact of erenumab and onabotulinumtoxinA on a composite endpoint of: (1) outpatient visit with a migraine diagnosis and associated acute medication claim, (2) hospital admission with a primary migraine diagnosis, or (3) emergency department visit with a primary migraine diagnosis. PS-matched data were used for comparative analyses; logistic regression with covariate adjustment was used for dichotomous variables, and a negative binomial model was used for count variables, with odds ratios or rate ratios (RRs) and 95% CIs calculated. Following stratified PS matching, 1,338 patients were included in both cohorts. At 6 months, the adjusted average number of claims per person for any acute medication was significantly lower in the erenumab cohort (1.13 vs 1.29 in the onabotulinumtoxinA cohort; RR = 0.88; 95% CI = 0.80-0.96; = 0.0069), although the difference in the number of claims for triptans and barbiturates was statistically nonsignificant. The adjusted average number of all-cause and migraine-specific visits per person to health care providers was generally lower in the erenumab cohort compared with the onabotulinumtoxinA cohort. Patients in the erenumab cohort had a significantly lower number of composite events (0.44 vs 0.69 in the onabotulinumtoxinA cohort; RR = 0.63; 95% CI = 0.56-0.71; < 0.0001). Similarly, the adjusted proportion of patients with any of the 3 composite events was lower in the erenumab cohort (31.7% vs 44.3% in the onabotulinumtoxinA cohort; OR = 0.59; 95% CI = 0.49-0.70; < 0.0001). In this retrospective claims analysis study, erenumab significantly reduced acute medication usage (opioids and nonsteroidal anti-inflammatory drugs; any acute medication when analyzed together) and HCRU to a greater extent than onabotulinumtoxinA. This study was supported by Novartis Pharma AG. Novartis employees contributed to the study design, analysis of the data, and the decision to publish the results. Fang, Abdrabboh, Glassberg, Vo, and Ferraris are employed by Novartis. Zhou and Shen are employed by KMK Consulting, Inc., which received funding from Novartis to conduct the study. Tepper reports grants from Allergan, Amgen, ElectroCore, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma, and Zosano, outside the submitted work; personal fees from Dartmouth-Hitchcock Medical Center, American Headache Society, Thomas Jefferson University, Aeon, Align Strategies, Allergan/AbbVie, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, CoolTech, CRG, Currax, Decision Resources, DeepBench, DRG, Eli Lilly, Equinox, ExpertConnect, GLG, Guidepoint Global Healthcare Consultancy Group, Health Science Communications, HMP Communications, Impel, InteractiveForums, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurorelief, Nordic BioTech, Novartis, Pulmatrix, Reckner Healthcare, Relevale, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Sudler and Hennessey, Synapse Medical Communications, System Analytic, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC, Zosano, Krog and Partners, and Lundbeck, outside the submitted work; and CME honoraria from American Academy of Neurology, American Headache Society, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital, Ontario, Canada, Headache Cooperative of New England, Henry Ford Hospital, Detroit, Inova, Medical Learning Institute PeerView, Medical Education Speakers Network, Miller Medical Communications, North American Center for CME, Physicians' Education Resource, Rockpointe, ScientiaCME, WebMD/Medscape. The abstract and poster of these results were presented at The Migraine Trust Virtual Symposium (MTIS), October 3-9, 2020.
偏头痛是一种常见的神经系统疾病,会对患者的生活和社会造成重大影响。依瑞奈单抗是一种针对降钙素基因相关肽受体的全人源单克隆抗体,专门用于预防偏头痛。几项临床试验已经证实了依瑞奈单抗的疗效;然而,依瑞奈单抗在真实世界中的比较有效性尚未得到充分研究。
本研究旨在评估依瑞奈单抗和肉毒毒素 A 型(onabotulinumtoxinA)对美国偏头痛患者急性药物使用和医疗资源利用(HCRU)的真实世界影响。
这是一项回顾性美国索赔分析(Optum 的匿名 Clinformatics Data Mart 数据库),评估了 2018 年 5 月 1 日至 2019 年 9 月 30 日期间至少 18 岁、被诊断为偏头痛且开始使用依瑞奈单抗或肉毒毒素 A 型的患者。采用倾向评分(PS)法(卡尺=0.1)进行 1:1 匹配。根据性别、无先兆偏头痛的慢性诊断、肉毒毒素 A 型的使用情况和急性/预防性药物使用情况进行分层。在索引后 6 个月评估依瑞奈单抗和肉毒毒素 A 型对急性药物使用和 HCRU 的影响。一项探索性分析评估了依瑞奈单抗和肉毒毒素 A 型对以下复合终点的影响:(1)偏头痛诊断相关的门诊就诊和相关急性药物就诊,(2)原发性偏头痛的住院治疗,或(3)原发性偏头痛的急诊就诊。采用 PS 匹配数据进行比较分析;二分类变量采用协变量调整的逻辑回归,计数变量采用负二项回归模型,计算比值比(OR)或率比(RR)及其 95%置信区间(CI)。
经过分层 PS 匹配,共有 1338 名患者纳入两个队列。在 6 个月时,依瑞奈单抗组的人均任何急性药物的平均就诊次数显著低于肉毒毒素 A 组(依瑞奈单抗组为 1.13,肉毒毒素 A 组为 1.29;RR=0.88;95%CI=0.80-0.96;P=0.0069),尽管曲普坦类药物和巴比妥类药物的就诊次数差异无统计学意义。与肉毒毒素 A 组相比,依瑞奈单抗组的人均就诊次数总体较低,包括所有原因和偏头痛特异性的医疗保健提供者就诊次数。依瑞奈单抗组的复合事件(0.44 次 vs 肉毒毒素 A 组的 0.69 次;RR=0.63;95%CI=0.56-0.71;P<0.0001)也明显较少。同样,依瑞奈单抗组中任何 3 项复合事件的患者比例也较低(31.7% vs 肉毒毒素 A 组的 44.3%;OR=0.59;95%CI=0.49-0.70;P<0.0001)。
在这项回顾性索赔分析研究中,与肉毒毒素 A 型相比,依瑞奈单抗显著减少了急性药物(阿片类药物和非甾体抗炎药;一起分析时为任何急性药物)的使用和 HCRU。
这项研究得到了诺华制药公司的支持。诺华制药公司的员工参与了研究设计、数据分析和决定发表研究结果。Fang、Abdrabboh、Glassberg、Vo 和 Ferraris 受雇于诺华制药公司。Zhou 和 Shen 受雇于 KMK 咨询公司,该公司从诺华制药公司获得资金开展这项研究。Tepper 报告说,他从 Allergan、Amgen、ElectroCore、Eli Lilly、Lundbeck、Neurolief、Novartis、Satsuma 和 Zosano 获得了拨款,在这项工作之外还报告了与 Dartmouth-Hitchcock Medical Center、American Headache Society、Thomas Jefferson University、Aeon、Align Strategies、Allergan/AbbVie、Alphasights、Amgen、Aperture Venture Partners、Aralez Pharmaceuticals Canada、Axsome Therapeutics、Becker Pharmaceutical Consulting、BioDelivery Sciences International、Biohaven、ClearView Healthcare Partners、CoolTech、CRG、Currax、Decision Resources、DeepBench、DRG、Eli Lilly、Equinox、ExpertConnect、GLG、Guidepoint Global Healthcare Consultancy Group、Health Science Communications、HMP Communications、Impel、InteractiveForums、M3 Global Research、Magellan Rx Management、Medicxi、Nordic BioTech、Novartis、Pulmatrix、Reckner Healthcare、Relevale、SAI MedPartners、Satsuma、Slingshot Insights、Spherix Global Insights、Sudler and Hennessey、Synapse Medical Communications、System Analytic、Teva、Theranica、Thought Leader Select、Trinity Partners、XOC、Zosano、Krog and Partners 和 Lundbeck 有关的拨款,在这项工作之外还报告了偏头痛协会、美国头痛协会、克利夫兰诊所基金会、Diamond Headache Clinic、Elsevier、Forefront Collaborative、Hamilton General Hospital、安大略省加拿大、新英格兰头痛合作、亨利福特医院、底特律、Inova、医学学习学院 PeerView、医学教育演讲者网络、Miller Medical Communications、北美 CME 中心、医师教育资源、Rockpointe、ScientiaCME、WebMD/Medscape 的 CME 荣誉。这些结果的摘要和海报在 2020 年 10 月 3 日至 9 日举行的偏头痛信托虚拟研讨会(MTIS)上进行了介绍。