Varnado Oralee J, Vu Michelle, Kim Gilwan, Hoyt Margaret, Buysman Erin, Nayyar Abhinav, Anand Shikha, Viktrup Lars
Eli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46285, USA.
Optum Life Sciences, Eden Prairie, MN, USA.
Neurol Ther. 2025 Jun;14(3):911-925. doi: 10.1007/s40120-025-00742-w. Epub 2025 Apr 11.
Migraine, affecting millions globally, imposes a significant burden on patients and healthcare systems. Calcitonin gene-related peptide monoclonal antibodies are recommended as first-line preventive treatments by international guidelines, yet real-world prospective studies comparing their year-long effectiveness to standard of care (SOC) treatments are time-consuming, resource-intense and therefore limited. This study aimed to test the utility of claims data and electronic health records (EHR) by evaluating changes in monthly headache days (MHDs) and disease severity among US patients with migraine receiving galcanezumab versus traditional standard-of-care preventive migraine medications.
A real-world study was conducted using Optum data from US administrative claims and EHR of patients diagnosed with migraine and receiving galcanezumab or SOC. Changes in MHDs over a 24-month follow-up were converted from changes in acute medication using the Pharmacy Quality Alliance (PQA) measure for Migraine Preventive Therapy, and migraine severity was assessed using EHR free text. Data were analyzed using two-sample t-test, chi-square and Fisher exact tests.
Of 63,939 patients with eligible claims, 28,264 (44.2%) had notes in EHR; of those, 227 and 65 patients had information for migraine severity and headache days, respectively. Patients receiving galcanezumab showed significant improvement in MHDs compared to the SOC cohort when assessed using PQA measures (mean [SD] change from baseline to follow-up, - 0.18 [4.76] vs 0.15 [3.85]; p < 0.001). A significantly greater proportion of patients treated with galcanezumab exhibited a 50% reduction (25.9% vs 16.7%; p < 0.001) and 75% reduction (15.7% vs 11.6%; p < 0.001) in MHDs than the standard-of-care cohort. Mean change in migraine severity and MHDs was not determined by EHR because of low sample sizes.
In this exploration of multiple data sources and methodologies, changes in MHDs over 24 months were small in patients treated with galcanezumab or SOC. While real-world data from administrative claims and EHR provided insights, limitations such as small sample sizes for migraine severity data and challenges in extracting clinical outcomes underscore the need for further research.
偏头痛影响着全球数百万人，给患者和医疗系统带来了沉重负担。降钙素基因相关肽单克隆抗体被国际指南推荐为一线预防性治疗药物，但将其长达一年的疗效与标准治疗（SOC）方法进行比较的真实世界前瞻性研究耗时且资源密集，因此数量有限。本研究旨在通过评估接受加卡尼单抗治疗的美国偏头痛患者与接受传统标准预防性偏头痛药物治疗的患者每月头痛天数（MHD）和疾病严重程度的变化，来测试索赔数据和电子健康记录（EHR）的效用。
利用美国行政索赔和EHR中的Optum数据，对诊断为偏头痛并接受加卡尼单抗或SOC治疗的患者进行了一项真实世界研究。使用药房质量联盟（PQA）偏头痛预防性治疗指标，将24个月随访期间MHD的变化从急性药物使用的变化中转换得出，并使用EHR自由文本评估偏头痛严重程度。使用两样本t检验、卡方检验和Fisher精确检验对数据进行分析。
在63939例符合条件的索赔患者中，28264例（44.2%）在EHR中有记录；其中，分别有227例和65例患者有偏头痛严重程度和头痛天数的信息。当使用PQA指标进行评估时，接受加卡尼单抗治疗的患者与SOC队列相比，MHD有显著改善（从基线到随访的平均[标准差]变化，-0.18[4.76]对0.15[3.85]；p<0.001）。与标准治疗队列相比，接受加卡尼单抗治疗的患者中，MHD减少50%（25.9%对16.7%；p<0.001）和减少75%（15.7%对11.6%；p<0.001）的比例显著更高。由于样本量小，EHR未确定偏头痛严重程度和MHD的平均变化。
在这项对多种数据来源和方法的探索中，接受加卡尼单抗或SOC治疗的患者在24个月内MHD的变化很小。虽然来自行政索赔和EHR的真实世界数据提供了见解，但偏头痛严重程度数据样本量小以及提取临床结果方面的挑战等局限性凸显了进一步研究的必要性。
