Geisel School of Medicine at Dartmouth, Hanover, NH, USA.
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
J Headache Pain. 2021 Apr 19;22(1):27. doi: 10.1186/s10194-021-01238-2.
Migraine is one of the leading causes of disability worldwide. Erenumab is a fully human monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) receptor. This study aimed to evaluate real-world evidence on the impact of erenumab on acute medication usage and health care resource utilization (HCRU) among migraine patients.
This retrospective effectiveness study utilized the US Optum's de-identified Clinformatics® Data Mart database to identify migraine patients initiating erenumab between May 1, 2018 and September 30, 2019. Patients had to be at least 18 years old, with a minimum of three doses for erenumab in the 6-month post-index period and continuous medical/pharmacy coverage in the 12-month pre- and 6-month post-index period. The date of the first claim for erenumab served as the index date. Use of acute medications overall and at different drug class level, and HCRU were compared during the 6-month pre- vs. post-index period. Impact of erenumab on a composite endpoint of three possible events: 1) outpatient visit with a diagnosis of migraine and an associated acute medication claim within 7 days of the visit, 2) hospital admission with a primary diagnosis for migraine, or 3) emergency room visit with a primary diagnosis for migraine (any events that occurred ≤3 days apart were counted only once) was also evaluated.
The analysis included 3171 identified patients. At 6 months, following initiation of erenumab, acute medication use including the number of types of acute medication, number of claims of each medication and % of patients who received acute medication, and HCRU were significantly decreased. For the composite outcome, the mean number of events decreased from 1.03 to 0.77 (rate ratio: 0.75; 95% CI: 0.71 to 0.79; P < 0.0001). A decrease in the proportion of patients with any of the three events was also observed (52.7% vs. 39.5%, P < 0.0001).
In this retrospective analysis, erenumab was associated with significantly reduced acute medication use and HCRU in a real-world setting, hence significantly reducing the burden of the disease. A composite endpoint could be used as a proxy to evaluate the burden of migraine attacks; however, further research is needed.
偏头痛是全球主要致残原因之一。依瑞奈单抗是一种靶向降钙素基因相关肽（CGRP）受体的全人源单克隆抗体。本研究旨在评估依瑞奈单抗对偏头痛患者急性药物使用和医疗保健资源利用（HCRU）的实际影响的真实世界证据。
本回顾性有效性研究利用美国 Optum 的去识别 Clinformatics® Data Mart 数据库，确定 2018 年 5 月 1 日至 2019 年 9 月 30 日期间开始使用依瑞奈单抗的偏头痛患者。患者必须年满 18 岁，在索引后 6 个月内至少使用依瑞奈单抗 3 剂，并且在索引前 12 个月和后 6 个月内持续有医疗/药房覆盖。依瑞奈单抗的首次索赔日期作为索引日期。在 6 个月的预索引和后索引期间，比较总体和不同药物类别水平的急性药物使用情况以及 HCRU。还评估了依瑞奈单抗对三个可能事件的复合终点的影响：1）就诊时诊断为偏头痛并在就诊后 7 天内伴有急性药物索赔的门诊就诊，2）原发性偏头痛住院，或 3）急诊室就诊，以偏头痛为主要诊断（任何发生在 ≤3 天内的事件仅计算一次）。
分析包括 3171 名确定的患者。在开始使用依瑞奈单抗后的 6 个月内，急性药物使用包括急性药物的类型数量、每种药物的索赔数量以及接受急性药物的患者比例，以及 HCRU 均显著降低。对于复合结局，事件的平均数量从 1.03 减少到 0.77（率比：0.75；95%CI：0.71 至 0.79；P<0.0001）。也观察到任何三种事件中患者比例的下降（52.7%对 39.5%，P<0.0001）。
在这项回顾性分析中，依瑞奈单抗与现实环境中急性药物使用和 HCRU 的显著减少相关，从而显著减轻了疾病负担。复合终点可用作评估偏头痛发作负担的替代指标；然而，需要进一步的研究。
