Department of Neurology, Jefferson Headache Center, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty, University of Duisburg-Essen, Essen, Germany.
Headache. 2021 Oct;61(9):1421-1431. doi: 10.1111/head.14206. Epub 2021 Sep 22.
This post hoc analysis in patients medically diagnosed with chronic migraine (CM) and medication-overuse headache (MOH) evaluated reductions in the use of acute headache medication (AHM) and sustained changes in the diagnostic status of CM and MOH following eptinezumab treatment in the PROMISE-2 study.
Eptinezumab, a monoclonal antibody that inhibits calcitonin gene-related peptide, is approved in the United States for the preventive treatment of migraine. A previous analysis showed that eptinezumab reduced monthly migraine days and was well tolerated in the subgroup of PROMISE-2 patients diagnosed with both CM and MOH.
The phase 3, double-blind, placebo-controlled PROMISE-2 study (NCT02974153) randomized adults with CM to eptinezumab 100 mg, 300 mg, or placebo (administered intravenously every 12 weeks for up to two doses). MOH was prospectively diagnosed at screening by trained physicians based on 3 months of medication history and International Classification of Headache Disorders-3β criteria. This post hoc analysis evaluated changes in total and class-specific days of AHM usage, the percentage of patients using AHM at or above MOH diagnostic thresholds, and the percentage of patients experiencing monthly headache and migraine day frequency below diagnostic thresholds for MOH and/or CM.
In PROMISE-2, 431/1072 (40.2%) patients with CM were diagnosed with MOH (eptinezumab 100 mg, n = 139; 300 mg, n = 147; placebo, n = 145) and were included in this analysis. Total monthly AHM use decreased from 20.6 days/month at baseline to 10.6 days/month over 24 weeks of treatment (49% decrease) with eptinezumab 100 mg, from 20.7 to 10.5 days/month (49% decrease) with eptinezumab 300 mg, and from 19.8 to 14.0 days/month (29% decrease) with placebo. Numerically greater decreases from baseline with eptinezumab were also observed for individual drug classes. In each study month, the percentages of patients who were below MOH thresholds were numerically higher for both eptinezumab doses compared with placebo, as were the percentages of patients experiencing headache and migraine frequency below CM thresholds. Of patients with available data across the entire treatment period, 29.0% (58/200) of patients treated with eptinezumab stopped meeting and remained below diagnostic thresholds for both CM and MOH during Weeks 1-24, as well as 6.3% (6/96) of patients who received placebo.
Across 24 weeks of treatment, eptinezumab reduced AHM use in patients diagnosed with CM and MOH. More than one-fourth (29%) of patients treated with eptinezumab did not meet the diagnostic thresholds for either CM or MOH for the entire treatment period.
本事后分析旨在评估依普替扎umab 治疗后慢性偏头痛（CM）和药物过度使用性头痛（MOH）患者急性头痛药物（AHM）使用量减少和 CM 和 MOH 诊断状态持续变化，这些患者在医学上诊断为慢性偏头痛（CM）和药物过度使用性头痛（MOH）。
依普替扎umab 是一种抑制降钙素基因相关肽的单克隆抗体，已获美国批准用于偏头痛的预防性治疗。先前的一项分析显示，依普替扎umab 可减少每月偏头痛天数，且在 PROMISE-2 患者亚组中耐受性良好，这些患者同时诊断为 CM 和 MOH。
这项 3 期、双盲、安慰剂对照的 PROMISE-2 研究（NCT02974153）将 CM 成年患者随机分配至依普替扎umab 100mg、300mg 或安慰剂组（每 12 周静脉输注一次，最多给药 2 次）。MOH 在筛查时由经过培训的医生根据 3 个月的用药史和国际头痛疾病分类-3β标准前瞻性诊断。本事后分析评估了总用药天数和特定药物类别天数的变化、AHM 使用率达到或超过 MOH 诊断阈值的患者比例，以及每月头痛和偏头痛天数低于 MOH 和/或 CM 诊断阈值的患者比例。
在 PROMISE-2 中，1072 例 CM 患者中有 431 例（40.2%）被诊断为 MOH（依普替扎umab 100mg 组 n=139，300mg 组 n=147，安慰剂组 n=145），并纳入本分析。与基线相比，依普替扎umab 100mg 组、依普替扎umab 300mg 组和安慰剂组的总每月 AHM 使用量分别从 20.6 天/月降至 24 周治疗期间的 10.6 天/月（减少 49%）、20.7 天/月降至 10.5 天/月（减少 49%）和 19.8 天/月降至 14.0 天/月（减少 29%）。与安慰剂相比，依普替扎umab 治疗组也观察到各个药物类别从基线的更大降幅。在每个研究月，与安慰剂相比，依普替扎umab 治疗组有更多患者的 AHm 使用量低于 MOH 阈值，头痛和偏头痛频率低于 CM 阈值的患者比例也更高。在整个治疗期间有可用数据的患者中，29.0%（58/200）接受依普替扎umab 治疗的患者在第 1-24 周停止满足并保持低于 CM 和 MOH 的诊断阈值，而接受安慰剂的患者中则有 6.3%（6/96）。
依普替扎umab 治疗 24 周可减少诊断为 CM 和 MOH 的患者的 AHM 使用量。超过四分之一（29%）接受依普替扎umab 治疗的患者在整个治疗期间均不符合 CM 或 MOH 的诊断标准。
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