Neurology Department, Headache Unit, Vall d'Hebron, University Hospital and Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain.
Headache and Neurological Pain Research Group, Department de Medicina, Vall d'Hebron, University Hospital and Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain.
BMC Neurol. 2022 Oct 25;22(1):394. doi: 10.1186/s12883-022-02914-9.
Monthly headache frequency directly correlates with personal/societal burden and impacts severity and preventive treatment decisions. This post hoc analysis identified shifts from higher to lower frequency headache categories over 6 months in patients with migraine participating in the PROMISE clinical trials receiving two eptinezumab doses.
Headache frequency at baseline and over study months 1-6 was categorized into 4 groups: chronic migraine (CM; ≥ 15 monthly headache days [MHDs]), high-frequency episodic migraine (HFEM; 10-14 MHDs), low-frequency episodic migraine (LFEM; 4-9 MHDs), and ≤ 3 MHDs. Outcomes included the percentage of patients within each MHD category, the percentage of patients improving by ≥ 1 MHD category, and the number of months with reduction of ≥ 1 MHD category. Data from patients who received approved eptinezumab doses (100 mg or 300 mg) or placebo were included.
Mean headache frequency at baseline in PROMISE-1 was 10 MHDs; most patients were classified as having HFEM (48.6%) or LFEM (43.9%). At Month 1, 62/221 (28.1%), 75/222 (33.8%), and 45/222 (20.3%) patients who received eptinezumab 100 mg, 300 mg, and placebo had ≤ 3 MHDs, with 97/221 (43.9%), 108/222 (48.6%), and 84/222 (37.8%), respectively, falling below the diagnostic EM threshold at Month 6. More than one-third (79/221 [35.7%], 83/222 [37.4%], and 68/222 [30.6%] of patients in the eptinezumab 100 mg, 300 mg, and placebo groups, respectively), had 6 months of reduction of ≥ 1 frequency category. At baseline in PROMISE-2, mean headache frequency was 20.5 MHDs. All patients (100%) in the eptinezumab 100 mg and placebo groups had CM, as did 99.4% of patients receiving eptinezumab 300 mg. At Month 1, 209/356 (58.7%), 216/350 (61.7%), and 167/366 (45.6%) patients treated with eptinezumab 100 mg, 300 mg, and placebo had ≤ 14 MHDs, with 240/356 (67.4%), 249/350 (71.1%), and 221/366 (60.4%), respectively, falling below CM threshold at Month 6. Additionally, 153/356 (43.0%), 169/350 (48.3%), and 116/366 (31.7%) patients in the eptinezumab 100 mg, 300 mg, and placebo groups, respectively, had 6 months of reduction of ≥ 1 frequency category.
In the PROMISE studies, episodic and chronic migraine patients treated with eptinezumab were more likely to reduce their headache frequency versus placebo, which directly and in a sustained way improved their diagnostic category classification.
ClinicalTrials.gov Identifier: NCT02559895, NCT02974153.
每月头痛频率与个人/社会负担直接相关，并影响严重程度和预防性治疗决策。本事后分析旨在确定在偏头痛患者中接受依替扎尼布两种剂量治疗的 PROMISE 临床试验中，从更高头痛频率类别向更低头痛频率类别的转变情况。
根据基线和研究第 1-6 个月的头痛频率将患者分为 4 组：慢性偏头痛（CM；≥15 个每月头痛日[MHD]）、高频发作性偏头痛（HFEM；10-14 MHD）、低频发作性偏头痛（LFEM；4-9 MHD）和≤3 MHD。主要结局包括每个 MHD 类别的患者比例、≥1 MHD 类别的患者比例改善情况，以及≥1 MHD 类别的月数减少情况。包括接受批准的依替扎尼布剂量（100mg 或 300mg）或安慰剂治疗的患者的数据。
PROMISE-1 研究的平均基线头痛频率为 10 MHD；大多数患者被归类为 HFEM（48.6%）或 LFEM（43.9%）。在第 1 个月，221 例患者中有 62 例（28.1%）、222 例中有 75 例（33.8%）和 222 例中有 45 例（20.3%）接受依替扎尼布 100mg、300mg 和安慰剂治疗，其每月头痛日≤3，分别有 97 例（43.9%）、108 例（48.6%）和 84 例（37.8%）在第 6 个月低于偏头痛的诊断标准。超过三分之一（79 例[35.7%]、83 例[37.4%]和 68 例[30.6%]）接受依替扎尼布 100mg、300mg 和安慰剂治疗的患者在 6 个月内头痛频率至少减少了 1 个类别。在 PROMISE-2 研究的基线时，头痛频率为 20.5 MHD。依替扎尼布 100mg 和安慰剂组的所有患者（100%）均患有 CM，依替扎尼布 300mg 组的 99.4%的患者也患有 CM。在第 1 个月，221 例患者中有 209 例（58.7%）、216 例（61.7%）和 167 例（45.6%）接受依替扎尼布 100mg、300mg 和安慰剂治疗，每月头痛日≤14，分别有 240 例（67.4%）、249 例（71.1%）和 221 例（60.4%）在第 6 个月低于 CM 诊断标准。此外，依替扎尼布 100mg、300mg 和安慰剂组分别有 153 例（43.0%）、169 例（48.3%）和 116 例（31.7%）患者在 6 个月内头痛频率至少减少了 1 个类别。
在 PROMISE 研究中，接受依替扎尼布治疗的发作性和慢性偏头痛患者与安慰剂相比，更有可能降低头痛频率，这直接且持续地改善了他们的诊断类别分类。
临床试验.gov 标识符：NCT02559895，NCT02974153。
