将每月头痛天数改善至每月4天或更少，为慢性偏头痛患者提供了具有临床意义的治疗目标。

Improving to Four or Fewer Monthly Headache Days Per Month Provides a Clinically Meaningful Therapeutic Target for Patients with Chronic Migraine.

作者信息

Kaniecki Robert G, Friedman Deborah I, Asher Divya, Hirman Joe, Cady Roger

机构信息

Department of Neurology, University of Pittsburgh School of Medicine, UPMC Headache Center, 120 Lytton Ave, Suite 300, Pittsburgh, PA, 15213, USA.

Departments of Neurology and Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA.

出版信息

Pain Ther. 2023 Oct;12(5):1179-1194. doi: 10.1007/s40122-023-00525-x. Epub 2023 Jun 28.

INTRODUCTION

Treatment target goals for patients receiving preventive migraine treatment are complicated to assess and not achieved by most patients. A headache "number" could establish an understandable treatment target goal for patients with chronic migraine (CM). This study investigates the clinical impact of reduced headache frequency to ≤ 4 monthly headache days (MHDs) as a treatment-related migraine prevention target goal.

METHODS

All treatment arms were pooled for analysis from the PROMISE-2 trial evaluating eptinezumab for the preventive treatment of CM. Patients (N = 1072) received eptinezumab 100 mg, 300 mg, or placebo. Data for the 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and acute medication use days were combined for all post-baseline assessments and analyzed by MHD frequency (≤ 4, 5-9, 10-15, > 15) in the 4 weeks preceding assessment.

RESULTS

Based on pooled data, the percentage of patient-months with ≤ 4 MHDs associated with "very much improved" PGIC was 40.9% (515/1258) versus 22.9% (324/1415), 10.4% (158/1517), and 3.2% (62/1936) of patient-months with 5-9, 10-15, and > 15 MHDs, respectively. Rates of patient-months with ≥ 10 days of acute medication use were 1.9% (21/1111, ≤ 4 MHDs), 4.9% (63/1267, 5-9 MHDs), 49.5% (670/1351, 10-15 MHDs), and 74.1% (1232/1662, > 15 MHDs). Of patient-months with ≤ 4 MHDs, 37.1% (308/830) were associated with "little to none" HIT-6 impairment versus 19.9% (187/940), 10.1% (101/999), and 3.7% (49/1311) of patient-months with 5-9, 10-15, and > 15 MHDs, respectively.

CONCLUSION

Participants improving to ≤ 4 MHDs reported less acute medication use and improved patient-reported outcomes, suggesting that 4 MHDs may be a useful patient-centric treatment target when treating CM.

TRIAL REGISTRATION

ClinicalTrials.gov (Identifier: NCT02974153) ( https://clinicaltrials.gov/ct2/show/NCT02974153 ).

引言

接受偏头痛预防性治疗的患者的治疗目标难以评估，且大多数患者无法实现。头痛“次数”可为慢性偏头痛（CM）患者确立一个易于理解的治疗目标。本研究调查了将头痛频率降低至每月≤4天头痛日（MHD）作为与治疗相关的偏头痛预防目标对临床的影响。

方法

对评估依替奈珠单抗预防性治疗CM的PROMISE - 2试验的所有治疗组进行汇总分析。患者（N = 1072）接受100 mg、300 mg依替奈珠单抗或安慰剂治疗。将6项头痛影响测试（HIT - 6）、患者总体变化印象（PGIC）和急性药物使用天数的数据合并用于所有基线后评估，并在评估前的4周内按MHD频率（≤4、5 - 9、10 - 15、>15）进行分析。

结果

基于汇总数据，与“改善非常大”的PGIC相关的每月MHD≤4天的患者月数百分比为40.9%（515/1258），而每月MHD为5 - 9天、10 - 15天和>15天的患者月数百分比分别为22.9%（324/1415）、10.4%（158/1517）和3.2%（62/1936）。急性药物使用≥10天的患者月数比例分别为1.9%（21/1111，MHD≤4天）、4.9%（63/1267，MHD 5 - 9天）、49.5%（670/1351，MHD 10 - 15天）和74.1%（1232/1662，MHD>15天）。每月MHD≤4天的患者月数中，37.1%（308/830）与“几乎无”HIT - 6损伤相关，而每月MHD为5 - 9天、10 - 15天和>15天的患者月数比例分别为19.9%（187/940）、10.1%（101/999）和3.7%（49/1311）。