Galcanezumab 在预防偏头痛方面的长期疗效：意大利回顾性分析（REALITY）。

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2024-04-01 Epub Date: 2024-02-08 DOI:10.1007/s40120-024-00582-0

Fabrizio Vernieri, Luigi Francesco Iannone, Simona Guerzoni, Antonio Russo, Piero Barbanti, Grazia Sances, Sabina Cevoli, Renata Rao, Carlo Lovati, Anna Ambrosini, Carlotta Buzzoni, Federico Battisti, Laura Vatteone, Steffy Martin Luther King, Federico Torelli

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引用次数: 0

摘要

背景：欧盟（EU）已批准将加康珠单抗作为偏头痛预防药物，用于每月至少有四天偏头痛的成年人。这项回顾性观察研究旨在评估加康珠单抗对偏头痛相关负担的长期疗效，及其对意大利偏头痛预防医疗资源使用的影响：这项回顾性研究的对象是在2019年9月至2020年12月期间开始使用加仑珠单抗预防偏头痛的偏头痛患者。通过病历审查获得了患者每月偏头痛天数（MMD）和急性服药MMD的数据。此外，还收集了患者报告的结果（使用偏头痛残疾评估[MIDAS]问卷和头痛影响测试6[HIT-6]问卷）和医疗资源使用情况的信息。关注的时间点为开始使用加康珠单抗后的1、3、6、9和12个月，以及随访期间可获得的最近时间点：结果：共有 207 名患者参与了研究。从开始治疗后的第3个月起，半数以上患者的MMD至少减少了50%，第3个月时无应答的患者中约有三分之一在第6个月时变成了有应答者。从第 3 个月到第 12 个月，MMD 平均减少了 10 天。在治疗期间，头痛的影响和致残率以及与偏头痛相关的医疗资源利用率均显著下降。临床负担的三个方面（MMDs、MIDAS和急性服药天数）之间也出现了积极的显著关联：这项意大利真实世界研究的结果证实，加康珠单抗起效迅速，对不同偏头痛相关负担的患者均有长期疗效。医疗资源的使用也明显减少。

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Long-Term Effectiveness of Galcanezumab in the Prevention of Migraine: An Italian Retrospective Analysis (REALITY).

Background: Galcanezumab is approved in the European Union (EU) as migraine prophylaxis in adults with at least four migraine days per month. The aim of this retrospective observational study was to evaluate the long-term effectiveness of galcanezumab on migraine-related burdens and its impact on the use of healthcare resources for migraine prophylaxis in an Italian setting.

Methods: This retrospective study was conducted in patients with migraine who initiated treatment with galcanezumab for migraine prevention between September 2019 and December 2020. Patient data for monthly migraine days (MMDs) and MMDs with acute medication intake were obtained by medical chart reviews. Information on patient-reported outcomes (using the Migraine Disability Assessment [MIDAS] questionnaire and Headache Impact Test 6 [HIT-6] questionnaire) and on the use of healthcare resources were also collected. The time points of interest were 1, 3, 6, 9, 12 months after the initiation of galcanezumab, and the most recent time point available during follow-up.

Results: A total of 207 patients were enrolled in the study. Starting from month 3 after treatment initiation, more than half of the patients presented at least a 50% reduction in MMDs, and approximately one-third of non-responders at month 3 became responders at month 6. From month 3 to month 12, MMDs decreased on average by 10 days. Headache impact and disability, as well as migraine-associated health resource utilization decreased significantly during the treatment period. A positive significant association among the three dimensions of clinical burden (MMDs, MIDAS and days of acute medication intake) was also observed.

Conclusion: The results of this Italian real-world study confirmed that galcanezumab has a rapid onset of effect and provides a long-term response among patients over different migraine-related burdens. The use of healthcare resources was also remarkably reduced.

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

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