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丛集性头痛与加卡奈珠单抗:巴西的首个真实世界研究及关于其在其他治疗方法中应用的专家共识。

Cluster headache and galcanezumab: the first real-world Brazilian study and an expert consensus on its use among other treatments.

作者信息

Krymchantowski Abouch, Jevoux Carla, Piovesan Élcio Juliato, Valença Marcelo Moraes, Kowacs Fernando, Kowacs Pedro André, Dach Fabíola, Monzillo Paulo Hélio, Bordini Carlos Alberto, Silva-Néto Raimundo Pereira

机构信息

Headache Center of Rio, Rio de Janeiro, Brazil.

Pontifícia Universidade Católica do Rio de Janeiro (PUC-Rio), Rio de Janeiro, Brazil.

出版信息

J Headache Pain. 2024 Dec 3;25(1):211. doi: 10.1186/s10194-024-01909-w.

Abstract

OBJECTIVE

To present the first Brazilian real-world results with galcanezumab and provide a consensus expert opinion on the prophylactic treatment of cluster headache (CH) in Brazil.

METHODS

The first part of the study (real-world results) was observational, prospective, uncontrolled, and descriptive. A sample of 44 consecutive patients with episodic or chronic CH were evaluated and treated in a traditional tertiary clinic from March 2020 to June 2024. The second part (consensus expert opinion) consisted of a survey completed by ten Brazilian headache clinicians with at least 25 years of clinical experience, who published at least 15 headache papers and attended at least 15 national or international headache conferences.

RESULTS

Forty-four patients (86.4% men, 13.6% women) were included. The average age was 45.9 ± 14.2 years. The diagnosis was made 27.3 ± 13.6 years after the onset of headache bouts. In 84.1% of the patients, CH was classified as episodic. Verapamil, lithium, or verapamil plus lithium were prescribed to respectively, 25%, 9.1%, and 6.8% of patients. Galcanezumab was prescribed to all and the majority (65.9%) used a dose of 300 mg once. There was a reduction in headache frequency of ≥ 50% at 3 weeks in 65.9% of patients for all doses of galcanezumab, and in 72.4% of those using galcanezumab 300 mg. Verapamil was recommended as a first-line treatment by 6 of 10 experts and a second-line treatment by the other 4 experts; galcanezumab was recommended as a first-line treatment by 4 of 10 experts and as a second-line treatment by 3 of 10 experts.

CONCLUSIONS

This study presented the first real-world data with galcanezumab in Brazilian patients with CH and showed a reduction in headache frequency in most patients. A survey of Brazilian experts not meant to represent the country's guidelines, favored galcanezumab as either the first or the second option in prophylaxis. Collectively, these results highlighted galcanezumab's promising efficacy as a new tool in CH patients.

摘要

目的

展示加卡尼单抗在巴西的首批真实世界研究结果,并就巴西丛集性头痛(CH)的预防性治疗提供专家共识意见。

方法

研究的第一部分(真实世界研究结果)为观察性、前瞻性、非对照性和描述性研究。2020年3月至2024年6月期间,在一家传统的三级诊所对44例连续性发作性或慢性CH患者进行了评估和治疗。第二部分(专家共识意见)包括一项由十位巴西头痛病临床医生完成的调查,这些医生具有至少25年的临床经验,发表过至少15篇头痛病相关论文,并参加过至少15次国内或国际头痛病会议。

结果

纳入44例患者(男性占86.4%,女性占13.6%)。平均年龄为45.9±14.2岁。头痛发作后27.3±13.6年确诊。84.1%的患者CH被分类为发作性。分别有25%、9.1%和6.8%的患者使用了维拉帕米、锂盐或维拉帕米加锂盐。所有患者均使用了加卡尼单抗,大多数患者(65.9%)使用300mg单次剂量。所有剂量的加卡尼单抗治疗3周时,65.9%的患者头痛频率降低≥50%,使用300mg加卡尼单抗的患者中这一比例为72.4%。10位专家中有6位推荐维拉帕米作为一线治疗,另外4位专家推荐其作为二线治疗;10位专家中有4位推荐加卡尼单抗作为一线治疗,3位专家推荐其作为二线治疗。

结论

本研究展示了加卡尼单抗在巴西CH患者中的首批真实世界数据,并显示大多数患者头痛频率降低。一项针对巴西专家的调查(并非代表该国指南)倾向于将加卡尼单抗作为预防性治疗的首选或次选方案。总体而言,这些结果突出了加卡尼单抗作为CH患者新治疗手段的潜在疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/714d/11613734/7e4775938fc8/10194_2024_1909_Fig1_HTML.jpg

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