Abstract：
BACKGROUND: Calcitonin gene-related peptide has shown to play a central role in cluster headache (CH) pathophysiology. A clinical trial with galcanezumab was carried out in chronic cluster headache (CCH) but did not meet its primay endpoint. However, its off-label use in patients with CCH refractory to other therapies could be considered. We aimed to asses the efficacy and safety of galcanezumab as CCH preventive treatment in a real-life setting.
METHODS: An observational study was conducted. Patients with CCH who received at least one dose of 240 mg of galcanezumab.
RESULTS: Twenty-one patients who tried a mean of 6.3 ± 1.9 preventive therapies, including onabotulinumtoxinA in 90.5%. At baseline, the median of frequency was 60 (37.5-105) monthly attacks with 10 (8.3-10) points in pain intensity (Numerical Rating Scale). After one month, the frequency decreased to 31 (10.5-45) (p = 0.003) with 8.5 (8-9.5) intensity (p = 0.007); 10 (47.6%) patients were 50% responders of whom four (19%) were 75% responders. Of the 15 patients with 3 months of follow-up, seven (46.6%) reduced their frequency by 50% and four (26.6%) by 75%, with 40 (10-60) monthly attacks (p = 0.07) and pain intensity of 8 (5-10) (p = 0.026). Some 52% patients experienced adverse events, mostly mild.
CONCLUSIONS: In our cohort of refractory CCH, galcanezumab was effective in almost 50% of patients. This finding supports individual off-label treatment attempts.
METHODS: An observational study was conducted. Patients with CCH who received at least one dose of 240 mg of galcanezumab.
RESULTS: Twenty-one patients who tried a mean of 6.3 ± 1.9 preventive therapies, including onabotulinumtoxinA in 90.5%. At baseline, the median of frequency was 60 (37.5-105) monthly attacks with 10 (8.3-10) points in pain intensity (Numerical Rating Scale). After one month, the frequency decreased to 31 (10.5-45) (p = 0.003) with 8.5 (8-9.5) intensity (p = 0.007); 10 (47.6%) patients were 50% responders of whom four (19%) were 75% responders. Of the 15 patients with 3 months of follow-up, seven (46.6%) reduced their frequency by 50% and four (26.6%) by 75%, with 40 (10-60) monthly attacks (p = 0.07) and pain intensity of 8 (5-10) (p = 0.026). Some 52% patients experienced adverse events, mostly mild.
CONCLUSIONS: In our cohort of refractory CCH, galcanezumab was effective in almost 50% of patients. This finding supports individual off-label treatment attempts.
摘要：
背景：降钙素基因相关肽已显示在丛集性头痛（CH）病理生理学中起重要作用。在慢性丛集性头痛（CCH）中进行了galcanezumab的临床试验，但未达到其最初的终点。然而,可以考虑将其用于对其他疗法无效的CCH患者的标签外使用。我们的目的是在现实生活中评估galcanezumab作为CCH预防性治疗的有效性和安全性。
方法：进行观察性研究。CCH患者接受至少一个剂量的240mggalcanezumab。
结果：21名患者尝试平均6.3±1.9次预防性治疗，其中包括90.5%的单糖霉素A。在基线,频率中位数为每月发作60次(37.5-105次),疼痛强度为10次(8.3-10次)(数值评定量表).一个月后,频率降至31(10.5-45)(p=0.003),强度为8.5(8-9.5)(p=0.007);10(47.6%)例患者为50%应答者,其中4例(19%)为75%应答者.15例患者随访3个月,七个（46.6％）的频率降低了50％，四个（26.6％）的频率降低了75％，每月发作40次（10-60次）（p=0.07），疼痛强度为8次（5-10次）（p=0.026）。约52％的患者出现不良事件，大多温和。
结论：在我们的难治性CCH队列中，galcanezumab在近50%的患者中有效.这一发现支持个人的标签外治疗尝试。
方法：进行观察性研究。CCH患者接受至少一个剂量的240mggalcanezumab。
结果：21名患者尝试平均6.3±1.9次预防性治疗，其中包括90.5%的单糖霉素A。在基线,频率中位数为每月发作60次(37.5-105次),疼痛强度为10次(8.3-10次)(数值评定量表).一个月后,频率降至31(10.5-45)(p=0.003),强度为8.5(8-9.5)(p=0.007);10(47.6%)例患者为50%应答者,其中4例(19%)为75%应答者.15例患者随访3个月,七个（46.6％）的频率降低了50％，四个（26.6％）的频率降低了75％，每月发作40次（10-60次）（p=0.07），疼痛强度为8次（5-10次）（p=0.026）。约52％的患者出现不良事件，大多温和。
结论：在我们的难治性CCH队列中，galcanezumab在近50%的患者中有效.这一发现支持个人的标签外治疗尝试。
