PDF(Pubmed)
Abstract：
BACKGROUND: Cluster headache is a severe and disabling primary headache disorder. Galcanezumab is a monoclonal antibody against calcitonin gene-related peptide and a preventive therapy for episodic cluster headache. However, the approval and insurance coverage for episodic cluster headache differ in each country. Additionally, the consistency of efficacy of galcanezumab therapy has not yet been evaluated. This study aimed to assess the efficacy and safety of 240 mg of galcanezumab therapy for consecutive cluster bouts in patients with episodic cluster headache.
METHODS: The study enrolled patients with episodic cluster headache who received two courses of galcanezumab therapy at three university hospitals in Republic of Korea between February 2020 and April 2022. The efficacy and safety of galcanezumab were analyzed by comparing daily headache frequency, the number of headache days, and headache intensity and adverse effects during the one-week period before and the third week after galcanezumab injection for each episode of cluster bouts. Paired t-test was used for comparing repeated data from different episodes of cluster bout.
RESULTS: Sixteen patients were enrolled in this study. Fourteen patients received galcanezumab therapy for two consecutive cluster bouts. Galcanezumab was administered 24 days and 11 days after the first and second cluster bouts, respectively. The proportion of patients with 50% or more reduction in frequency of daily headache at week 3 from baseline was 86% and 64% during the first and second episodes, respectively. The proportion of patients who received transitional therapy before galcanezumab therapy was higher in the first episode of cluster bout than that in the second episode of cluster bout. No serious adverse reactions or significant differences in adverse effects between cluster bouts were noticed. Two patients received a second galcanezumab therapy during the pre-cluster period, and their cluster periods ended without typical cluster headache attacks 10-60 days after galcanezumab therapy.
CONCLUSIONS: This exploratory analysis suggests that galcanezumab may be effective as a preventive therapy in subsequent cluster bouts. Patients with episodic cluster headaches who underwent galcanezumab therapy tended to receive a second round of treatment in the early stages of their next cluster bout without transitional therapy.
METHODS: The study enrolled patients with episodic cluster headache who received two courses of galcanezumab therapy at three university hospitals in Republic of Korea between February 2020 and April 2022. The efficacy and safety of galcanezumab were analyzed by comparing daily headache frequency, the number of headache days, and headache intensity and adverse effects during the one-week period before and the third week after galcanezumab injection for each episode of cluster bouts. Paired t-test was used for comparing repeated data from different episodes of cluster bout.
RESULTS: Sixteen patients were enrolled in this study. Fourteen patients received galcanezumab therapy for two consecutive cluster bouts. Galcanezumab was administered 24 days and 11 days after the first and second cluster bouts, respectively. The proportion of patients with 50% or more reduction in frequency of daily headache at week 3 from baseline was 86% and 64% during the first and second episodes, respectively. The proportion of patients who received transitional therapy before galcanezumab therapy was higher in the first episode of cluster bout than that in the second episode of cluster bout. No serious adverse reactions or significant differences in adverse effects between cluster bouts were noticed. Two patients received a second galcanezumab therapy during the pre-cluster period, and their cluster periods ended without typical cluster headache attacks 10-60 days after galcanezumab therapy.
CONCLUSIONS: This exploratory analysis suggests that galcanezumab may be effective as a preventive therapy in subsequent cluster bouts. Patients with episodic cluster headaches who underwent galcanezumab therapy tended to receive a second round of treatment in the early stages of their next cluster bout without transitional therapy.
摘要：
背景：丛集性头痛是一种严重且致残的原发性头痛障碍。Galcanezumab是一种抗降钙素基因相关肽的单克隆抗体，是阵发性丛集性头痛的预防疗法。然而,每个国家对偶发性丛集性头痛的批准和保险范围都不同。此外,尚未评估galcanezumab治疗的疗效一致性.这项研究旨在评估240mggalcanezumab治疗连续丛集性头痛患者的疗效和安全性。
方法：该研究纳入了2020年2月至2022年4月在韩国三家大学医院接受两个疗程galcanezumab治疗的阵发性丛集性头痛患者。通过比较每日头痛频率，分析galcanezumab的疗效和安全性。头痛的天数，以及每次丛集性发作注射galcanezumab之前和之后的一周期间的头痛强度和不良反应。配对t检验用于比较来自不同集群发作的重复数据。
结果：本研究纳入了16例患者。14名患者接受galcanezumab治疗连续两次集群发作。在第一次和第二次集群发作后24天和11天给予Galcanezumab，分别。在第1和第2次发作期间，第3周时每日头痛频率比基线降低50%或更多的患者比例分别为86%和64%。分别。在第一次聚集性发作中，在galcanezumab治疗之前接受过渡性治疗的患者比例高于第二次聚集性发作。没有发现严重的不良反应或集群之间的不良反应存在显着差异。两名患者在集群前接受了第二次galcanezumab治疗，在galcanezumab治疗后10-60天，他们的集群期结束，没有典型的丛集性头痛发作。
结论：这项探索性分析表明，galcanezumab在随后的集群发作中作为预防性治疗可能是有效的。接受galcanezumab治疗的偶发性丛集性头痛患者倾向于在下一次集群发作的早期阶段接受第二轮治疗，而无需过渡性治疗。
方法：该研究纳入了2020年2月至2022年4月在韩国三家大学医院接受两个疗程galcanezumab治疗的阵发性丛集性头痛患者。通过比较每日头痛频率，分析galcanezumab的疗效和安全性。头痛的天数，以及每次丛集性发作注射galcanezumab之前和之后的一周期间的头痛强度和不良反应。配对t检验用于比较来自不同集群发作的重复数据。
结果：本研究纳入了16例患者。14名患者接受galcanezumab治疗连续两次集群发作。在第一次和第二次集群发作后24天和11天给予Galcanezumab，分别。在第1和第2次发作期间，第3周时每日头痛频率比基线降低50%或更多的患者比例分别为86%和64%。分别。在第一次聚集性发作中，在galcanezumab治疗之前接受过渡性治疗的患者比例高于第二次聚集性发作。没有发现严重的不良反应或集群之间的不良反应存在显着差异。两名患者在集群前接受了第二次galcanezumab治疗，在galcanezumab治疗后10-60天，他们的集群期结束，没有典型的丛集性头痛发作。
结论：这项探索性分析表明，galcanezumab在随后的集群发作中作为预防性治疗可能是有效的。接受galcanezumab治疗的偶发性丛集性头痛患者倾向于在下一次集群发作的早期阶段接受第二轮治疗，而无需过渡性治疗。
