Hospital Clinico Universitario, Universidad Católica de Valencia, Valencia, Spain.
Department of Neurology, Headache Research Unit, Citadelle Hospital, Liège University, Liège, Belgium.
Headache. 2022 Jan;62(1):65-77. doi: 10.1111/head.14234. Epub 2021 Nov 22.
The objective of the study was to assess the tolerability and safety of galcanezumab in patients with chronic cluster headache (CH) with up to 15 months of treatment.
Chronic CH is a highly debilitating disease with a substantial and unmet medical need.
Patients were randomized to receive placebo or galcanezumab (300 mg) monthly for 12 weeks, followed by an optional 52-week open-label extension and 16-week posttreatment follow-up (washout). This is a secondary analysis and long-term follow-up of a previously conducted clinical trial. The safety analysis included patients who received galcanezumab at any time during the study. Outcomes included adverse events (AEs), discontinuations, laboratory values, vital signs, electrocardiograms (ECGs), and suicidality ratings.
A total of 233 patients received at least one galcanezumab dose. The mean exposure was 341 days. Galcanezumab-treated patients were mostly male (n = 169/233; 72.5%) with a mean age of 44.9 (±10.9) years. Treatment-emergent adverse events (TEAEs) were reported by 185 patients (n = 185/233; 79.4%), 23 patients (n = 23/233; 9.9%) reported serious adverse events (SAEs), and 18 patients (n = 18/233; 7.7%) discontinued due to AEs. The SAE CH was reported by three patients. The most common TEAEs (>10%) were nasopharyngitis (n = 41/233; 17.6%) and injection site pain (n = 33/233; 14.2%). 27.5% of patients (n = 64/233) had TEAEs related to injection sites. Likely hypersensitivity events, including injection site rash, injection site urticaria, and injection site hypersensitivity were reported (n = 14/233; 6.0%). There were past histories of suicidal ideation (n = 55/237; 23.2%) and suicidal behavior (n = 9/236; 3.8%). During the study, 15 patients (n = 15/230; 6.5%), seven with previous history, reported suicidal ideation. One patient had a nonfatal suicide attempt during the open-label extension and an aborted attempt during the washout. There were no new safety findings compared with the placebo-controlled treatment period in laboratory values, vital signs, or ECGs.
Galcanezumab 300 mg monthly had a favorable tolerability and safety profile in patients with chronic CH with up to 15 months of treatment.
本研究旨在评估加奈珠单抗治疗慢性丛集性头痛（CH）患者长达 15 个月的耐受性和安全性。
慢性 CH 是一种高度致残性疾病，存在大量未满足的医疗需求。
患者被随机分配接受安慰剂或加奈珠单抗（300mg）每月治疗 12 周，随后进行可选的 52 周开放标签扩展和 16 周治疗后随访（洗脱期）。这是先前进行的临床试验的二次分析和长期随访。安全性分析包括在研究期间任何时候接受加奈珠单抗治疗的患者。结局包括不良事件（AE）、停药、实验室值、生命体征、心电图（ECG）和自杀意念评分。
共有 233 名患者接受了至少一剂加奈珠单抗。平均暴露时间为 341 天。接受加奈珠单抗治疗的患者主要为男性（n=169/233；72.5%），平均年龄为 44.9（±10.9）岁。185 名患者（n=185/233；79.4%）报告了治疗期间出现的不良事件（TEAE），23 名患者（n=23/233；9.9%）报告了严重不良事件（SAE），18 名患者（n=18/233；7.7%）因 AE 而停药。3 名患者报告了 SAE CH。最常见的 TEAEs（>10%）为鼻咽炎（n=41/233；17.6%）和注射部位疼痛（n=33/233；14.2%）。27.5%（n=64/233）的患者出现与注射部位相关的 TEAEs。报告了疑似过敏事件，包括注射部位皮疹、注射部位荨麻疹和注射部位过敏（n=14/233；6.0%）。55 名患者（n=55/237；23.2%）有自杀意念史，9 名患者（n=9/236；3.8%）有自杀行为史。在研究期间，15 名患者（n=15/230；6.5%），其中 7 名有既往病史，报告了自杀意念。1 名患者在开放标签扩展期间发生非致命性自杀企图，在洗脱期发生自杀企图未遂。与安慰剂对照治疗期相比，实验室值、生命体征或心电图均无新的安全性发现。
加奈珠单抗 300mg 每月治疗慢性 CH 患者长达 15 个月，具有良好的耐受性和安全性。
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