Eli Lilly Italia, Sesto Fiorentino, Italy.
California Medical Clinic for Headache, Santa Monica, CA, USA.
BMC Neurol. 2018 Nov 9;18(1):188. doi: 10.1186/s12883-018-1193-2.
Galcanezumab, a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide, has demonstrated in previous Phase 2 and Phase 3 clinical studies (≤6-month of treatment) a reduction in the number of migraine headache days and improved patients' functioning. This study evaluated the safety and tolerability, as well as the effectiveness of galcanezumab for up to 12 months of treatment in patients with migraine.
Patients diagnosed with episodic or chronic migraine, 18 to 65 years old, that were not exposed previously to galcanezumab, were randomized to receive galcanezumab 120 mg or 240 mg, administered subcutaneously once monthly for a year. Safety and tolerability were evaluated by frequency of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to study discontinuation. Laboratory values, vital signs, electrocardiograms, and suicidality were also analyzed. Additionally, overall change from baseline in the number of monthly migraine headache days, functioning, and disability were assessed.
One hundred thirty five patients were randomized to each galcanezumab dose group. The majority of patients were female (> 80%) and on average were 42 years old with 10.6 migraine headache days per month at baseline. 77.8% of the patients completed the open-label treatment phase, 3.7% of patients experienced an SAE, and 4.8% discontinued due to AEs. TEAEs with a frequency ≥ 10% of patients in either dose group were injection site pain, nasopharyngitis, upper respiratory tract infection, injection site reaction, back pain, and sinusitis. Laboratory values, vital signs, or electrocardiograms did not show anyclinically meaningful differences between galcanezumab dosesOverall mean reduction in monthly migraine headache days over 12 months for the galcanezumab dose groups were 5.6 (120 mg) and 6.5 (240 mg). Level of functioning was improved and headache-related disability was reduced in both dose groups.
Twelve months of treatment with self-administered injections of galcanezumab was safe and associated with a reduction in the number of monthly migraine headache days. Safety and tolerability of the 2 galcanezumab dosing regimens were comparable.
ClinicalTrials.gov as NCT02614287 , posted November 15, 2015. These data were previously presented as a poster at the International Headache Congress 2017: PO-01-184, Late-Breaking Abstracts of the 2017 International Headache Congress. (2017). Cephalalgia, 37(1_suppl), 319-374.
加奈珠单抗是一种人源化单克隆抗体，能选择性地与降钙素基因相关肽结合。在之前的 2 期和 3 期临床研究（≤6 个月的治疗）中，它已显示出可减少偏头痛头痛天数并改善患者的功能。本研究评估了加奈珠单抗治疗偏头痛长达 12 个月的安全性和耐受性，以及有效性。
年龄在 18 至 65 岁之间、被诊断为发作性或慢性偏头痛、以前未接触过加奈珠单抗的患者，被随机分配接受加奈珠单抗 120mg 或 240mg，每月皮下注射一次，为期一年。通过治疗中出现的不良事件（TEAE）、严重不良事件（SAE）和导致研究终止的不良事件（AE）的频率来评估安全性和耐受性。还分析了实验室值、生命体征、心电图和自杀意念。此外，还评估了基线时每月偏头痛头痛天数、功能和残疾总体变化情况。
135 名患者被随机分配到每个加奈珠单抗剂量组。大多数患者为女性（>80%），平均年龄为 42 岁，基线时每月偏头痛头痛天数为 10.6 天。77.8%的患者完成了开放性治疗阶段，3.7%的患者发生了 SAE，4.8%的患者因 AE 而退出。两个剂量组中，发生率≥10%的患者出现的治疗相关不良事件包括注射部位疼痛、鼻咽炎、上呼吸道感染、注射部位反应、背痛和鼻窦炎。实验室值、生命体征或心电图在加奈珠单抗剂量组之间均未显示出任何有临床意义的差异。两组的平均每月偏头痛头痛天数在 12 个月的治疗中均有减少，分别为 5.6（120mg）和 6.5（240mg）。两个剂量组的功能水平都有所改善，头痛相关残疾也有所减轻。
自行注射加奈珠单抗治疗 12 个月是安全的，并可减少每月偏头痛头痛天数。两种加奈珠单抗给药方案的安全性和耐受性相当。
ClinicalTrials.gov 登记号为 NCT02614287，于 2015 年 11 月 15 日注册。这些数据曾以海报形式在 2017 年国际头痛大会上展示（PO-01-184，2017 年国际头痛大会最新摘要）。（2017 年）。头痛杂志，37（1 增刊），319-374。
