School of Medicine, Neurology Department, Acibadem University, Büyükdere Caddesi. No: 40, Istanbul, 34390, Turkey.
Private practice, Istanbul, Turkey.
BMC Neurol. 2023 Nov 23;23(1):418. doi: 10.1186/s12883-023-03467-1.
The complexity of clinical practice extends far beyond the controlled settings of trials, and there is a need for real-world studies aimed at identifying which patients will respond to anti-CGRP monoclonal antibodies in different countries. This study aimed to investigate the efficacy and safety of galcanezumab in treating migraine in a real-life setting in Turkey, as well as identify predictors of treatment response.
A total of 476 patients who diagnosed with migraine according to ICHD-3 criteria and treated with galcanezumab by headache specialists were voluntarily participated in this cross-sectional study. Galcanezumab is indicated for the prevention of migraine in adults who have at least 4 monthly migraine days in Turkey. All patients filled out a survey on Google Form that comprised 54 questions, addressing various aspects such as demographics, migraine characteristics, previous use of acute symptomatic medication, failures with preventive drug classes, comorbidities, most bothersome symptoms, as well as the interictal burden of migraine.
Among the participants, 89.3% reported that galcanezumab treatment was beneficial for them. A decrease in the frequency (80.0%), severity (85.7%), and acute medication usage for migraine attacks (71.4%) was reported with galcanezumab treatment. An adverse effect related to galcanezumab was reported in 16.3% of cases, but no serious adverse reactions were observed. Remarkably, 14.3% of participants reported no longer experiencing any headaches, and 18.9% did not require any acute treatment while receiving galcanezumab treatment. A logistic regression model showed that male gender, lack of ictal nausea, and previous failure of more than 2 prophylactic agents may predict the non-responders.
The first large series from Turkey showed that galcanezumab treatment is safe and effective in most of the patients diagnosed with migraine by headache experts in the real-life setting. Patients reported a significant decrease in both ictal and interictal burden of migraine and expressed satisfaction with this treatment.
临床实践的复杂性远远超出了试验的受控环境，因此需要进行真实世界的研究，以确定在不同国家哪些患者对抗 CGRP 单克隆抗体有反应。本研究旨在调查加奈珠单抗在土耳其真实环境中治疗偏头痛的疗效和安全性，并确定治疗反应的预测因素。
根据 ICHD-3 标准诊断为偏头痛的 476 例患者，由头痛专家给予加奈珠单抗治疗，自愿参加这项横断面研究。加奈珠单抗在土耳其被批准用于预防偏头痛，适用于每月偏头痛发作至少 4 天的成年人。所有患者都在 Google 表单上填写了一份包含 54 个问题的调查问卷，涵盖了人口统计学、偏头痛特征、以前使用急性对症药物、预防药物类别的失败、合并症、最困扰的症状以及偏头痛的间歇期负担等各个方面。
参与者中 89.3%报告加奈珠单抗治疗对他们有益。与治疗前相比，偏头痛发作的频率（80.0%）、严重程度（85.7%）和急性药物使用（71.4%）均有所下降。16.3%的病例报告了与加奈珠单抗相关的不良反应，但未观察到严重不良反应。值得注意的是，14.3%的参与者报告不再出现任何头痛，18.9%在接受加奈珠单抗治疗时无需任何急性治疗。逻辑回归模型显示，男性、无发作性恶心以及之前使用超过 2 种预防药物失败可能预测为无反应者。
来自土耳其的第一项大型系列研究表明，加奈珠单抗治疗在真实环境中由头痛专家诊断为偏头痛的大多数患者中是安全有效的。患者报告偏头痛的发作期和间歇期负担均显著减轻，并对这种治疗表示满意。
