Headache and Neurosonology Unit, Neurology, Fondazione Policlinico Campus Bio-Medico, Rome, Italy.
San Raffaele University, Rome, Italy.
Headache. 2022 Oct;62(9):1143-1147. doi: 10.1111/head.14400. Epub 2022 Oct 7.
This prospective cohort, real-life study aimed to evaluate whether galcanezumab, a monoclonal antibody anti-calcitonin gene-related peptide (CGRP) ligand, can reduce caregivers' distress and improve their mutuality with patients.
Migraine is a highly disabling chronic disease that negatively impacts patients' and often their relatives' lives, occurring during an active phase of life with direct consequences on leisure- and work-related activities. The figure of caregiver is crucial in several neurological conditions but poorly accounted for in migraine care so far. Studies on monoclonal antibodies against the CGRP pathway, recently introduced as migraine-preventive treatments, demonstrated that they significantly reduce migraine frequency and disability in the first weeks of treatment.
Consecutive patient-caregiver dyads were evaluated at baseline and after 6 months of treatment with galcanezumab (V6) at our headache center from September 2020 to September 2021. Enrolled patients were requested to report their monthly migraine days, monthly intake of acute medications, attack pain intensity (on the Numeric Rating Scale), concomitant preventives, and disability questionnaires (Headache Impact Test, Migraine Disability Assessment). Each dyad filled in the Mutuality Scale to check their reciprocity; moreover, the Relatives' Stress Scale was used to detect caregivers' distress.
We enrolled 27 patient-caregiver dyads. At 6 months, migraine burden significantly improved with reductions in monthly migraine days (falling from 14.8 [SD = 4.8] days by 10.3 [SD = 4.8] days; 95% CI: 8.4, 12.2; p < 0.001) and Migraine Disability Assessment scores (lowering from 83.6 [SD = 46.7] by 71.5 points [SD = 49.3]; 95% CI: 51.2, 91.9; p < 0.001). From baseline to month 6, the caregiver Relatives' Stress Scale score significantly decreased (falling from 20.7 [SD = 13.7] by 6.5 [SD = 14.1] points; 95% CI: 0.8, 12.2; p = 0.027), while the Mutuality Scale's caregiver total score increased (from 3.04 [SD = 0.61] by 0.29 [SD = 0.49] points; 95% CI: -0.508, -0.064; p = 0.014).
Our findings preliminarily demonstrated that patients' migraine improvement after 6 months of galcanezumab treatment could be favorably perceived by caregivers, significantly reducing their distress with better reciprocity within the dyad.
本前瞻性队列研究旨在评估降钙素基因相关肽（CGRP）配体单克隆抗体加奈珠单抗是否可以减轻照料者的痛苦并改善他们与患者之间的相互关系。
偏头痛是一种高度致残的慢性疾病，会对患者及其亲属的生活造成负面影响，且常发生在生活活跃期，直接影响休闲和工作相关活动。照料者的角色在许多神经疾病中至关重要，但迄今为止在偏头痛护理中并未得到充分重视。针对 CGRP 通路的单克隆抗体的研究最近被作为偏头痛预防治疗方法引入，表明它们在治疗的最初几周内可显著减少偏头痛的发作频率和残疾程度。
我们从 2020 年 9 月至 2021 年 9 月在头痛中心连续评估了接受加奈珠单抗（V6）治疗的 27 对患者-照料者。要求入组患者报告他们每月的偏头痛天数、每月急性药物摄入、头痛发作时的疼痛强度（数字评分量表）、同时使用的预防药物和残疾问卷（头痛影响测试、偏头痛残疾评估）。每对患者和照料者填写相互量表以检查他们的互惠性；此外，还使用亲属压力量表来检测照料者的压力。
我们共纳入了 27 对患者-照料者。在 6 个月时，偏头痛负担显著改善，每月偏头痛天数减少（从 14.8[标准差=4.8]天减少到 10.3[标准差=4.8]天；95%置信区间：8.4，12.2；p<0.001），偏头痛残疾评估评分降低（从 83.6[标准差=46.7]分降低到 71.5 分[标准差=49.3]；95%置信区间：51.2，91.9；p<0.001）。从基线到第 6 个月，照料者亲属压力量表评分显著下降（从 20.7[标准差=13.7]分降低到 6.5[标准差=14.1]分；95%置信区间：0.8，12.2；p=0.027），而相互量表的照料者总分增加（从 3.04[标准差=0.61]分增加到 3.33[标准差=0.49]分；95%置信区间：-0.508，-0.064；p=0.014）。
我们的研究结果初步表明，加奈珠单抗治疗 6 个月后患者偏头痛的改善可能会被照料者积极感知，这显著减轻了他们的痛苦，同时改善了他们之间的相互关系。
