Krymchantowski Abouch, Jevoux Carla, Silva-Néto Raimundo P, Soares Adriana A, Pimentel Maria Lucia Vellutini, Krymchantowski Ana Gabriela, Júnior Hilton Mariano da Silva, Cotrik Ervin Michelstaedter
Department of Post-graduation in Neurology, Headache Center of Rio, Rio de Janeiro, BRA.
Department of Neurology, Headache Center of Rio, Rio de Janeiro, BRA.
Cureus. 2025 Mar 10;17(3):e80345. doi: 10.7759/cureus.80345. eCollection 2025 Mar.
Monoclonal antibodies (mAbs) for anti-calcitonin gene-related peptide (CGRP) have emerged as an effective and well-tolerated option for alleviating migraine burden and improving patients' quality of life. There is limited understanding of the specific clinical and biological predictors that forecast sustained response to anti-CGRP antibodies in real-world episodic migraine patients. This study was designed to estimate the proportion and potential predictors of response (≥50% response rate) at two months and four months in real-world patients with episodic migraine who received this therapy as their only preventive treatment.
This is an open prospective study carried out in consecutive episodic migraine patients (International Classification of Headache Disorders (ICHD)-3) with six to 10 monthly headache days (MHD), seen for the first time from January 2023 to May 2024 in a tertiary center, to whom a monoclonal antibody anti-CGRP (fremanezumab or galcanezumab) was prescribed as the only preventive treatment. Sixty-three patients fulfilled the eligibility criteria. The patients were evaluated in long-lasting initial consultations, and follow-up visits were carried out after two and four months. Data was collected using a semi-structured proforma and a detailed headache diary.
There was a significant reduction in the migraine frequency as measured by MHD from baseline to two months and four months after intervention (P=0.000, 8.85±1.17 days at baseline to 6.39±3.60 at two months and 6.35±3.25 at four months). The reduction in MHD was significantly higher among those who had a normal BMI as compared to the participants who were overweight (P=0.000) and those who had unilateral headaches (P=0.013) and severe osmophobia during attacks (P=0.035). Approximately 39.7% (n=25) of participants achieved a ≥50% reduction in MHD at both two and four months.
Normal BMI was found to be significantly associated with a reduction in migraine frequency of >50%, whereas normal BMI, unilateral headache, and severe osmophobia were significantly associated with a mean MHD reduction. Further controlled studies with several other factors predicting response to anti-CGRP mAbs are warranted.
抗降钙素基因相关肽（CGRP）单克隆抗体（mAbs）已成为减轻偏头痛负担和改善患者生活质量的一种有效且耐受性良好的选择。对于现实世界中发作性偏头痛患者对抗CGRP抗体持续反应的具体临床和生物学预测因素，人们了解有限。本研究旨在评估在现实世界中仅接受这种疗法作为预防性治疗的发作性偏头痛患者在两个月和四个月时的反应比例（反应率≥50%）及潜在预测因素。
这是一项开放性前瞻性研究，纳入2023年1月至2024年5月在一家三级中心首次就诊的连续发作性偏头痛患者（国际头痛疾病分类（ICHD）-3），每月头痛天数（MHD）为6至10天，给予抗CGRP单克隆抗体（fremanezumab或galcanezumab）作为唯一预防性治疗。63例患者符合纳入标准。患者在长时间的初次咨询中接受评估，并在两个月和四个月后进行随访。使用半结构化表格和详细的头痛日记收集数据。
干预后从基线到两个月和四个月，以MHD衡量的偏头痛频率显著降低（P = 0.000，基线时8.85±1.17天，两个月时6.39±3.60天，四个月时6.35±3.25天）。与超重参与者（P = 0.000）、有单侧头痛的参与者（P = 0.013）以及发作时严重畏光的参与者（P = 0.035）相比，BMI正常者的MHD降低幅度显著更大。约39.7%（n = 25）的参与者在两个月和四个月时MHD均降低≥50%。
发现正常BMI与偏头痛频率降低>50%显著相关，而正常BMI、单侧头痛和严重畏光与平均MHD降低显著相关。有必要对预测抗CGRP mAbs反应的其他几个因素进行进一步的对照研究。
