Barbanti Piero, Aurilia Cinzia, Torelli Paola, Egeo Gabriella, d'Onofrio Florindo, Finocchi Cinzia, Carnevale Antonio, Viticchi Giovanna, Russo Marco, Quintana Simone, Orlando Bianca, Fiorentini Giulia, Messina Roberta, Bartolini Marco, Pistoia Francesca, Filippi Massimo, Bonassi Stefano, Cevoli Sabina, Mannocci Alice
Headache and Pain Unit, IRCCS San Raffaele Roma, Via Della Pisana 235, 00163, Rome, Italy.
San Raffaele University, Rome, Italy.
J Neurol. 2025 Jan 25;272(2):170. doi: 10.1007/s00415-025-12911-w.
To determine whether extending anti-CGRP mAb treatment beyond 3 years influences migraine course, we analyzed migraine frequency during the first month of treatment discontinuation following three 12-month treatment cycles (Ts).
This multicenter, prospective, real-world study enrolled 212 patients with high-frequency episodic migraine (HFEM) or chronic migraine (CM) who completed three consecutive Ts of subcutaneous anti-CGRP mAbs. Discontinuation periods (D1, D2, D3) were defined as the first month after T1, T2, and T3, respectively. The primary endpoint was the ≥ 50% response rate at D3 compared to D2. Secondary endpoints included changes in monthly migraine days (MMD), monthly headache days (MHD), monthly analgesic intake (MAI), numerical rating scale (NRS), Headache Impact Test-6 (HIT-6), ≥ 50% response rate at D3 versus D1 and D2, and relapse rates to CM or medication overuse.
At D3 vs. D2, significant improvements (p < 0.001) were observed in the ≥ 50% response rate (77.8% vs. 53.8%), MMD (- 2.1 ± 1.7), MHD (- 2.9 ± 2.4), MAI (- 2.6 ± 2.4), NRS (- 0.7 ± 1.3), and HIT-6 (- 7.2 ± 5.9), with lower relapse rates to CM (2.3% vs. 18%) and medication overuse (1.3% vs. 10.1%). Compared to D1, D3 demonstrated greater benefits (p < 0.001) in MMD (- 2.6 ± 1.9), MHD (- 5.8 ± 3.3), MAI (- 4.9 ± 3.4), NRS (- 1 ± 1.6), and HIT- 6 (- 9.4 ± 7), alongside higher ≥ 50% response rates (77.8% vs. 25%) and reduced relapses to CM (2.3% vs. 67.7%) and medication overuse (1.3% vs. 34.2%).
Three years of anti-CGRP mAb treatment revealed a progressive increase in the proportion of ≥ 50% responders (D1: 25%; D2: 53.8%; D3: 77.8%) and substantial reductions in migraine burden, suggesting that prolonged treatment may favorably modify migraine course.
为了确定抗降钙素基因相关肽（CGRP）单克隆抗体治疗超过3年是否会影响偏头痛病程，我们分析了在三个12个月治疗周期（T）后停药的第一个月内的偏头痛发作频率。
这项多中心、前瞻性、真实世界研究纳入了212例高频发作性偏头痛（HFEM）或慢性偏头痛（CM）患者，这些患者连续完成了三个皮下注射抗CGRP单克隆抗体的T周期。停药期（D1、D2、D3）分别定义为T1、T2和T3后的第一个月。主要终点是与D2相比，D3时≥50%的缓解率。次要终点包括每月偏头痛天数（MMD）、每月头痛天数（MHD）、每月镇痛药摄入量（MAI）、数字评分量表（NRS）、头痛影响测试-6（HIT-6）、D3与D1和D2相比≥50%的缓解率，以及复发为CM或药物过度使用的发生率。
与D2相比，在D3时，≥50%的缓解率（77.8%对53.8%）、MMD（-2.1±1.7）、MHD（-2.9±2.4）、MAI（-2.6±2.4）、NRS（-0.7±1.3）和HIT-6（-7.2±5.9）有显著改善（p<0.001），复发为CM（2.3%对18%）和药物过度使用（1.3%对10.1%）的发生率降低。与D1相比，D3在MMD（-2.6±1.9）、MHD（-5.8±3.3）、MAI（-4.9±3.4）、NRS（-1±1.6）和HIT-6（-9.4±7）方面有更大益处（p<0.001），同时≥50%的缓解率更高（77.8%对25%），复发为CM（2.3%对67.7%）和药物过度使用（1.3%对34.2%）的发生率降低。
三年的抗CGRP单克隆抗体治疗显示≥50%缓解者的比例逐渐增加（D1：25%；D2：53.8%；D3：77.8%），偏头痛负担大幅减轻，这表明延长治疗可能会对偏头痛病程产生有利影响。
