Argyriou Andreas A, Dermitzakis Emmanouil V, Xiromerisiou Georgia, Chondrogianni Maria, Foska Aikaterini, Soldatos Panagiotis, Mavraki Eleni, Rikos Dimitrios, Litsardopoulos Pantelis, Tsivgoulis Georgios, Vikelis Michail
Headache Outpatient Clinic; Neurology Department, Agios Andreas General Hospital of Patras, Patras, Greece.
Headache Clinic, Euromedica General Clinic, Thessaloniki, Greece.
Eur J Neurol. 2025 Aug;32(8):e70327. doi: 10.1111/ene.70327.
This study, designed by the Greek Research Alliance for Studying headache and Pain (GRASP), aimed to (i) prospectively evaluate the effects of treatment cessation in fremanezumab-responsive patients after 2 years exposure and (ii) assess variations in response rates after migraine worsening and treatment re-initiation.
We analyzed 149 patients with high-frequency episodic (HFEM) or chronic migraine (CM), who completed 24 months of fremanezumab, and mandatorily paused fremanezumab and re-initiated it after their migraine worsened. To assess longitudinal variations mostly in monthly migraine/headache days (MMD/MHD) and other efficacy variables, patients were interviewed at baseline (T0), at month 3 (T1), month 24 (T2), treatment pause period (T3), and at month 3 after fremanezumab re-initiation (T4). The primary objective was to assess the ≥ 50% and ≥ 75% response rates at T4, compared to T3 and T2.
Migraine relapsed in previous responders at T3, while fremanezumab re-initiation was not equally effective, as evidenced by lower ≥ 50% response rates, mostly in CM. At T4, 6 (9.7%) previously responsive HFEM patients and 27 (31%) previously responsive CM patients failed to obtain ≥ 50% MMD/MHD reduction, compared to T3. The rate of both HFEM and CM super-responders, obtaining a ≥ 75% response at T3, also dropped at T4.
Discontinuation of fremanezumab after month 24 leads to rising MMD/MHDs. After fremanezumab re-initiation, a relatively reduced effectiveness in the first 3 months might occur, compared with the pre-fremanezumab cessation. Overall, our findings doubt the rationale behind mandated anti-CGRP treatment pauses in migraine prophylaxis.
本研究由希腊头痛与疼痛研究联盟（GRASP）设计，旨在（i）前瞻性评估在接受2年治疗后停用fremanezumab对有反应患者的影响，以及（ii）评估偏头痛恶化和重新开始治疗后反应率的变化。
我们分析了149例高频发作性（HFEM）或慢性偏头痛（CM）患者，这些患者完成了24个月的fremanezumab治疗，并在偏头痛恶化后强制停用fremanezumab并重新开始使用。为了评估主要在每月偏头痛/头痛天数（MMD/MHD）和其他疗效变量方面的纵向变化，在基线（T0）、第3个月（T1）、第24个月（T2）、治疗暂停期（T3）以及重新开始使用fremanezumab后第3个月（T4）对患者进行访谈。主要目的是评估与T3和T2相比，T4时≥50%和≥75%的反应率。
在T3时，先前有反应的患者偏头痛复发，而重新开始使用fremanezumab的效果并不相同，≥50%反应率较低，这在CM患者中尤为明显。在T4时，与T3相比，6例（9.7%）先前有反应的HFEM患者和27例（31%）先前有反应的CM患者未能使MMD/MHD降低≥50%。在T3时获得≥75%反应的HFEM和CM超级反应者的比例在T4时也下降了。
在第24个月后停用fremanezumab会导致MMD/MHD增加。重新开始使用fremanezumab后，与停用fremanezumab之前相比，最初3个月的效果可能会相对降低。总体而言，我们的研究结果对偏头痛预防中强制停用抗CGRP治疗背后的原理提出了质疑。
