De Praeter Ruben, Tuerlinckx Evelien, Schoenen Jean, Boon Elizabet, Sava Simona Liliana, Debruyne Frederik, Delmotte Koen, De Pauw Adinda, Van Dycke Annelies, Van Humbeeck Cindy, Versijpt Jan
Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium.
Citadelle Hospital-Algology and GIGA-Neuroscience, University of Liège, Liège, Belgium.
Acta Neurol Belg. 2025 Apr 11. doi: 10.1007/s13760-025-02782-3.
Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway have emerged as a promising preventive treatment for migraine. In Belgium, patients receiving these antibodies must adhere to a mandatory treatment holiday of three months. This study investigated the patients' experiences during this treatment holiday.
A prospective study was conducted among 243 patients from nine headache clinics in Belgium receiving treatment with erenumab, fremanezumab or galcanezumab. Participants completed a structured questionnaire during their yearly follow-up visit after the treatment holiday. The questionnaire assessed the subjective migraine evolution and anxiety levels, and perceived usefulness of the treatment holiday.
The majority of patients (86.0%) reported worsening of migraine symptoms during the treatment holiday, 59.4% of them experiencing deterioration already within the first month. For 5.9% of patients, this occurred beyond the 3-month mandatory holiday period, delaying treatment resumption. Improvement was reported by 3.0% of patients, while 11.0% experienced no change. Anxiety surrounding the treatment holiday was reported by 45.0% of participants, with 18.6% experiencing very high levels of anxiety. A significant association was found between anxiety and subjective migraine deterioration (p = 0.012). Nearly half (49.1%) of the respondents found the drug holiday overall useful in gaining insight into the need for continued treatment, 22.6% considered it even very useful.
A rigid, mandatory treatment holiday of two to three months poses significant challenges for a substantial subset of patients, leading to rapid migraine deterioration and increased anxiety. The observed association between migraine deterioration and anxiety highlights the need for patient education strategies. Policy makers should consider these findings to develop more flexible, patient-centered treatment approaches that optimize outcomes.
靶向降钙素基因相关肽（CGRP）通路的单克隆抗体已成为偏头痛一种有前景的预防性治疗方法。在比利时，接受这些抗体治疗的患者必须遵守为期三个月的强制治疗假期。本研究调查了患者在这个治疗假期期间的经历。
对来自比利时九家头痛诊所的243例接受erenumab、fremanezumab或galcanezumab治疗的患者进行了一项前瞻性研究。参与者在治疗假期后的年度随访期间完成了一份结构化问卷。该问卷评估了主观偏头痛演变、焦虑水平以及对治疗假期的感知有用性。
大多数患者（86.0%）报告在治疗假期期间偏头痛症状恶化，其中59.4%的患者在第一个月内就出现了症状恶化。5.9%的患者在三个月的强制假期之后症状恶化，从而推迟了治疗恢复。3.0%的患者报告症状有所改善，而11.0%的患者无变化。45.0%的参与者报告了围绕治疗假期的焦虑，其中18.6%的人焦虑程度非常高。焦虑与主观偏头痛恶化之间存在显著关联（p = 0.012）。近一半（49.1%）的受访者认为药物假期总体上有助于深入了解是否需要继续治疗，22.6%的人甚至认为非常有用。
两到三个月的严格强制治疗假期给相当一部分患者带来了重大挑战，导致偏头痛迅速恶化和焦虑增加。偏头痛恶化与焦虑之间的关联凸显了患者教育策略的必要性。政策制定者应考虑这些发现，以制定更灵活、以患者为中心的治疗方法，从而优化治疗效果。
