Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
J Headache Pain. 2018 Nov 8;19(1):105. doi: 10.1186/s10194-018-0927-2.
Migraine prevention with erenumab and migraine induction by calcitonin gene-related peptide (CGRP) both carry notable individual variance. We wanted to explore a possible association between individual efficacy of anti-CGRP treatment and susceptibility to migraine induction by CGRP.
Thirteen migraine patients, previously enrolled in erenumab anti-CGRP receptor monoclonal antibody trials, received CGRP in a double-blind, placebo-controlled, randomized cross-over design to investigate their susceptibility to migraine induction. A standardized questionnaire was used to assess the efficacy of previous antibody treatment. The patients were stratified into groups of high responders and poor responders. Primary outcomes were incidence of migraine-like attacks and area under the curve of headache intensity after infusion of CGRP and placebo. All interviews and experiments were performed in laboratories at the Danish Headache Center, Copenhagen, Denmark.
Ten high responders and three poor responders were included. CGRP induced migraine-like attacks in ten (77%) patients, whereof two were poor responders, compared to none after placebo (p = 0.002). The area under the curve for headache intensity was greater after CGRP, compared to placebo, at 0-90 min (p = 0.009), and 2-12 h (p = 0.014). The median peak headache intensity score was 5 (5-9) after CGRP, compared to 2 (0-4) after placebo (p = 0.004).
Patients with an excellent effect of erenumab are highly susceptible to CGRP provocation. If an association is evident, CGRP provocation could prove a biomarker for predicting antibody treatment efficacy.
Retrospectively registered at clinicaltrials.gov with identifier: NCT03481400 .
依那西普预防偏头痛和降钙素基因相关肽（CGRP）诱导偏头痛均具有显著的个体差异。我们希望探索抗 CGRP 治疗的个体疗效与 CGRP 诱导偏头痛易感性之间的可能关联。
13 名偏头痛患者曾参与依那西普抗 CGRP 受体单克隆抗体试验，他们接受 CGRP 双盲、安慰剂对照、随机交叉设计，以调查他们对偏头痛诱导的易感性。使用标准化问卷评估先前抗体治疗的疗效。患者分为高反应者和低反应者两组。主要结局是 CGRP 和安慰剂输注后偏头痛样发作的发生率和头痛强度曲线下面积。所有访谈和实验均在丹麦哥本哈根丹麦头痛中心的实验室进行。
纳入了 10 名高反应者和 3 名低反应者。CGRP 诱导 10 名（77%）患者出现偏头痛样发作，其中 2 名是低反应者，而安慰剂组无患者出现（p=0.002）。与安慰剂相比，CGRP 后 0-90 分钟（p=0.009）和 2-12 小时（p=0.014）头痛强度曲线下面积更大。CGRP 后头痛强度峰值中位数为 5（5-9），安慰剂组为 2（0-4）（p=0.004）。
依那西普治疗效果极佳的患者对 CGRP 诱发极为敏感。如果存在关联，CGRP 诱发可能成为预测抗体治疗疗效的生物标志物。
在 clinicaltrials.gov 上以标识符 NCT03481400 进行回顾性注册。
