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Neurophysiological and biomolecular effects of erenumab in chronic migraine: An open label study.
Cephalalgia ( IF 4.9 ) Pub Date : 2020-07-26 , DOI: 10.1177/0333102420942230
Roberto De Icco 1, 2 , Giuseppe Fiamingo 1, 2 , Rosaria Greco 3 , Sara Bottiroli 1, 4 , Chiara Demartini 3 , Anna Maria Zanaboni 2, 3 , Marta Allena 1 , Elena Guaschino 1 , Daniele Martinelli 1, 2 , Alessia Putortì 1, 2 , Valentina Grillo 1 , Grazia Sances 1 , Cristina Tassorelli 1, 2
Affiliation  

Introduction

Anti-calcitonin gene-related peptide antibodies proved effective in the preventive treatment of chronic migraine. In this open label study, we aim to assess the effects of erenumab administration on neurophysiological and biomolecular profiles in a representative cohort of chronic migraine patients.

Methods

Forty patients with a history of chronic migraine for at least 12 months prior to enrollment, and previous failure of at least two different preventive therapies, were enrolled. After a 1-month observation period (T0), patients were treated with erenumab 70 mg s.c. (every 28 days) for a total of three administrations. At week 12, they returned for the end-of-protocol visit (T3). At T0 and T3, patients underwent recording of clinical features, recording of single stimulus (RTh), temporal summation (TST) thresholds of the nociceptive withdrawal reflex, venous blood sampling for miR-382-5p, and miR-34a-5p quantification.

Results

At T3, 31 patients (77.5%) qualified as 30% Responders (reduction in monthly migraine days by at least 30% in the last 4-week observation period). RTh (T0: 15.4 ± 8.1 mA, T3: 19.7 ± 8.2 mA) as well as TST (T0: 11.2 ± 5.8 mA, T3: 13.4 ± 5.0 mA) significantly increased at T3 in 30% Responders (p = 0.001 for both), while we did not observe significant changes in NON-responder patients. MiR-382-5p and miR-34a-5p levels were significantly lower after erenumab administration in the overall study population (p = 0.015, and p = 0.001, respectively), without significant differences between 30% Responder and NON-responder groups.

Conclusions

Different migraine phenotypes, characterized by different treatment susceptibility, may exist as suggested by the divergent behavior between neurophysiological and biomolecular findings in 30% Responder vs. NON-responder patients.

The study protocol was registered at clinicaltrials.gov (NCT04361721).



中文翻译:

erenumab 在慢性偏头痛中的神经生理学和生物分子效应:一项开放标签研究。

介绍

抗降钙素基因相关肽抗体被证明可有效预防慢性偏头痛。在这项开放标签研究中,我们旨在评估 erenumab 给药对慢性偏头痛患者代表性队列中神经生理学和生物分子特征的影响。

方法

40 名在入组前至少有 12 个月的慢性偏头痛病史且之前至少两种不同的预防疗法失败的患者被入组。在 1 个月的观察期 (T0) 后,患者接受 erenumab 70 mg 皮下注射(每 28 天),共给药 3 次。在第 12 周,他们返回进行方案结束访视 (T3)。在 T0 和 T3,患者接受临床特征记录、单一刺激 (RTh) 记录、伤害性撤退反射的时间总和 (TST) 阈值、miR-382-5p 的静脉采血和 miR-34a-5p 量化。

结果

在 T3 时,31 名患者 (77.5%) 符合 30% 的反应率(在过去 4 周的观察期内,每月偏头痛天数减少至少 30%)。RTh(T0:15.4 ± 8.1 mA,T3:19.7 ± 8.2 mA)以及 TST(T0:11.2 ± 5.8 mA,T3:13.4 ± 5.0 mA)在 T3 时在 30% 响应者中显着增加( 两者的p = 0.001) ,而我们没有观察到无反应患者的显着变化。在整个研究人群中,erenumab 给药后 MiR-382-5p 和 miR-34a-5p 水平显着降低(分别为p  = 0.015 和p  = 0.001),30% 响应者和非响应者组之间没有显着差异。

结论

30% 反应者与非反应者患者的神经生理学和生物分子发现之间的不同行为表明,可能存在以不同治疗敏感性为特征的不同偏头痛表型。

该研究方案已在临床试验网站 (clinicaltrials.gov) (NCT04361721) 上注册。

更新日期:2020-07-27
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