Background

We aimed to systematically assess the effectiveness and tolerability of erenumab in a clinical setting, specifically a tertiary headache center.

Methods

This was a retrospective cohort study at the John Graham Headache Center of Brigham and Women’s Hospital. All patients who received erenumab from a headache specialist at the Center from 17 May 2018 to 31 January 2019 were included. Patients were contacted and underwent a structured clinical interview including information about erenumab use, perceived benefit, adverse events (AEs), and a global assessment of benefit versus drawbacks. Chart review was performed for patients who could not be contacted.

Results

Four hundred and forty-four patients were initially identified and 418 were eligible. Two hundred and ninety-five participants completed the structured clinical interview portion of the study (response rate 70.6%). Seventy-four patient charts were additionally reviewed. Two hundred and forty-one participants had used erenumab. One hundred and sixty nine (70%) of participants experienced at least one adverse event, with constipation (43%), injection site reaction (24%), fatigue (15%), worsening headache (12%), and dizziness (11%) the five most commonly reported AEs. One hundred and sixty-eight participants (69.7%) felt that the benefits of erenumab outweighed any drawbacks. One hundred and fifty-one participants (62.7%) planned to continue using erenumab. Cost of treatment was cited by 12% of participants as a reason for either not starting or for stopping erenumab. Of patients who had an increase in dose due to lack of or partial efficacy, 46.5% felt that the dose increase was helpful. We identified one case of unintended pregnancy in our study population.

Conclusions

This large “real-world” study validates the findings of benefit of erenumab observed in clinical trials. Although adverse events were far more common in this population than in clinical trials, the planned continuation rate was relatively high. The substantial discrepancy between adverse events seen in clinical practice compared with clinical trials suggests systematic differences between clinical trial participants and patients who receive the treatment in clinical practice, or may indicate suboptimal ascertainment of adverse events in the trials. Clinicians should continue to be vigilant for adverse events in clinical practice.

中文翻译：

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erenumab 的真实世界有效性和耐受性：一项回顾性队列研究。

背景

我们旨在系统地评估 erenumab 在临床环境中的有效性和耐受性，特别是三级头痛中心。

方法

这是在布莱根妇女医院的约翰格雷厄姆头痛中心进行的一项回顾性队列研究。包括在 2018 年 5 月 17 日至 2019 年 1 月 31 日期间从该中心的头痛专家处接受 erenumab 治疗的所有患者。联系了患者并接受了结构化的临床访谈，包括有关 erenumab 使用、感知益处、不良事件 (AE) 以及益处与缺点的整体评估的信息。对无法联系到的患者进行了图表审查。

结果

最初确定了 444 名患者，418 名符合条件。295 名参与者完成了研究的结构化临床访谈部分（响应率 70.6%）。此外还审查了 74 个患者图表。241 名参与者使用过 erenumab。一百六十九 (70%) 名参与者至少经历过一次不良事件，包括便秘 (43%)、注射部位反应 (24%)、疲劳 (15%)、头痛恶化 (12%) 和头晕 (11) %) 五个最常报告的 AE。168 名参与者 (69.7%) 认为 erenumab 的好处超过了任何缺点。151 名参与者 (62.7%) 计划继续使用 erenumab。12% 的参与者将治疗费用列为不开始或停止使用 erenumab 的原因。在因缺乏或部分疗效而增加剂量的患者中，46.5% 的患者认为增加剂量是有帮助的。我们在我们的研究人群中发现了一例意外怀孕。

结论

这项大型“真实世界”研究验证了在临床试验中观察到的 erenumab 益处的发现。尽管该人群中的不良事件远比临床试验中常见，但计划的继续使用率相对较高。与临床试验相比，临床实践中观察到的不良事件之间的巨大差异表明临床试验参与者和在临床实践中接受治疗的患者之间存在系统差异，或者可能表明试验中不良事件的确定不理想。临床医生应继续警惕临床实践中的不良事件。