Abstract

Background

One of the advantages of CGRP monoclonal antibodies is their excellent safety and tolerability. However, postmarketing surveillance, is essential to detect potential rare emergent adverse events.

Objectives

To report two patients who developed restless legs syndrome symptoms after treatment with CGRP antibodies.

Methods and results

Two women with chronic refractory migraine, with no significant medical antecedents, developed typical restless legs syndrome symptoms 1.5 and 4 months after starting erenumab 140 mg, respectively. In case 1 symptoms resolved when erenumab was stopped for two months but reappeared on galcanezumab. In both patients migraine attacks had dramatically decreased and no iron deficiency was found.

Conclusions

Even though caution is needed before establishing a causal relationship, these cases suggest that restless legs-like symptoms might be an emergent adverse event of CGRP antibodies, regardless of the mechanism of action. We propose that plastic changes in CGRP sensory fibers, which are very abundant in legs, induced by CGRP monoclonal antibodies could be the reason for restless legs syndrome development.

中文翻译：

---

不宁腿样综合征作为 CGRP 单克隆抗体的紧急不良事件：附 2 例报告

摘要

背景

CGRP单克隆抗体的优点之一是其出色的安全性和耐受性。然而，上市后监测对于检测潜在的罕见紧急不良事件至关重要。

目标

报告两名患者在接受 CGRP 抗体治疗后出现不宁腿综合征症状。

方法和结果

两名患有慢性难治性偏头痛的女性，没有明显的医学前因，分别在开始使用 140 mg erenumab 后 1.5 和 4 个月出现了典型的不宁腿综合征症状。如果 erenumab 停药两个月后症状 1 消失，但在 galcanezumab 上再次出现。在这两名患者中，偏头痛发作都显着减少，并且没有发现缺铁。

结论

尽管在建立因果关系之前需要谨慎，但这些病例表明，不宁腿样症状可能是 CGRP 抗体的紧急不良事件，无论作用机制如何。我们提出，由 CGRP 单克隆抗体诱导的 CGRP 感觉纤维在腿部非常丰富的塑性变化可能是不宁腿综合征发展的原因。