The effect of calcitonin gene-related peptide monoclonal antibodies on restless legs syndrome in patients with migraine.

Abstract

Background: Calcitonin gene-related peptide monoclonal antibody (CGRP mAb) effects on restless legs syndrome (RLS) are unclear.

Methods: Fifteen migraine patients (aged 49.1 ± 5.8 years; 14 women) with concomitant RLS who received CGRP mAbs (2 erenumab, 3 galcanezumab, and 10 fremanezumab) were retrospectively studied. Number of monthly migraine days (MMDs) was obtained from headache diaries. The primary outcome is changes in RLS severity as assessed by the International RLS Group Rating Scale (IRLS). Headache-related disability was assessed using the Migraine Disability Assessment (MIDAS). The severity of headache and RLS was rated using the Patient Global Impression of Change (PGIC) scale. Central sensitization was evaluated with the Central Sensitization Inventory (CSI).

Results: At 1, 2, and 3 months, the percentages of patients with ≥ 50% improvement in number of MMDs were 53.3%, 66.6%, and 60.0%, respectively. From baseline to 3 months, there were significant reductions in the MIDAS (25.1 ± 23.2 vs. 19.7 ± 22.8, p = 0.005) and CSI scores (36.3 ± 12.9 vs. 29.1 ± 12.3, p = 0.001). IRLS scores decreased significantly from baseline to 1 month (-8.8 ± 2.1 points) and 3 months (-11.6 ± 2.3 points) after CGRP mAb treatment. On the PGIC scale, 86.7% and 73.3% of patients reported at least "minimal improvement" in migraine and RLS severity, respectively, with 46.7% and 26.7% reporting "very much improvement". Among those with a < 50% reduction in number of MMDs at 3 months, 66.6% reported at least "minimal improvement", with 33.3% reporting "very much improvement".

Conclusion: Our study revealed that 3-month CGRP mAb treatment significantly alleviated RLS symptoms, central sensitization and headache-related disability in patients with comorbid migraine and RLS.