Abstract

BackgroundClinical trials have shown the safety and clinical superiority of erenumab compared to placebo in chronic migraine (CM). The aim of this analysis is to evaluate the effectiveness and tolerability of erenumab in a real-world setting in patients with refractory CM.MethodsThis is a prospective single centre real-world audit conducted in patients with CM with and without medication overuse, refractory to established preventive medications, who received monthly erenumab for 6 months.ResultsOf 164 patients treated, 162 patients (female = 135, mean age 46 ± 14.3 years old) were included in the audit. Patients had failed a mean of 8.4 preventive treatments at baseline and 91% of patients failed Botulinum toxin type A at baseline. The mean reduction in monthly migraine days was 6.0 days at month 3 (P = 0.002) and 7.5 days at month 6 (P < 0.001) compared to baseline. The mean reduction in monthly headache days was 6.3 days (P < 0.001) at month 3 and 6.8 days (P < 0.001) at month 6. At month 3, 49%, 35% and 13% and at month 6, 60%, 38% and 22% of patients obtained at least a 30%, 50% and 75% reduction in migraine days, respectively. The percentage of patients with medication overuse was reduced from 54% at baseline to 20% at month 3 and to 25% at month 6. Compared to baseline, the mean reduction of Headache Impact Test-6 score was 7.7 points at month 3 (from 67.6 ± 0.4 to 59.9 ± 0.9) (P < 0.001) and of 7.5 points at month 6 (60.1 ± 1.3) (P = 0.01). The percentage of patients with severe headache-related disability (HIT-6: 60–78) was reduced from 96% at baseline to 68% after three monthly treatments and to 59% after six treatments. At least one side effect was reported by 48% of patients at month 1, 22% at month 3 and 15% at month 6. Constipation (20%) and cold/flu-like symptoms (15%) were the most frequent adverse events reported.ConclusionErenumab may be an effective and well tolerated therapy for medically refractory CM patients with and without medication overuse.

Highlights

  • Chronic migraine affects 1.4–2.2% of the general population with an annual incidence among episodic migraine people of 2.5% [1, 2]

  • Completed headache diaries and Headache Impact Test6 (HIT-6) for all months, were obtained by 162 patients [135 female; mean age 46 Standard Deviation (SD) ± 14 years] who were included in the analysis

  • All patients were medically refractory according to the European headache federation (EHF) consensus [5], with the average number of failed preventive treatments being 8.4 ± 3.6

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Summary

Introduction

Chronic migraine affects 1.4–2.2% of the general population with an annual incidence among episodic migraine people of 2.5% [1, 2]. A recent consensus of the European Headache Federation (EHF) has proposed a distinction of the difficult-to-treat migraine patients into resistant, for those who fail to respond or tolerate three drug classes with established evidence in migraine; and refractory, for those patients who fail all drug classes with established evidence in migraine [7] This group of patients suffers with severe disruption of their quality of life and the refractoriness of their symptoms contributes to high degree of healthcare resources utilization [8, 9]. Clinical trials have shown the safety and clinical superiority of erenumab compared to placebo in chronic migraine (CM)

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