A prospective real-world analysis of erenumab in refractory chronic migraine

Abstract

Background: Clinical 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.

Methods: This 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.

Results: Of 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.

Conclusion: Erenumab may be an effective and well tolerated therapy for medically refractory CM patients with and without medication overuse.

Keywords: CGRP; Chronic migraine; Erenumab; Monoclonal antibodies; Refractory migraine.

Conflict of interest statement

G.L. has received speaker honoraria, funding for travel and has received honoraria for participation in advisory boards sponsored by Allergan, Novartis, Eli Lilly and TEVA. He has received speaker honoraria, funding for travel from electroCore, Nevro Corp. and Autonomic Technologies. B.H. reports no disclosure. M.M. reports no disclosure. I.T. reports no disclosure. A.P.A received speaker honoraria and funding for travel from Allergan, Eli Lilly and eNeura, honoraria for participation in advisory boards sponsored by Allergan and Eli Lilly, sponsorship for educational purposes from eNeura, Allergan, Autonomic Technologies and Novartis, and an equipment grant from eNeura.

Figures

Fig. 1

Audit design: Chronic migraine patients who failed at least 3 preventive treatments, with or without medication overused, were offered monthly subcutaneous injections of erenumab at 70 mg for 3 months. At the three-month time point, patients who achieved at least a 50% reduction in migraine days, were offered the option to continue their treatment with monthly injections of erenumab at 70 mg. Patients who achieved less than 50% reduction in their migraine days, were offered the option to receive monthly injections of erenumab at 140 mg for the next three consecutive months. Any patient who achieved less than 30% reduction in their migraine days at the six-month time point discontinued the erenumab treatment, while patients who achieved at least 30% reduction in their migraine days continue the erenumab treatment at 140 mg

Fig. 2

Six-month outcomes on all patients treated with erenumab: Overall, during the entire six month observation period post-erenumab treatment initiation, monthly migraine days (MMD), headache days (MHD), days of abortive use and headache impact test (HIT-6) were significantly reduced compared to baseline (mean ± st. er.)

Fig. 3

Monthly responders rates: Percentage of patients who achieved at least a 30%, 50% or 75% reduction in monthly migraine days per month, post-erenumab treatment initiation

Fig. 4

Percentage of chronic and episodic migraine patients: Percentage of patients who converted into an episodic migraine pattern (