NEWS & PERSPECTIVE
Erenumab as a preventive and effective treatment for migraine
Migraine is a neurological disease caused by the release of inflammatory substances in the brain that triggers headache.1 There is an unmet need to develop suitable treatment options for migraine patients with aura.2 Recently, the use of erenumab, the first-in-class anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, has demonstrated significant reduction in migraine frequency and improved safety in patients with migraine.2,3
Migraine is generally classified as episodic (≥4 to <15 migraine days per month and <15 headache days per month) or chronic (≥15 headache days per month, of which ≥8 were migraine days).1 Approximately 10% of the world population suffer from migraine, and nearly one-third of them experience migraine with aura caused by sensory disturbances.2,4 Erenumab, the first-in-class treatment approved by the United States (US) Food and Drug Administration (FDA), targets the migraine-associated CRGP receptor.3 Its efficacy and safety were assessed in migraine patients with aura history. Results of a post-hoc analysis from 4 randomized, double-blind clinical trials indicated that the erenumab treatment decreased the monthly migraine days (MMD) and the usage of acute migraine specific medication (AMSM), regardless of the aura history.2
In these 4 trials, 2,682 patients (aged 18-65 years) from North America, Europe, Russia, and Turkey were randomized to receive a subcutaneous injection of 70mg or 140mg of erenumab (n=1,400) or placebo (n=1,043) once every 4 weeks.2 The subgroups of patients had similar baseline demographic characteristics, with the majority of patients being women (84.1%) and 46.7% of patients (n=1,140) experiencing aura.2 A daily electronic diary was used to report migraine frequency, the use of medication and aura symptoms.2 Erenumab’s potency was tested on both episodic and chronic groups using 70mg or 140mg of erenumab or placebo either with >1 dose during the double-blind treatment (short-term analysis) or >1 dose during the extension periods (long-term analysis).2
Results, compared with placebo, demonstrated that in patients with episodic migraine and aura history treated with 70mg and 140mg of erenumab, the mean changes in MMD at week 12 was reduced by -1.1 days (95% CI: -1.7 to -0.6) and -0.9 days (95% CI: -1.6 to -0.2), respectively. In patients with episodic migraine without aura history treated with 70mg and 140mg of erenumab, MMD was reduced by -1.2 days (95% CI: -1.6 to -0.7) and -2.5 days (95% CI: -3.2 to -1.8), respectively. In patients with chronic migraine and a history of aura, MMD was reduced by -2.1 days with 70mg of erenumab (95% CI: -3.8 to -0.5) and -3.1 days (95% CI: -4.8 to -1.4) with 140mg of erenumab, respectively. In patients with chronic migraine without aura history, MMD was reduced by -2.7 days with 70mg of erenumab (95% CI: -4.1 to -1.3) and -2.1 days with 140mg of erenumab (95% CI: -3.5 to -0.7), respectively.2
Also, patients in the erenumab arm showed significantly lesser usage of acute migraine–specific medication (AMSM) when compared with the placebo arm: Among patients with episodic migraine and aura history, the mean changes in monthly AMSM days when treated with 70mg and 140mg of erenumab were -0.9 (95% CI: -1.4 to -0.3) and -1.3 (95% CI: -2.0 to -0.5), respectively; Among patients with episodic migraine and without aura history, mean changes in monthly AMSM when treated with 70mg and 140mg of erenumab were -1.3 (95% CI: -1.8 to -0.8) and -2.4 (95% CI: -3.1 to -1.8), respectively; Among patients in the chronic group with aura history, the mean changes in AMSM days when treated with 70mg and 140mg of erenumab were -2.4 (95% CI: -3.9 to -1.0) and -3.7 (95% CI: -5.0 to -2.3), respectively; Among patients in the chronic group without aura history, the mean changes in AMSM days when treated with 70mg and 140mg of erenumab were -2.3 (95% CI: -3.5 to -1.0) and -3.0 (95% CI: -4.2 to -1.7), respectively.2 The safety profiles were similar in patients with migraine irrespective of their aura status.2
Overall, erenumab potentially reduces migraine frequency and AMSM days, making it a suitable preventive treatment for migraine patients.2
- Migraine headaches. Available at: https://my.clevelandclinic.org/health/diseases/5005-migraine-headaches. Accessed January 17, 2022.
- Ashina M et al. Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura. JAMA Neurology. 2022.
- King C et al. Discovery of the Migraine Prevention Therapeutic Aimovig (Erenumab), the First FDA-Approved Antibody against a G-Protein-Coupled Receptor. ACS Pharmacology & Translational Science. 2019;2(6):85-490.
- Woldeamanuel Y and Cowan R. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017;15;372:307-315.