Abstract
Migraine is the second cause of disability and of lost years of healthy life worldwide. Migraine is characterized by recurrent headache attacks and accompanying disabling symptoms lasting 4–48 h. In episodic migraine, attacks occur in less than 15 days per month and in chronic migraine, in more than 15 monthly days. Whilst successful translation of pharmacological discoveries into efficacious therapeutics has been achieved in the preventative therapy of chronic migraine, treatment of acute migraine suffers the lack of effective advancements. An effective treatment affords complete freedom from pain two hours after therapy and provides the absence of the most bothersome symptom (MBS) associated with migraine after 2 h. However, available anti-migraine abortive treatments for acute attacks do not represent an effective and safe treatment for all the populations treated. In particular, the most used specific treatment is represented by triptans that offer 2-h sustained freedom from pain achieved in 18–50% of patients but they are contraindicated in coronary artery disease, stroke and peripheral vascular disease due to the vasoconstriction at the basis of their pharmacologic action. The most novel therapies, i.e., gepants and ditans, are without sufficient post-marketing data for secure use. Here, an attempt is proposed to analyse the rational basis and evidence in favour of investigating the efficacy and safety in acute migraine attacks of eptinezumab, i.e., monoclonal antibody (mAb) directed towards calcitonin gene-related peptide (CGRP) unique for intravenous infusion administration.
Highlights
Some 716.8 million people aged 15–49 years are affected by migraine which is the second cause of disability and of lost years of healthy life worldwide and the first within the female population [1]
ALD403 Safety and Efficacy 1 (PROMISE-1) (NCT02559895) clinical trial [61] has demonstrated the significant effectiveness of the intravenous administration of eptinezumab with a higher number of patients with a ≥50% or ≥75% reduction of episodic migraine compared to the placebo during one year of treatment, in which it was well tolerated
The phase 3, multicentre, parallel-group, double-blind, randomized, placebo-controlled trial NCT04152083 [69] has assessed the efficacy of the infusion of eptinezumab during an active migraine attack in patients eligible for preventive migraine treatment based on International Classification of Headache Disorders 3rd edition (ICHD-3) criteria: the co-primary endpoints were time to headache pain freedom and time to absence of most bothersome symptom (MBS), both expressed as median time
Summary
Some 716.8 million people aged 15–49 years are affected by migraine which is the second cause of disability and of lost years of healthy life worldwide and the first within the female population [1]. The International Classification of Headache Disorders 3rd edition (ICHD-3) defines migraine as a primary headache disorder characterized by episodes which can occur with (in 1/3 of cases) or without aura, usually preceded of hours or days (premonitory phase) or associated with transient focal neurological symptoms (visual, sensory, language and brainstem disturbances) [2]. Some of these symptoms due to altered balance between sympathetic and parasympathetic systems can last over the attack to the postdromal phase [3].
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