Eptinezumab in the treatment of migraine

Intravenous eptinezumab, a peptide antibody that targets calcitonin gene-related peptides, is able to reduce the duration of migraine symptoms. These are, in summary, the results of a recent study published in JAMA, in which the drug was administered to subjects with moderate or severe episodes.

However, the authors specify that the feasibility of intravenous administration of the treatment during a migraine attack remains to be assessed in a targeted manner and that a comparison with alternative treatments will be necessary.

The treatment of migraine

It is estimated that tension-type headache affects about 1.6 billion people worldwide, it is the second most common disorder of all. The second most common type of headache is migraine, a condition that affects about 12% of the general population in Western countries and about 18% of women.

Primary headache disorders have always been treated with various drugs, either for the purpose of treating acute attacks or as preventive therapy, to reduce frequency, intensity and duration of attacks. However, adherence to preventive treatment for migraine appears to be rather poor.

In recent years, many new drugs have been proposed for the treatment of migraine, thanks also to a better understanding of the pathophysiology of this condition. Among the most recent and promising are receptor blockers for the calcitonin gene-related peptides (CGRP) and monoclonal antibodies against the CGRP ligand or its receptor.

However, the progress made in treating migraines with other drugs, such as serotonin receptor agonists, such as triptans, which act by promoting constriction of the great cranial vessels and inhibiting the release of inflammatory neuropeptides from the perivascular nerve terminals of the trigeminal system, should not be forgotten.

Eptinezumab

Eptinezumab, a monoclonal antibody that antagonizes the calcitonin gene-related peptides alpha and beta. It was approved by the FDA in the United States in February 2020. In Europe, its use has not yet been approved by the EMA.

The calcitonin gene-related peptides are part of the calcitonin family of peptides and is present in two forms: alpha and beta.

These peptides are produced in peripheral and central nervous system neurons. It possesses a strong vasodilator effect and intervenes as a mediator in the perception of pain.

In the trigeminal vascular system, the main source of calcitonin gene-related peptides are the cell bodies of the trigeminal ganglion. These peptides also appear to act in the heart, increasing heart rate, probably through a modulation of the autonomic system.

A phase 3 study

This new, phase 3, multicentre, parallel group, double-blind, randomized, placebo-controlled study aimed to evaluate the efficacy and adverse events related to eptinezumab when administered during a migraine attack.

We included subjects with a history of migraine greater than 1 year, with episodes for 4-15 days per month for the previous 3 months. They were treated during a moderate to severe migraine attack with eptinezumab 100 mg or placebo, administered intravenously, within 1-6 hours of symptom onset.

The co-primary efficacy endpoints were the time needed to achieve absence of headache pain and the time to achieve the absence of most symptom associated with pain, such as nausea or photophobia.

Participants had an average age of 44 and 84% were female.

Faster free from pain

Patients treated with eptinezumab achieved pain relief within 4 hours, while those treated with placebo had to wait 9 hours. Even the most frequent associate symptoms resolved more quickly: in 2 hours in the active treatment group and in 3 hours in the control subjects.

At 2 hours after the start of the infusion in the eptinezumab and placebo groups, freedom from headache pain was achieved in 23.5% and 12.0% of cases, respectively. At the same time, the absence of the most associated symptom was achieved in 55.5% and 35.8% of cases, respectively. Significantly fewer eptinezumab-treated patients used rescue medications within 24 hours than placebo-treated patients (31.5% vs 59.9%).

Regarding treatment safety, adverse events occurred in 10.9% of the eptinezumab group and 10.3% of the placebo group. The most common of these was drug hypersensitivity, but no serious adverse events occurred.

Migraine: a new treatment alternative

This new study seems to offer a new therapeutic alternative to the treatment of migraine. However, its main limit is the intravenous route of administration, which certainly does not facilitate its use, especially considering the importance of an early start of treatment.

In this regard, it should be noted that in the United States eptinezumab has been tested and approved as a preventive treatment for migraine, with intravenous administration every three months. On the other hand, the results obtained in this study seem to propose positive effects also in the treatment of acute attacks, reducing the time needed to resolve symptoms.

This post is also available in: Chinese (Simplified)

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