Eptinezumab: A calcitonin gene-related peptide monoclonal antibody infusion for migraine prevention

Abstract

This article seeks to analyze the clinical trials concerning the newly approved eptinezumab to assess its efficacy, safety, and application to current clinical practice. The Institute of Health US National Library of Medicine Clinical Trials, PubMed, and Cochrane Library databases were searched for relevant abstracts, journal articles, and other published sources. Search terms included eptinezumab, Vyepti®, and ALD403. Relevant English-language articles were evaluated and included in the narrative. Two randomized controlled trials compared quarterly infusions of eptinezumab 100 mg, eptinezumab 300 mg, and placebo in chronic and episodic migraine sufferers. In episodic migraine, eptinezumab resulted in a reduction of approximately 4 monthly migraine days, which was significant compared to placebo. In chronic migraine, eptinezumab reduced monthly migraine days by approximately 8 days, also significant compared to placebo. More patients who received eptinezumab experienced at least 75% reduction in monthly migraine days compared to placebo, resulting in a number needed to treat as low as 6, depending on the study population and the dose. The preventive impact was noticed day one post-infusion. The most common treatment-emergent adverse events were nausea and fatigue, and there was a low incidence of hypersensitivity or study withdrawal. Eptinezumab is the fourth Calcitonin Gene-related Peptide monoclonal antibody to receive Federal Drug Administration approval. Its delivery as a quarterly infusion sets it apart from the other agents in this class. As an infusion, eptinezumab has a quick onset of action that may prove especially beneficial to those with severe or refractory episodic or chronic migraines, despite the perceived increased direct and indirect cost of an infusion.

Efficacy and safety of eptinezumab as migraine preventive therapy: A systematic review and meta-analysis

“…The recommended dose of eptinezumab is 100 mg or 300 mg every 3 months. Some patients require a dose of 300 mg. Eptinezumab is given intravenously in 100 ml of a 0.9% NaCl solution for 30 minutes, so its administration requires professional healthcare (Morgan and Joyner 2021).…”

Recent advances in the pharmacological treatment of chronic pain: a systematic review

“…Treatment with galcanezumab was only not effective in ameliorating pain in patients suffering from chronic cluster headaches 152 . The anti-CGRP antibodies included in the present study were administrated subcutaneously, and pain and discomfort at the injection site were the most common adverse event [153][154][155][156] .…”

Eptinezumab for the preventive treatment of episodic and chronic migraine: a narrative review

“…Eptinezumab is the only antibody targeting the CGRP pathway with an intravenous route of administration. Pharmacokinetic analyses (46) showed that the maximum concentration (C max ) was immediate (i.e., 30 min after the start of a 30-min administration), which might provide an explanation for the fast onset of eptinezumab effect (46,47), and contrasts with longer median values (4-14 days) of subcutaneous (SC) anti-CGRP (48)(49)(50). The eptinezumab elimination half-life of 27 days and the low exposure metrics required to achieve 90% of the maximal efficacy (EC 90 ) supports its administration every 12 weeks.…”

“…In terms of route of administration, IV infusions have shown higher C max than SC and intramuscular administrations (47). The rapid attainment of high plasma concentrations with the IV administration together with the good tolerability (even when co-administered with SC sumatriptan) and low immunogenicity, supported the administration of eptinezumab as IV infusions (47).…”