Abstract
We present a review of the efficacy and safety profile of eptinezumab (also known by the brand name Vyepti), a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) developed by Lundbeck Seattle BioPharmaceuticals, Inc., that received its first approval in the USA on 21 February 2020 for the preventive treatment of migraine in adults. It is administered by an intravenous infusion at a 100 mg dose every 3 months and shows no drug interactions.Studies have shown that eptinezumab is an effective preventative medication in migraine which starts showing its effect from day 1 of its administration, which maintains a consistent level of efficacy through a year of its treatment at doses 100 mg and 300 mg. It was found to be effective at reducing time to headache pain freedom during acute migraine attacks as well.Eptinezumab is a relatively safe drug for the prevention of migraines with treatment-related adverse events occurring at a low frequency. They bear a safe profile in patients with comorbidities like obesity and type 1 diabetes. The most frequent adverse events observed were nasopharyngitis, upper respiratory tract infections (URTIs), and sinusitis and were usually mild. The development of anti-drug antibodies was common, but they declined to undetectable levels with continued dosing and did not appear to impact the overall safety profile of the drug. Further studies are needed to assess long-term safety, use in different patient populations, and to compare its efficacy to other drugs of its class.
Highlights
BackgroundAccording to the International Classification of Headache Disorders, migraine is defined as a recurrent headache disorder manifesting in attacks lasting 4-72 hours [1]
NCT04537429 is a clinical trial with 32 participants aged 6-17 years to evaluate the pharmacokinetic properties of eptinezumab in this age group, with a secondary aim to track the development of anti-eptinezumab antibodies [35]
We looked at the efficacy and safety profile of eptinezumab, a new calcitonin gene-related peptide (CGRP) monoclonal antibody developed for the treatment of migraines
Summary
According to the International Classification of Headache Disorders, migraine is defined as a recurrent headache disorder manifesting in attacks lasting 4-72 hours [1]. Similar results were reported in the PROMISE-2 (NCT02974153) study, a randomized, double-blind, multicentre, placebo-controlled trial that involved 1072 adults with chronic migraine [19] These patients were divided into three groups: eptinezumab 100 mg (n=356) or 300 mg (n=350) or placebo (n=366) every 3 months for 6 months; and they were allowed to take other migraine preventatives (except onabotulinumtoxinA). Subsequent post hoc analysis of the PROMISE-2 trial revealed that within the first 4 weeks itself, eptinezumab 100 or 300 mg increased the number of days free from typical migraine symptoms such as nausea, vomiting, and photophobia; improved ratings on the patient-reported patient global impression of change (PGIC) scale (45% and 59% vs 32%), and significantly reduced the functional impact of headache (assessed by the six-item Headache Impact Test or HIT-6 total score) with this benefit sustained even at 24 weeks [21] This benefit was seen even in the subgroup of patients in PROMISE-2 who very often or always experienced severe pain during headaches [22]. A summary of the various trials with adverse effects has been illustrated in Table 1 [17, 19, 29, 30]
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