Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication‐overuse headache: Subgroup analysis of PROMISE‐2

Diener, Hans Christoph; Marmura, Michael J.; Tepper, Stewart J.; Cowan, Robert P.; Starling, Amaal J.; Diamond, Merle L.; Hirman, Joe; Mehta, Lahar; Brevig, Thomas; Sperling, Bjørn; Cady, Roger

doi:10.1111/head.14036

Cited by 63 publications

(91 citation statements)

References 31 publications

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Section: Discussionmentioning

confidence: 95%

“…Eptinezumab treatment was also associated with a large reduction in the percentage of patients overusing AHM, as well as a numerically greater percentage of patients transitioning from CM to episodic migraine compared with placebo. In total, 50.5% of those patients treated with eptinezumab 100 mg and 49.5% of those treated with eptinezumab 300 mg were consistently below MOH diagnostic thresholds for AHM use for the entirety of the 24-week treatment period compared with 27.1% of patients who received placebo 17. More than one-fourth (29.0%) of patients treated with eptinezumab and 6.3% of patients who received placebo demonstrated resolution of both diagnoses, experiencing 24 weeks without overusing AHM per MOH diagnostic thresholds and without experiencing CM diagnostic thresholds for headache and migraine days.…”

mentioning

confidence: 92%

“…A population pharmacokinetic analysis using data from eight trials of eptinezumab found that patient characteristics (including demographics and disease state) had no clinically significant effects on pharmacokinetic parameters, concluding that no dose adjustments were necessary in different patient populations 11 . A post hoc analysis of the PROMISE‐2 trial found that, in patients with a dual diagnosis of CM and MOH, eptinezumab showed migraine‐preventive efficacy on the primary and key secondary endpoints compared with placebo 17 …”

Section: Introductionmentioning

confidence: 99%

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Preventive migraine treatment with eptinezumab reduced acute headache medication and headache frequency to below diagnostic thresholds in patients with chronic migraine and medication‐overuse headache

et al. 2021

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Objective: This post hoc analysis in patients medically diagnosed with chronic migraine (CM) and medication-overuse headache (MOH) evaluated reductions in the use of acute headache medication (AHM) and sustained changes in the diagnostic status of CM and MOH following eptinezumab treatment in the PROMISE-2 study.Background: Eptinezumab, a monoclonal antibody that inhibits calcitonin generelated peptide, is approved in the United States for the preventive treatment of migraine. A previous analysis showed that eptinezumab reduced monthly migraine days and was well tolerated in the subgroup of PROMISE-2 patients diagnosed with both CM and MOH. Methods:The phase 3, double-blind, placebo-controlled PROMISE-2 study (NCT02974153) randomized adults with CM to eptinezumab 100 mg, 300 mg, or placebo (administered intravenously every 12 weeks for up to two doses). MOH was prospectively diagnosed at screening by trained physicians based on 3 months of medication history and International Classification of Headache Disorders-3β criteria. This post hoc analysis evaluated changes in total and class-specific days of AHM usage, the percentage of patients using AHM at or above MOH diagnostic thresholds, and the percentage of patients experiencing monthly headache and migraine day frequency below diagnostic thresholds for MOH and/or CM. Results:In PROMISE-2, 431/1072 (40.2%) patients with CM were diagnosed with MOH (eptinezumab 100 mg, n = 139; 300 mg, n = 147; placebo, n = 145) and were

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Section: Discussionmentioning

confidence: 95%

mentioning

confidence: 92%

Section: Introductionmentioning

confidence: 99%

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Preventive migraine treatment with eptinezumab reduced acute headache medication and headache frequency to below diagnostic thresholds in patients with chronic migraine and medication‐overuse headache

et al. 2021

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“…26 In a subgroup analysis of patients enrolled in PROMISE-2 with a dual diagnosis of medication overuse headache, eptinezumab demonstrated consistent improvement in monthly migraine days compared to placebo over weeks 1–12 (−8.4 days for 100 mg, −3.0 difference from placebo, 95% confidence interval (CI) = −4.56 to −1.52; −8.6 days for 300 mg, −3.2 difference from placebo, 95% CI = −4.66 to −1.78; −5.4 days for placebo) and weeks 13–24 (−9.2 days for 100 mg, −3.4 difference from placebo, 95% CI = −5.03 to −1.85; −9.2 days for 300 mg, −3.4 difference from placebo, 95% CI = −4.99 to −1.87; −5.8 days for placebo). 27 This may further demonstrate that eptinezumab is similarly useful in patients with medication overuse headaches.…”

Section: Bodymentioning

confidence: 91%

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

Morgan

Joyner

2021

SAGE Open Medicine

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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.

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“…Diener et al conducted another subgroup analysis of the PROMISE-2 trial to evaluate eptinezumab 100 mg and 300 mg in patients having both diagnoses of chronic migraine (CM) and medication-overuse headache (MOH) [25]. They found that eptinezumab treatment resulted in greater reductions in MMDs, higher responder rates, and fewer patients meeting CM and MOH criteria post-treatment, thus highlighting the efficacy of eptinezumab in this patient population.…”

Section: Phase 3 Trials -Promise-1 and Promise-2mentioning

confidence: 99%

A Review of Eptinezumab Use in Migraine

Datta¹,

Maryala

John³

2021

Cureus

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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.

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Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication‐overuse headache: Subgroup analysis of PROMISE‐2

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 63 publications

References 31 publications

Preventive migraine treatment with eptinezumab reduced acute headache medication and headache frequency to below diagnostic thresholds in patients with chronic migraine and medication‐overuse headache

Preventive migraine treatment with eptinezumab reduced acute headache medication and headache frequency to below diagnostic thresholds in patients with chronic migraine and medication‐overuse headache

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

A Review of Eptinezumab Use in Migraine

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