The primary and key secondary results on Vyepti® (eptinezumab) from the DELIVER study in patients with migraine and prior preventive treatment failures are now published in the high-impact medical journal Lancet Neurology.
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"We are incredibly proud that our clinical research is recognized by the medical and scientific community. The publication of the DELIVER results by Lancet Neurology is a clear indication that Lundbeck performs clinical research of the highest quality, and that the results of these efforts are relevant to both clinicians and patients."
The DELIVER study investigated the efficacy and safety of Vyepti 100 mg and 300 mg IV infusion in patients with chronic or episodic migraine who had experienced 2-4 previous preventive treatment failures due to lack of efficacy or intolerable side effects. The DELIVER study met its primary objective of demonstrating statistically significant superiority of Vyepti versus placebo in reducing the number of monthly migraine days (MMDs) over 12 weeks of treatment and it also achieved statistical significance on all key secondary outcome measures.
"These results contribute to the expanding body of evidence in support of migraine preventive treatments with anti-CGRP monoclonal antibodies in patients with previous preventive treatment failures to traditional oral medication. The key message from the study results, which is relevant for both physicians and patients, is that even after multiple treatment failures, there is still hope that patients can respond to this new class of anti-CGRP treatments", says, Dr. Messoud Ashina, Professor of Neurology, and lead author on the DELIVER publication.
While 42% to 49% of patients who received Vyepti in the DELIVER study achieved a ≥50% reduction in MMDs over 12 weeks, other studies with subcutaneously administered monoclonal antibodies targeting CGRP or its receptor (erenumab, fremanezumab, and galcanezumab) in patients with migraine and 2-4 previous preventive treatment failures migraine report that 30-38% of patients achieved a ≥50% reduction in MMDs[i],[ii],[iii]. In addition to the reduction in frequency of migraine days for patients treated with Vyepti, a larger reduction in the percentage of severe attacks for the remaining headache episodes compared to placebo was observed.
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About the DELIVER study
DELIVER (NCT04418765) is a phase lllb, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Vyepti in patients with chronic or episodic migraine. Chronic migraine was defined as migraine occurring on ≥8 days per month and headache occurring on >14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes. Patients who experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians´ confirmation specific to each treatment in the past 10 years.
In the study, 892 patients were randomized to receive eptinezumab 100mg or 300mg or placebo by intravenous (IV) infusion. Patients included in the study most frequently experienced treatment failures of topiramate and amitriptyline, with 550(61.8%), 277(31.1%), and 60(6.7%) patients experiencing 2, 3, and 4 prior preventive treatment failures respectively. The primary endpoint was change from baseline in the number of monthly migraine days over Weeks 1-12. Key secondary endpoints included response rates as patients with 50% or greater reduction from baseline in MMDs (Weeks 1-12), response rates of patients with 75% or greater reduction from baseline in MMDs (Weeks 1-12) and change from baseline in the number of MMDs (Weeks 13-24). Other secondary endpoints assessed the effect of Vyepti vs placebo on: 6-item Headache Impact test score (HIT-6), Migraine-specific quality of life (MSQ v2.1), HRQoL (EQ-5D-5L) visual analogue scale (VAS) score, Health care resources utilization (HCRU), and Work Productivity and Activity Impairment Questionnaire (WPAI).
About Vyepti® (eptinezumab)
Vyepti is a humanized monoclonal antibody that binds to CGRP which was purposefully developed for IV administration. The efficacy and safety of Vyepti was evaluated in two phase III clinical trials (PROMISE-1 in episodic migraine[iv] and PROMISE-2 in chronic migraine[v]), where Vyepti met its primary endpoint of decrease in MMDs over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program demonstrated a treatment benefit over placebo that was observed for both doses of Vyepti as early as day 1 post-infusion. For the initial approval, the safety of Vyepti was evaluated in 2,076 adult patients with migraine who received at least one dose of Vyepti. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with Vyepti discontinued treatment due to adverse reactions.
Vyepti® (eptinezumab-jjmr) was approved by the
About migraine
Migraine is a complex and incapacitating neurological disease characterized by recurrent episodes of severe headaches typically accompanied by an array of symptoms, including nausea, vomiting, and sensitivity to light or sound[vi]. It is estimated to affect approximately 39 million people in the
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References
[i] Reuter U, et al.
[ii] Ferrari MD, et al.
[iii] Mulleners WM, et al. Lancet Neurol. 2020;19:814-825.
[iv] Ashina M, et al. Cephalalgia. 2020 Mar;40(3):241-254
[v] Lipton RB, et al. Neurology. 2020 Mar 31;94(13):e1365-e1377
[vi] Villalón CM. Pharmacol Ther. 2009;124(3):309-323
[vii] Steiner TJ, et al. J Headache Pain. 2018;19(1):17.
[viii] Gustavsson A, et al. 2011 Oct;21(10):718-79.
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