Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures: subgroup analysis of the randomized, placebo-controlled DELIVER study
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Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures : subgroup analysis of the randomized, placebo-controlled DELIVER study. / Ashina, Messoud; Lanteri-Minet, Michel; Ettrup, Anders; Christoffersen, Cecilie Laurberg; Josiassen, Mette Krog; Phul, Ravinder; Sperling, Bjørn; Pozo-Rosich, Patricia.
I: Cephalalgia, Bind 43, Nr. 5, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures
T2 - subgroup analysis of the randomized, placebo-controlled DELIVER study
AU - Ashina, Messoud
AU - Lanteri-Minet, Michel
AU - Ettrup, Anders
AU - Christoffersen, Cecilie Laurberg
AU - Josiassen, Mette Krog
AU - Phul, Ravinder
AU - Sperling, Bjørn
AU - Pozo-Rosich, Patricia
N1 - Funding Information: The authors thank Mary Tom, PharmD, and Nicole Coolbaugh, CMPP, of The Medicine Group (New Hope, PA, USA), for providing medical writing support in accordance with Good Publication Practice guidelines, which was funded by H. Lundbeck A/S. Funding Information: The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was sponsored and funded by H. Lundbeck A/S, including medical writing support for the development of the manuscript. In collaboration with the academic authors, the sponsor participated in the design and conduct of the study and in the collection, management, analysis, and interpretation of the data. The preparation, review, and approval of the manuscript was undertaken by all authors and by a professional medical writer and editor funded by the sponsor. All authors and H. Lundbeck A/S prepared, reviewed, and approved the final version of the manuscript and made the decision to submit the manuscript for publication. The sponsor did not have the right to veto publication or to control the decision regarding to which journal the manuscript was submitted. Publisher Copyright: © International Headache Society 2023.
PY - 2023
Y1 - 2023
N2 - Background: Migraine is a disabling neurological disease adversely affecting many aspects of life. Most patients are still required to have failed several older oral preventive therapies before being reimbursed for a preventive, migraine-specific anti-calcitonin gene-related peptide treatment. In the 24-week placebo-controlled portion of DELIVER, eptinezumab was shown to reduce migraine frequency and resulted in higher migraine responder rates compared with placebo in patients with two to four previous preventive treatment failures. This subgroup analysis assessed if demographic or clinical characteristics were associated with differences in preventive benefits. Methods: Migraine frequency reductions and responder rates (i.e., the proportion of patients reaching a ≥50% and ≥75% reduction in monthly migraine days relative to baseline) were determined in the total population and predefined subgroups by sex, age, migraine frequency (chronic migraine, episodic migraine, high-frequency episodic migraine, low-frequency episodic migraine), medication overuse, medication-overuse headache, and previous preventive treatment failures (2, >2). The primary endpoint was change from baseline in monthly migraine days over weeks 1–12. Results: Eptinezumab 100 and 300 mg reduced monthly migraine days more than placebo over weeks 1–12 (−4.8 and −5.3 vs –2.1, respectively; p < 0.0001). In most subgroups, eptinezumab-treated patients demonstrated larger monthly migraine days reductions from baseline over weeks 1–12 than patients receiving placebo, with reductions maintained or increased over weeks 13–24. For ≥50% and ≥75% migraine responder rates, the odds ratios versus placebo all numerically favored eptinezumab. Conclusion: Eptinezumab had larger monthly migraine days reductions and higher responder rates than placebo across clinically relevant subgroups showing that, across different demographic populations and clinical characteristics, eptinezumab is effective in patients with migraine and prior preventive treatment failures. Trial Registration: ClinicalTrials.gov (Identifier: NCT04418765)
AB - Background: Migraine is a disabling neurological disease adversely affecting many aspects of life. Most patients are still required to have failed several older oral preventive therapies before being reimbursed for a preventive, migraine-specific anti-calcitonin gene-related peptide treatment. In the 24-week placebo-controlled portion of DELIVER, eptinezumab was shown to reduce migraine frequency and resulted in higher migraine responder rates compared with placebo in patients with two to four previous preventive treatment failures. This subgroup analysis assessed if demographic or clinical characteristics were associated with differences in preventive benefits. Methods: Migraine frequency reductions and responder rates (i.e., the proportion of patients reaching a ≥50% and ≥75% reduction in monthly migraine days relative to baseline) were determined in the total population and predefined subgroups by sex, age, migraine frequency (chronic migraine, episodic migraine, high-frequency episodic migraine, low-frequency episodic migraine), medication overuse, medication-overuse headache, and previous preventive treatment failures (2, >2). The primary endpoint was change from baseline in monthly migraine days over weeks 1–12. Results: Eptinezumab 100 and 300 mg reduced monthly migraine days more than placebo over weeks 1–12 (−4.8 and −5.3 vs –2.1, respectively; p < 0.0001). In most subgroups, eptinezumab-treated patients demonstrated larger monthly migraine days reductions from baseline over weeks 1–12 than patients receiving placebo, with reductions maintained or increased over weeks 13–24. For ≥50% and ≥75% migraine responder rates, the odds ratios versus placebo all numerically favored eptinezumab. Conclusion: Eptinezumab had larger monthly migraine days reductions and higher responder rates than placebo across clinically relevant subgroups showing that, across different demographic populations and clinical characteristics, eptinezumab is effective in patients with migraine and prior preventive treatment failures. Trial Registration: ClinicalTrials.gov (Identifier: NCT04418765)
KW - Chronic migraine
KW - efficacy
KW - episodic migraine
KW - eptinezumab
U2 - 10.1177/03331024231170807
DO - 10.1177/03331024231170807
M3 - Journal article
C2 - 37125484
AN - SCOPUS:85156260774
VL - 43
JO - Cephalalgia
JF - Cephalalgia
SN - 0800-1952
IS - 5
ER -
ID: 397033749