Patient-reported migraine-specific quality of life, activity impairment and headache impact with once-daily atogepant for preventive treatment of migraine in a randomized, 52-week trial
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Background: Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist for the preventive treatment of episodic migraine. Methods: In this 52-week, multicenter, randomized, open-label trial, adults with 4–14 monthly migraine days received atogepant 60 mg once-daily or standard care. Health outcome endpoints collected from participants randomized to atogepant included change from baseline in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive (RFR), Role Function-Preventive (RFP) and Emotional Function (EF) domain scores, change in Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities (PDA) and Physical Impairment (PI) domain scores, and change in Headache Impact Test-6 (HIT-6) total score. Results: Of 744 randomized participants, 521 received atogepant 60 mg in the modified intent-to-treat population. Least-squares mean changes from baseline in MSQ-RFR score were 30.02 (95% confidence interval = 28.16–31.87) at week 12 and 34.70 (95% confidence interval = 32.74–36.66) at week 52. Improvements were also observed in other MSQ domains, AIM-D PDA, PI and HIT-6 total scores. A ≥5-point improvement from baseline in HIT-6 score was observed in 59.9% of participants at week 4 and 80.8% of participants at week 52. Conclusion: Over 52 weeks, atogepant 60 mg once-daily was associated with sustained improvements in quality of life and reductions in activity impairment and headache impact. Trial Registration: NCT03700320
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Cephalalgia |
| Vol/bind | 43 |
| Udgave nummer | 9 |
| Sider (fra-til) | 1-10 |
| ISSN | 0333-1024 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
We wish to express our appreciation to the patients who participated in the study, as well as the clinical and research personnel who were involved with conducting the trial at each of the participating centers. Without their support, we would not be able to further our understanding of migraine and develop new treatments. This study was sponsored by Allergan (prior to its acquisition by AbbVie); they contributed to the study design; to the collection, analysis and interpretation of data; and to the writing, reviewing and approval of the final version. No honoraria or payments were made for authorship. Medical writing support was provided by Cory R. Hussar, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie.
Funding Information:
Richard B. Lipton, MD, serves on the editorial boards of Neurology and Cephalalgia and is a senior advisor for Headache. He has received research support from the National Institutes of Health. He also receives support from the Migraine Research Foundation and the National Headache Foundation. He has reviewed for the National Institute on Aging and National Institute of Neurological Disorders and Stroke; serves as consultant, advisory board member, or has received honoraria or research support from AbbVie, Amgen, Biohaven, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Novartis, Teva, Vector and Vedanta Research. He receives royalties from Wolff’s Headache, 8th edition (Oxford University Press, 2009), and Informa. He holds stock options in Biohaven and Manistee.
Funding Information:
Messoud Ashina, MD, PhD, DMSc, reports personal fees from AbbVie, Amgen, Eli Lilly, Lundbeck, Novartis, Pfizer, and Teva; has received research funding from Lundbeck Foundation, Novo Nordisk Foundation, and Novartis; and serves as an associate editor for Cephalalgia, an associate editor for The Journal of Headache and Pain, and an associate editor for Brain.
Funding Information:
This study was sponsored by Allergan (prior to its acquisition by AbbVie); they contributed to the study design; to the collection, analysis and interpretation of data; and to the writing, reviewing and approval of the final version. No honoraria or payments were made for authorship. Medical writing support was provided by Cory R. Hussar, PhD, of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie.
Publisher Copyright:
© International Headache Society 2023.
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