Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial
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Objective: To assess long-term safety, tolerability, and efficacy of once-daily oral atogepant 60 mg in adults with migraine. Background: Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist approved for the preventive treatment of episodic migraine. Methods: A 52-week, multicenter, randomized, open-label trial of adults (18–80 years) with migraine. Lead-in trial completers or newly enrolled participants with 4–14 migraine days/month were enrolled and randomized (5:2) to atogepant 60 mg once daily or oral standard care (SC) migraine preventive medication. The primary objective was to evaluate the safety and tolerability of atogepant; safety assessments included treatment-emergent adverse events (TEAEs), clinical laboratory evaluations, vital signs, and Columbia-Suicide Severity Rating Scale scores. Efficacy assessments (atogepant only) included change from baseline in mean monthly migraine days (MMDs) and the proportion of participants with reductions from baseline of ≥50%, ≥75%, and 100% in MMDs. Results: The trial included 744 participants randomized to atogepant 60 mg (n = 546) or SC (n = 198). The atogepant safety population was 88.2% female (n = 479/543) with a mean (standard deviation) age of 42.5 (12.0) years. TEAEs occurred in 67.0% (n = 364/543) of participants treated with atogepant 60 mg. The most commonly reported TEAEs (≥5%) were upper respiratory tract infection (10.3%; 56/543), constipation (7.2%; 39/543), nausea (6.3%; 34/543), and urinary tract infection (5.2%; 28/543). Serious TEAEs were reported in 4.4% (24/543) for atogepant. Mean (standard error) change in MMDs for atogepant was −3.8 (0.1) for weeks 1–4 and −5.2 (0.2) at weeks 49–52. Similarly, the proportion of participants with ≥50%, ≥75%, and 100% reductions in MMDs increased from 60.4% (310/513), 37.2% (191/513), and 20.7% (106/513) at weeks 1–4 to 84.2% (282/335), 69.9% (234/335), and 48.4% (162/335), at weeks 49–52. Conclusion: Daily use of oral atogepant 60 mg for preventive treatment of migraine during this 1-year, open-label trial was safe, well tolerated, and efficacious.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Headache |
| Vol/bind | 63 |
| Udgave nummer | 1 |
| Sider (fra-til) | 79-88 |
| Antal sider | 10 |
| ISSN | 0017-8748 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
(MA) is a consultant, speaker, or scientific advisor for AbbVie/Allergan, Alder, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, Pfizer and Teva, and primary investigator for AbbVie/Allergan, Alder, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva trials. MA has no ownership interest and does not own stocks of any pharmaceutical company. MA serves as associate editor of associate editor of , associate editor of . (SJT) has served as a consultant for Acorda, Alder, Alexsa, Alphasights, Amgen, ATI, Axsome Therapeutics, BioDelivery Sciences International, Biohaven, Charleston Labs, Decision Resources, DeepBench, Dr. Reddy's, electroCore, Eli Lilly, eNeura, GLG, GSK, Guidepoint Global, Impel, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurolief, Nordic BioTech, Novartis, Pfizer, Reckner Healthcare, Relevale, Satsuma, Scion Neurostim, Slingshot Insights, Sorrento, Sudler and Hennessey, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC, and Zosano. SJT receives a salary as editor‐in‐chief of from the American Headache Society and receives royalties for books published by Springer. (UR) is a consultant, speaker, or scientific advisor for AbbVie, Amgen, CoLucid, Lilly, Lundbeck, Medscape, Novartis, Perfood, Pfizer, and Teva. UR serves as associate editor of and of . UR is board member of the European Headache Federation. (AMB) has served on advisory boards for AbbVie, Aeon, Alder, Allergan, Amgen, Axsome, Biohaven, Impel, Lundbeck, Lilly, Novartis, Revance, Teva, Theranica, and Zoscano and has received funding for speaking from AbbVie, Allergan, Amgen, Biohaven, Lundbeck, Lilly, and Teva. AMB is a consultant for AbbVie, Alder, Allergan, Amgen, Biohaven, Lilly, Lundbeck, Novartis, Teva, and Theranica and has received grant support from Allergan and Amgen. He is a contributing author for AbbVie, Allergan, Amgen, Biohaven, Novartis, Lilly, and Teva. (SH) has served on advisory boards for AbbVie, Alder/Lundbeck, Amgen, Biohaven, Currax, electroCore, Eli Lilly, Impel, Novartis, Teva, Theranica, and Upsher‐Smith. SH is on the speakers bureaus for AbbVie, Amgen, Biohaven, electroCore, Eli Lilly, Lundbeck, Novartis, Teva, Theranica, and Upsher‐Smith. is an employee of AbbVie and may hold AbbVie stock. , , , and were employees of AbbVie at the time of study conduct and may hold AbbVie stock. Messoud Ashina Cephalalgia, The Journal of Headache and Pain Brain Stewart J. Tepper Headache Currents Uwe Reuter Frontiers in Neurology The Journal of Headache and Pain Andrew M. Blumenfeld Susan Hutchinson Joel M. Trugman Michelle Finnegan Jing Xia Rosa Miceli Lawrence Severt
Funding Information:
This study was sponsored by Allergan (prior to its acquisition by AbbVie). Allergan (now AbbVie) also participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.
Publisher Copyright:
© 2023 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
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