TY - JOUR
T1 - Time course of efficacy of atogepant for the preventive treatment of migraine
T2 - Results from the randomized, double-blind ADVANCE trial
AU - Schwedt, Todd J.
AU - Lipton, Richard B.
AU - Ailani, Jessica
AU - Silberstein, Stephen D.
AU - Tassorelli, Cristina
AU - Guo, Hua
AU - Lu, Kaifeng
AU - Dabruzzo, Brett
AU - Miceli, Rosa
AU - Severt, Lawrence
AU - Finnegan, Michelle
AU - Trugman, Joel M.
N1 - Funding Information:
Richard B Lipton has received research support from the National Institutes of Health, the FDA, and the National Headache Foundation. He serves as consultant, advisory board member, or has received honoraria or research support from AbbVie/Allergan, Amgen, Biohaven, Dr. Reddy’s Laboratories (Promius), electroCore, Eli Lilly, GlaxoSmithKline, Lundbeck, 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 Ctrl M.
Funding Information:
Cristina Tassorelli has participated in advisory boards for AbbVie, electroCore, Eli Lilly, Novartis, and Teva. She has lectured at symposia sponsored by AbbVie, Eli Lilly, Novartis, and Teva. She is principal investigator or collaborator in clinical trials sponsored by Alder, Eli Lilly, IBSA, Novartis, and Teva. She has received research grants from the European Commission, the Italian Ministry of Health, the Italian Ministry of University, the Migraine Research Foundation, and the Italian Multiple Sclerosis Foundation.
Funding Information:
The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was sponsored by Allergan (prior to its acquisition by AbbVie).
Funding Information:
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Todd J Schwedt serves on the Board of Directors for the American Headache Society and the International Headache Society. He has received research support from the American Migraine Foundation, Amgen, Henry Jackson Foundation, National Institutes of Health, Patient-Centered Outcomes Research Institute, and US Department of Defense. Within the past 12 months, he has received personal compensation for serving as a consultant or advisory board member for AbbVie/Allergan, Biohaven, Eli Lilly, Equinox, Lundbeck, and Novartis. He has received royalties from UpToDate. He holds stock options in Aural Analytics and Nocira.
Funding Information:
Writing and editorial assistance was provided to the authors by Cory Hussar of Peloton Advantage, LLC, an OPEN Health company, Parsippany, NJ, and was funded by AbbVie. The opinions expressed in this article are those of the authors. The authors received no honorarium/fee or other form of financial support related to the development of this article.
Publisher Copyright:
© International Headache Society 2021.
PY - 2022/1
Y1 - 2022/1
N2 - Background: Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist for the preventive treatment of migraine. Methods: In the double-blind, phase 3 ADVANCE trial, participants with 4–14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo once daily for 12 weeks. We evaluated the time course of efficacy of atogepant for the preventive treatment of migraine. Analyses included change from baseline in mean monthly migraine days during each of the three 4-week treatment periods, change in weekly migraine days during weeks 1–4, and proportion of participants with a migraine on each day during the first week. Results: We analyzed 873 participants (n = 214 atogepant 10 mg, n = 223 atogepant 30 mg, n = 222 atogepant 60 mg, n = 214 placebo). For weeks 1–4, mean change from baseline in mean monthly migraine days ranged from −3.1 to −3.9 across atogepant doses vs −1.6 for placebo (p < 0.0001). For weeks 5–8 and 9–12, reductions in mean monthly migraine days ranged from −3.7 to −4.2 for atogepant vs −2.9 for placebo (p ≤ 0.012) and −4.2 to −4.4 for atogepant vs −3.0 for placebo (p < 0.0002), respectively. Mean change from baseline in weekly migraine days in week 1 ranged from −0.77 to −1.03 for atogepant vs −0.29 with placebo (p < 0.0001). Percentages of participants reporting a migraine on post-dose day 1 ranged from 10.8% to 14.1% for atogepant vs 25.2% with placebo (p ≤ 0.0071). Conclusion: Atogepant demonstrated treatment benefits as early as the first full day after treatment initiation, and sustained efficacy across each 4-week interval during the 12-week treatment period. Clinical trial registration: ClinicalTrials.gov identifier: NCT03777059.
AB - Background: Atogepant is an oral, small-molecule, calcitonin gene–related peptide receptor antagonist for the preventive treatment of migraine. Methods: In the double-blind, phase 3 ADVANCE trial, participants with 4–14 migraine days/month were randomized to atogepant 10 mg, 30 mg, 60 mg, or placebo once daily for 12 weeks. We evaluated the time course of efficacy of atogepant for the preventive treatment of migraine. Analyses included change from baseline in mean monthly migraine days during each of the three 4-week treatment periods, change in weekly migraine days during weeks 1–4, and proportion of participants with a migraine on each day during the first week. Results: We analyzed 873 participants (n = 214 atogepant 10 mg, n = 223 atogepant 30 mg, n = 222 atogepant 60 mg, n = 214 placebo). For weeks 1–4, mean change from baseline in mean monthly migraine days ranged from −3.1 to −3.9 across atogepant doses vs −1.6 for placebo (p < 0.0001). For weeks 5–8 and 9–12, reductions in mean monthly migraine days ranged from −3.7 to −4.2 for atogepant vs −2.9 for placebo (p ≤ 0.012) and −4.2 to −4.4 for atogepant vs −3.0 for placebo (p < 0.0002), respectively. Mean change from baseline in weekly migraine days in week 1 ranged from −0.77 to −1.03 for atogepant vs −0.29 with placebo (p < 0.0001). Percentages of participants reporting a migraine on post-dose day 1 ranged from 10.8% to 14.1% for atogepant vs 25.2% with placebo (p ≤ 0.0071). Conclusion: Atogepant demonstrated treatment benefits as early as the first full day after treatment initiation, and sustained efficacy across each 4-week interval during the 12-week treatment period. Clinical trial registration: ClinicalTrials.gov identifier: NCT03777059.
KW - Atogepant
KW - calcitonin gene–related peptide
KW - efficacy
KW - time course
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U2 - 10.1177/03331024211042385
DO - 10.1177/03331024211042385
M3 - Article
C2 - 34521260
AN - SCOPUS:85115037300
SN - 0333-1024
VL - 42
SP - 3
EP - 11
JO - Cephalalgia
JF - Cephalalgia
IS - 1
ER -