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Randomized Controlled Trial
. 2024 May 21;25(1):83.
doi: 10.1186/s10194-024-01783-6.

Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial

Richard B Lipton  1 , Stephanie J Nahas  2 , Patricia Pozo-Rosich  3   4 , Tanya Bilchik  5 , Peter McAllister  6 , Michelle Finnegan  7 , Yingyi Liu  7 , Natty Chalermpalanupap  7 , Brett Dabruzzo  8 , David W Dodick  9   10
Affiliations
Randomized Controlled Trial

Sustained response to atogepant in episodic migraine: post hoc analyses of a 12-week randomized trial and a 52-week long-term safety trial

Richard B Lipton et al. J Headache Pain. .

Abstract

Background: Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine in adults. These analyses evaluated the proportions of clinical trial participants who experienced sustained responses to atogepant over 12 or 52 weeks of treatment.

Methods: These were post hoc analyses of ADVANCE, a 12-week, double-blind, randomized trial of atogepant 10, 30, and 60 mg once daily vs. placebo for the preventive treatment of episodic migraine, and a separate open-label long-term safety (LTS) trial of atogepant 60 mg once daily over 52 weeks. The 60 mg dose of atogepant was used to detect safety issues. An initial response was defined as ≥50%, ≥75%, or 100% reduction from baseline in MMDs in month 1 for ADVANCE or quarter 1 for the LTS trial. The proportions of participants who continued to experience a response above each response-defining threshold through each subsequent month (for ADVANCE) or each quarter (for LTS) were calculated.

Results: In ADVANCE, sustained response rates during months 2 and 3 varied with dose and were as follows: 70.8-81.1% following an initial ≥50% response, 47.3-61.9% following an initial ≥75% response, and 34.8-41.7% following an initial 100% response. Of those who experienced an initial ≥75% or 100% response during month 1, more than 79% continued to experience at least a 50% response during both months 2 and 3. During the LTS trial, sustained response rates through quarters 2, 3, and 4 were 84.7% following an initial ≥50% response, 72.6% following an initial ≥75% response, and 37.8% following an initial 100% response. Of those who experienced an initial ≥75% or 100% response during quarter 1, more than 90% continued to experience at least a 50% response through quarters 2, 3, and 4.

Conclusion: Over 70% of participants who experienced an initial response with atogepant treatment had a sustained response with continued treatment.

Trial registration: ClinicalTrials.gov: NCT03777059 (submitted: December 13, 2018); NCT03700320 (submitted: September 25, 2018).

Keywords: CGRP; Migraine; Responders.

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Conflict of interest statement

RBL has received research support from the National Headache Foundation, the National Institutes of Health, and the US Food and Drug Administration. He serves as consultant for, advisory board member of, 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 Manistee. SJN has served as consultant for AbbVie, Eli Lilly, Lundbeck, Pfizer, Theranica, and Tonix. She has received honoraria for work in education or publishing from American Academy of Neurology, American Headache Society, Diamond Headache Clinic Research and Educational Foundation, MedLink Neurology, MJH Life Sciences, NACCME, Springer, WebMD/Medscape, and Wolters Kluwer. PP-R has received, in the last 3 years, personal fees for advisory boards and speaker panels from AbbVie, Amgen, Chiesi, Eli Lilly, Lundbeck, Medscape, Novartis, Pfizer, and Teva, and for serving on the scientific advisory board of Lilly Foundation Spain and Gadea Science Foundation. She is the principal investigator for clinical trials sponsored by AbbVie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis, and Teva. Her group has received grants from AbbVie, Era-Net Neuron, European Commission, Instituto Carlos III, International Headache Society, MINECO, Novartis, FEDER RIS3CAT, and Teva. She serves as an associate editor for Cephalalgia, Headache, Neurologia, The Journal of Headache and Pain, and Revista de Neurologia. She is the Honorary Secretary of the International Headache Society. She does not hold any stock or options. TB has participated in advisory boards for AbbVie, Biohaven, and Theranica. She is a clinical trial investigator for Lundbeck. PM has received research funding from AbbVie, Amgen, Biogen, Biohaven, EMD Serono, Lundbeck, Novartis, and Teva, and has received personal compensation for advisory boards and/or speakers bureaus for AbbVie, Aeon, Amgen, Biohaven, Lilly, Lundbeck, Revance, and Teva. MF was an employee of AbbVie at the time of study conduct and may hold AbbVie stock. DWD reports the following conflicts: Consulting: Amgen, Atria, CapiThera Ltd., Cerecin, Ceruvia Lifesciences LLC, CoolTech, Ctrl M, Allergan, AbbVie, Biohaven, Escient, GlaxoSmithKline, Halion, Lundbeck, Eli Lilly, Novartis, Impel, Satsuma, Theranica, WL Gore, Genentech, Nocira, Perfood, Praxis, AYYA Biosciences, Revance, Pfizer. Honoraria: American Academy of Neurology, Headache Cooperative of the Pacific, Headache Cooperative of New England, Canadian Headache Society, MF Med Ed Research, Biopharm Communications, CEA Group Holding Company (Clinical Education Alliance LLC), Teva (speaking), Amgen Japan (speaking), Eli Lilly Canada (speaking), Lundbeck (speaking), Pfizer (speaking), Vector Psychometric Group, Clinical Care Solutions, CME Outfitters, Curry Rockefeller Group, DeepBench, Global Access Meetings, KLJ Associates, Academy for Continued Healthcare Learning, Majallin LLC, Medlogix Communications, Medica Communications LLC, MJH Lifesciences, Miller Medical Communications, WebMD Health/Medscape, Wolters Kluwer, Oxford University Press, Cambridge University Press. Non-profit board membership: American Brain Foundation, American Migraine Foundation, ONE Neurology, Precon Health Foundation, Global Patient Advocacy Coalition, Atria Health Collaborative, Atria Academy of Science and Medicine, Arizona Brain Injury Alliance, Domestic Violence HOPE Foundation/Panfila, CSF Leak Foundation. Research support: Department of Defense, National Institutes of Health, Henry Jackson Foundation, Sperling Foundation, American Migraine Foundation, Patient-Centered Outcomes Research Institute (PCORI). Stock options/shareholder/patents/board of directors: Ctrl M (options), Aural Analytics (options), Axon Therapeutics (board/options), ExSano (options), Palion (options), Keimon Medical (options), Man and Science, Healint (options), Theranica (options), Second Opinion/Mobile Health (options), Epien (options), Nocira (options), Matterhorn (shares), Ontologics (shares), King-Devick Technologies (options/board), Precon Health (options/board), ScotiaLyfe (board), EigenLyfe (options/board), AYYA Biosciences (options), Axon Therapeutics (options/board), Cephalgia Group (options/board), Atria Health (options/employee). Patent 17189376.1-1466:vTitle: Onabotulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis (non-royalty bearing). Patent application submitted: Synaquell® (Precon Health). YL, NC, and BD are employees of AbbVie and may hold AbbVie stock.

Figures

Fig. 1
Fig. 1
Sustained Response in Both Months 2 and 3 Among Participants With a ≥50% Response in Month 1 (ADVANCE). MMDs, monthly migraine days; N, participants with a ≥50% reduction in MMDs in month 1; n, number of participants within a specific category; N1, number of participants available for analysis
Fig. 2
Fig. 2
Sustained Response of ≥50% in Both Months 2 and 3 Among Participants With a ≥75% Response in Month 1 (ADVANCE). MMDs, monthly migraine days; N, participants with a ≥75% reduction in MMDs in month 1; n, number of participants within a specific category; N1, number of participants available for analysis
Fig. 3
Fig. 3
Sustained Response of ≥50% in Both Months 2 and 3 Among Participants With a 100% Response in Month 1 (ADVANCE). MMDs, monthly migraine days; N, participants with a 100% reduction in MMDs in month 1; n, number of participants within a specific category; N1, number of participants available for analysis
Fig. 4
Fig. 4
Delayed Response of ≥50% Among Participants Without a ≥50% Response in Month 1 (a) and Months 1 and 2 (b) (ADVANCE). MMDs, monthly migraine days; N, total number of participants included in the modified intent-to-treat population; n, number of participants not achieving response; N1, total number of participants with determinable data
Fig. 5
Fig. 5
Sustained Response Over 52 Weeks Among Participants With a ≥50% Response in Q1 (52-Week Trial). MMDs, monthly migraine days; N, participants included in the modified intent-to-treat population; n, number of Q1 with initial response who had sustained response in Q2, Q2–Q3, or Q2–Q4; N1, number of Q1 with initial response from participants with determinable data at Q2, Q2–Q3, or Q2–Q4; Q, quarter
Fig. 6
Fig. 6
Sustained Response of ≥50% Over 52 Weeks Among Participants With a ≥75% Response in Q1 (52-Week Trial). MMDs, monthly migraine days; N, participants included in the modified intent-to-treat population; n, number of Q1 with initial response who had sustained response in Q2, Q2–Q3, or Q2–Q4; N1, number of Q1 with initial response from participants with determinable data at Q2, Q2–Q3, or Q2–Q4; Q, quarter
Fig. 7
Fig. 7
Sustained Response of ≥50% Over 52 Weeks Among Participants With a 100% Response in Q1 (52-Week Trial). MMDs, monthly migraine days; N, participants included in the modified intent-to-treat population; n, number of Q1 with initial response who had sustained response in Q2, Q2–Q3, or Q2–Q4; N1, number of Q1 with initial response from participants with determinable data at Q2, Q2–Q3, or Q2–Q4; Q, quarter
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