Effect of Atogepant for Preventive Migraine Treatment on Patient-Reported Outcomes in the Randomized, Double-blind, Phase 3 ADVANCE Trial
Lipton, Richard B. (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Pozo-Rosich, Patricia (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Blumenfeld, Andrew M. (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Li, Ye (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Severt, Lawrence (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Stokes, Jonathan T. (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Creutz, Lela (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Gandhi, Pranav (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Dodick, David (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Universitat Autònoma de Barcelona

Data:	2023
Resum:	The oral calcitonin gene-related peptide receptor antagonist atogepant is indicated for the preventive treatment of episodic migraine. We evaluated changes in patient-reported outcomes with atogepant in adults with migraine. In this phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial (ADVANCE), adults with 4-14 migraine days per month received atogepant (10, 30, or 60 mg) once daily or placebo. Secondary endpoints included changes from baseline in Migraine-Specific Quality-of-Life Questionnaire (MSQ) version 2. 1 Role Function-Restrictive (RFR) domain at week 12 and mean monthly Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities (PDA) and Physical Impairment (PI) domains across the 12-week treatment period. Exploratory endpoints included change in MSQ Role Function-Preventive (RFP) and Emotional Function (EF) domains; AIM-D total scores; and change in Headache Impact Test (HIT)-6 scores. Of 910 participants randomized, 873 comprised the modified intent-to-treat population (atogepant: 10 mg [n = 214]; 30 mg [n = 223]; and 60 mg [n = 222]; placebo [n = 214]). All atogepant groups demonstrated significantly greater improvements vs placebo in MSQ RFR that exceeded minimum clinically meaningful between-group difference (3. 2 points) at week 12 (least-square mean difference [LSMD] vs placebo: 10 mg [9. 9]; 30 mg [10. 1]; 60 mg [10. 8]; all p < 0. 0001). LSMDs in monthly AIM-D PDA and PI scores across the 12-week treatment period improved significantly for the atogepant 30 (PDA: −2. 54; p = 0. 0003; PI: −1. 99; and p = 0. 0011) and 60 mg groups (PDA: −3. 32; p < 0. 0001; PI: −2. 46; p < 0. 0001), but not for the 10 mg group (PDA: −1. 19; p = 0. 086; PI: −1. 08; p = 0. 074). In exploratory analyses, atogepant 30 and 60 mg were associated with nominal improvements in MSQ RFP and EF domains, other AIM-D outcomes, and HIT-6 scores at the earliest time point (week 4) and throughout the 12-week treatment period. Results varied for atogepant 10 mg. Atogepant 30 and 60 mg produced significant improvements in key patient-reported outcomes including MSQ-RFR scores and both AIM-D domains. Nominal improvements also occurred for other MSQ domains and HIT-6, reinforcing the beneficial effects of atogepant as a new treatment for migraine prevention. NCT03777059. Submitted: December 13, 2018; First patient enrolled: December 14, 2018. This study provides Class II evidence that daily atogepant is associated with improvements in health-related quality-of-life measures in patients with 4-14 migraine days per month.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Neurology, Vol. 100 (february 2023) , p. e764-e777, ISSN 1526-632X

DOI: 10.1212/WNL.0000000000201568
PMID: 36396451

14 p, 1.5 MB

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