Evaluating the clinical utility of the patient‐identified most bothersome symptom measure from PROMISE‐2 for research in migraine prevention

Autor: Richard B. Lipton, Peter J. Goadsby, David W. Dodick, James S. McGinley, Carrie R. Houts, R. J. Wirth, Steve Kymes, Anders Ettrup, Ole Østerberg, Roger Cady, Messoud Ashina, Dawn C. Buse
Rok vydání: 2022
Předmět:
Zdroj: Lipton, R B, Goadsby, P J, Dodick, D W, McGinley, J S, Houts, C R, Wirth, R J, Kymes, S, Ettrup, A, Østerberg, O, Cady, R, Ashina, M & Buse, D C 2022, ' Evaluating the clinical utility of the patient-identified most bothersome symptom measure from PROMISE-2 for research in migraine prevention ', Headache, vol. 62, no. 6, pp. 690-699 . https://doi.org/10.1111/head.14295
ISSN: 1526-4610
0017-8748
DOI: 10.1111/head.14295
Popis: Objective: To assess the utility of the novel patient-identified (PI) most bothersome symptom (MBS) measure from PROMISE-2, a phase 3 trial of eptinezumab for the preventive treatment of chronic migraine. Background: Relief of bothersome migraine symptoms can influence satisfaction with treatment and therapeutic persistence. Understanding the impact of preventive treatment on a PI-MBS could improve clinical decision-making. Methods: In PROMISE-2, patients with chronic migraine received eptinezumab 100, 300 mg, or placebo administered intravenously every 12 weeks for up to 2 doses (n = 1072). PI-MBS was an exploratory outcome requiring each patient to self-report their MBS in response to an open-ended question. At baseline and week 12, patients rated overall improvement in PI-MBS. The relationships among PI-MBS at week 12 and change in monthly migraine days (MMDs) from baseline to month 3 (weeks 9–12), Patient Global Impression of Change at week 12, and changes from baseline to week 12 in the 6-item Headache Impact Test total, EuroQol 5-dimensions 5-levels visual analog scale, and 36-item Short-Form Health Survey component scores were assessed. Results: Treatment groups had similar baseline characteristics and reported a total of 23 unique PI-MBS, most commonly light sensitivity (200/1072, 18.7%), nausea/vomiting (162/1072, 15.1%), and pain with activity (147/1072, 13.7%). Improvements in PI-MBS at week 12 correlated with changes in MMDs (ρ = −0.49; p
Databáze: OpenAIRE
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