Evaluating the clinical utility of the patient-identified most bothersome symptom measure from PROMISE-2 for research in migraine prevention.
chronic migraine
eptinezumab
most bothersome symptom
patient-identified most bothersome symptom
Journal
Headache
ISSN: 1526-4610
Titre abrégé: Headache
Pays: United States
ID NLM: 2985091R
Informations de publication
Date de publication:
06 2022
06 2022
Historique:
revised:
08
03
2022
received:
09
11
2021
accepted:
08
03
2022
pubmed:
26
4
2022
medline:
24
6
2022
entrez:
25
4
2022
Statut:
ppublish
Résumé
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. 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. 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. 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 < 0.0001) and other patient-reported outcomes. Controlling for changes in MMDs, PI-MBS improvement predicted other patient-reported outcomes in expected directions. The magnitude of the standardized mean differences between placebo and active treatment for PI-MBS were 0.31 (p < 0.0001 vs. placebo) and 0.54 (p < 0.0001 vs. placebo) for eptinezumab 100 and 300 mg, respectively. Improvement in PI-MBS at week 12 was associated with improvement in other patient-reported outcome measures, and PI-MBS may be an important patient-centered measure of treatment benefits in patients with chronic migraine.
Sections du résumé
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 < 0.0001) and other patient-reported outcomes. Controlling for changes in MMDs, PI-MBS improvement predicted other patient-reported outcomes in expected directions. The magnitude of the standardized mean differences between placebo and active treatment for PI-MBS were 0.31 (p < 0.0001 vs. placebo) and 0.54 (p < 0.0001 vs. placebo) for eptinezumab 100 and 300 mg, respectively.
CONCLUSIONS
Improvement in PI-MBS at week 12 was associated with improvement in other patient-reported outcome measures, and PI-MBS may be an important patient-centered measure of treatment benefits in patients with chronic migraine.
Identifiants
pubmed: 35466430
doi: 10.1111/head.14295
pmc: PMC9325355
doi:
Types de publication
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
690-699Informations de copyright
© 2022 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
Références
J Neurosci. 2015 Apr 29;35(17):6619-29
pubmed: 25926442
Qual Life Res. 2003 Dec;12(8):963-74
pubmed: 14651415
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
Headache. 2022 Jun;62(6):690-699
pubmed: 35466430
J Headache Pain. 2020 Oct 6;21(1):120
pubmed: 33023473
Neurology. 2020 Mar 31;94(13):e1365-e1377
pubmed: 32209650
Physiol Rev. 2017 Apr;97(2):553-622
pubmed: 28179394
Headache. 2021 Feb;61(2):263-275
pubmed: 33611818
Headache. 2020 Feb;60(2):416-429
pubmed: 31837007
Cephalalgia. 2013 Jul;33(9):629-808
pubmed: 23771276
Headache. 2020 Oct;60(9):2003-2013
pubmed: 32862469
Psychol Bull. 1992 Jul;112(1):155-9
pubmed: 19565683
Cephalalgia. 2018 Jan;38(1):1-211
pubmed: 29368949
Ann Acad Med Singap. 2020 Apr;49(4):226-235
pubmed: 32419007
Qual Life Res. 2021 Mar;30(3):931-943
pubmed: 33079313
Cephalalgia. 2019 May;39(6):687-710
pubmed: 30806518
F1000Res. 2018 Feb 14;7:188
pubmed: 29511532
Headache. 1995 Jul-Aug;35(7):387-96
pubmed: 7672955
J Headache Pain. 2018 Nov 15;19(1):109
pubmed: 30442090
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9
pubmed: 11124729
Headache. 2018 Oct;58(9):1408-1426
pubmed: 30341895
Headache. 2001 Jul-Aug;41(7):646-57
pubmed: 11554952
N Engl J Med. 2020 Nov 5;383(19):1866-1876
pubmed: 33211930
Headache. 2021 Feb;61(2):253-262
pubmed: 33600610