Migraine Headache Day Response Rates and the Implications to Patient Functioning: An Evaluation of 3 Randomized Phase 3 Clinical Trials of Galcanezumab in Patients With Migraine

Objective This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient‐reported outcomes of health‐related quality of life (HRQoL) and disability categories. Background Migraine causes considerable disease‐related disability and n...

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Bibliographic Details
Published in:Headache 2020-11, Vol.60 (10), p.2304-2319
Main Authors: Ford, Janet H., Kurth, Tobias, Starling, Amaal J., Ayer, David W., Wietecha, Linda A., Port, Martha D., Rettiganti, Mallikarjuna, Ruff, Dustin D.
Format: Article
Language:English
Subjects:
Activities of daily living
Calcitonin
calcitonin gene‐related peptide
chronic migraine
Clinical trials
Domains
episodic migraine
galcanezumab
Headache
Headaches
Health services
Migraine
Monoclonal antibodies
Patients
patient‐reported outcomes
Peptide inhibitors
Quality of life
Questionnaires
Research Submission
Research Submissions
Statistical analysis
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Summary:Objective This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient‐reported outcomes of health‐related quality of life (HRQoL) and disability categories. Background Migraine causes considerable disease‐related disability and negatively impacts HRQoL of patients. Calcitonin gene‐related peptide inhibitors improve these outcomes and may eliminate disability due to migraine in some patients. Methods Analyses used data from 3 double‐blind, placebo (PBO)‐controlled, phase 3 studies in adults with episodic migraine (EM) (EVOLVE‐1: N = 858 and EVOLVE‐2: N = 915) or chronic migraine (CM) (REGAIN: N = 1113). Patients were randomized 2:1:1 to subcutaneous injection of PBO, galcanezumab (GMB) 120 mg, or GMB 240 mg once monthly for 6 months in EVOLVE‐1 and ‐2 and for 3 months in REGAIN. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Patients were divided into 4 response‐level groups based on percent change from baseline (
ISSN:0017-8748
1526-4610
DOI:10.1111/head.14013