Abstract
BackgroundPatients with high-frequency episodic migraine (HFEM) have a greater disease burden than those with low-frequency episodic migraine (LFEM). Acute treatment overuse increases the risk of migraine chronification in patients with HFEM. Galcanezumab, a humanized monoclonal antibody binding calcitonin gene-related peptide (CGRP), is effective for migraine prevention with a favorable safety profile. Here, we investigate whether there are differences in galcanezumab efficacy in patients with LFEM or with HFEM.MethodsData were pooled from two double-blind, placebo-controlled phase 3 trials; EVOLVE-1 and EVOLVE-2. Patients were 18–65 years old, experienced 4–14 monthly migraine headache days (MHDs) for ≥1 year prior, with onset at < 50 years of age. Migraine headaches were tracked via electronic patient-reported outcome system and randomization was stratified by low (LFEM; 4–7 monthly MHDs) or high (HFEM; 8–14 monthly MHDs) frequency. Subgroup analysis compared the HFEM and LFEM subgroups with a linear or generalized linear mixed model repeated measures approach.ResultsThe intent-to-treat patients (N = 1773) had a mean age of 41.3 years, were mostly white (75%), female (85%), and 66% of patients had HFEM. In both the LFEM and HFEM subgroups, the overall (Months 1–6) and monthly changes from baseline in monthly MHDs and monthly MHDs with acute medication use compared with placebo were statistically significantly reduced for galcanezumab 120-mg and 240-mg. Galcanezumab (120-mg and 240-mg) significantly decreased the overall and monthly MHDs with nausea and/or vomiting, and with photophobia and phonophobia versus placebo in patients with LFEM or HFEM. In both subgroups, the mean overall (Months 1–6) and monthly percentages of patients with ≥50%, ≥75%, and 100% reduction in monthly MHDs from baseline were statistically significantly greater in patients receiving either dose of galcanezumab versus placebo. Galcanezumab (120-mg and 240-mg) significantly improved the Migraine-Specific Quality of Life Questionnaire role function-restrictive domain score as well as the Migraine Disability Assessment total score versus placebo for patients with LFEM or HFEM. There were no significant subgroup-by-treatment interactions.ConclusionsGalcanezumab was as effective in patients with HFEM as in those with LFEM. Associated symptoms, quality of life, and disability were similarly improved in patients with HFEM or LFEM.Trial registrationNCT02614183, NCT02614196.
Highlights
Patients with high-frequency episodic migraine (HFEM) have a greater disease burden than those with low-frequency episodic migraine (LFEM)
Change in monthly migraine headache day (MHD) Galcanezumab 120-mg and 240-mg significantly reduced the mean number of monthly MHDs over the 6-month treatment period in patients with LFEM and in those with HFEM compared to placebo (Table 2)
The plots of percentage change in the galcanezumab treatment groups show that for every grouping by baseline number of MHDs, there was a similar set of results, with a few patients in most groups showing worsening from baseline, but a substantial number of patients in each group showing clinically significant improvement from baseline (> 50% reduction in MHDs relative to baseline) for the episodic migraine studies
Summary
Patients with high-frequency episodic migraine (HFEM) have a greater disease burden than those with low-frequency episodic migraine (LFEM). Its global age-standardized prevalence of 18.9% (95%UI: 18.1–19.7%) for women and 9.8% (95%UI: 9.4–10.2%) for men represents a world-wide total of 1.04 billion (95%UI: 1.00–1.09 billion) individuals with migraine [2] It is often under-treated and inadequately recognized [1,2,3]. 2% to 3% of patients with EM progress to CM annually [3, 5], and in one study, 26% of patients with CM reverted to EM over 2 years [5] This suggests there may be some overlap in biology between CM and EM experienced at higher frequencies; there may be differences in the responses of patients with high-frequency EM (HFEM) compared to those with low-frequency EM (LFEM)
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
