Migraine substantially impacts patients’ daily activity and quality of life (QoL), suggesting the assessments of these domains should be incorporated into treatment approaches as well as clinical research, according to study results published in Headache. Results also indicated that treatment with galcanezumab may improve QoL in these patients.
This post-hoc study sought to determine whether improvement in migraine headache day response was related to significant improvements in patient functioning in the domains of QoL. It additionally sought to test whether patients treated with galcanezumab would experience greater improvements than those treated with placebo.
A team of researchers from the United States and Germany analyzed data from 3 double-blind phase 3 studies of adults with episodic migraine (EM) or chronic migraine (CM). Studies in EM included EVOLVE-1 (ClinicalTrials.gov Identifier: NCT02614183; n=858) and EVOLVE-2 (ClinicalTrials.gov Identifier: NCT02614196; n=915), whereas the REGAIN trial (ClinicalTrials.gov Identifier: NCT02614261; n=1113) provided data for CM.
In EVOLVE-1 and -2, patients were randomly assigned to subcutaneous injections of either placebo, 120 mg galcanezumab, or 240 mg galcanezumab once every month for 6 months. In REGAIN, participants were also assigned to either placebo, 120 mg galcanezumab, or 240 mg galcanezumab once every month, but treatment lasted for only 3 months.
The primary outcome was the overall average change from baseline in the number of monthly migraine headache days. Additionally, the study researchers assessed patient-reported outcomes through the 14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire.
The average improvements from baseline in MSQ domain scores rose with each successive migraine headache day response level in patients with migraine. Increases in Role Function-Restrictive score in EM were 16.8 at the “less than 30 percent” and 36.0 at the “at least 75 percent” response levels. In CM, there were increases of 10.7 in the “less than 30 percent” and 46.5 in the “at least 75 percent” response levels in the Role Function-Restrictive score. The study researchers noted similar patterns for the Role Function-Preventive and Emotional Function domains.
Among patients with EM, more patients treated with galcanezumab experienced improvements in all 14 MSQ items than those treated with placebo. Therapeutic gains for patients with EM treated with galcanezumab were between 10 and 20 percent (P <.001). Similarly, among patients with CM, more patients experienced improvements in all MSQ items compared with those treated by placebo, but these differences were only significant in 19 of 28 comparisons. Therapeutic gains for patients with CM treated with galcanezumab were between 3 and 16 percent.
Severe mean disability and very severe disability were observed at baseline in patients with EM and CM, respectively, based on the mean baseline MIDAS scores (33.1 and 67.2, respectively). In patients with EM, 50.6 percent of those who received 120 mg galcanezumab and 51.3 percent of those treated with 240 mg galcanezumab had little or no migraine-related disability after 6 months compared with 33.3 percent of patients treated with placebo (P <.001). And in patients with CM, 19.7 percent of those who received 120 mg galcanezumab and 20.9 percent of those who received 240 mg galcanezumab had little or no migraine-related disability after 3 months of treatment compared with 13.9 percent of patients in the placebo arm (P =.045 for 120 mg group; P =.017 for 240 mg).
This study was limited by its restriction to cohorts across 3 clinical trials, suggesting a potential lack of generalizability across a broader population of patients with migraine. Additionally, reporting biases may have influenced results.
Based on their findings, the study researchers concluded that the management “of migraine should address not only the headache pain, nausea, and heightened sensitivities associated with a migraine attack, but also the impact that migraine attacks have on the daily activities of a patient with migraine.”
Ford JH, Kurth T, Starling AJ, et al. 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. Headache. 2020;60(10):2304-2319. doi:10.1111/head.14013