Migraines have a significant impact on patients’ daily activity and quality of life, suggesting that assessments of these areas should be incorporated into treatment approaches as well as clinical research, according to the study results published in Headache. The results also showed that treatment with galcanezumab can improve the quality of life in these patients.
This post-hoc study investigated whether an improvement in response to daytime migraine headache was related to a significant improvement in patient function in the areas of quality of life. An attempt was also made to test whether patients treated with galcanezumab would experience greater improvements than patients treated with placebo.
A team of researchers from the United States and Germany analyzed data from three double-blind phase 3 studies in adults with episodic migraine (EM) or chronic migraine (CM). The EM studies included EVOLVE-1 (ClinicalTrials.gov identifier: NCT02614183; n = 858) and EVOLVE-2 (ClinicalTrials.gov identifier: NCT02614196; n = 915), while the REGAIN study (ClinicalTrials.gov- Identifier: NCT02614261; n =) 1113) delivered data for CM.
In EVOLVE-1 and -2, patients were randomly assigned subcutaneous injections of placebo, 120 mg galcanezumab, or 240 mg galcanezumab once monthly for 6 months. In REGAIN, participants were also treated with placebo, 120 mg galcanezumab or 240 mg galcanezumab once a month, but the treatment lasted only 3 months.
The primary result was the mean change from baseline in the number of monthly migraine headache days. In addition, the study researchers rated the results reported by patients using the 14-point questionnaire on migraine-specific quality of life, version 2.1 (MSQ) and the questionnaire on the assessment of migraine disability (MIDAS).
The mean improvements from baseline in MSQ domain scores increased with each subsequent daily migraine headache response level in patients with migraine. The increase in the role-limiting score in EM was 16.8 for “less than 30 percent” and 36.0 for “at least 75 percent”. In CM, there was an increase of 10.7 for the “less than 30 percent” and 46.5 for the “75 percent or more” response levels in the role function-restrictive score. The study researchers found similar patterns in the areas of role function prevention and emotional functioning.
In patients with EM, more patients treated with galcanezumab showed improvements across all 14 MSQ items than did patients treated with placebo. The therapeutic gains in patients with EM treated with galcanezumab ranged from 10 to 20 percent (P <0.001). Similarly, in patients with CM, more patients showed improvements in all MSQ items compared to those treated with placebo, but these differences were only significant in 19 out of 28 comparisons. The therapeutic gains in patients with CM treated with galcanezumab ranged from 3 to 16 percent.
In patients with EM and CM, severe severe disability and very severe disability were observed at baseline, based on mean baseline MIDAS values (33.1 and 67.2, respectively). In patients with EM, 50.6 percent of patients treated with 120 mg galcanezumab and 51.3 percent of patients treated with 240 mg galcanezumab had little or no migraine-related disability after 6 months, compared with 33.3 percent of placebo-treated patients (P <0.001). . And in patients with CM, 19.7 percent of patients who received 120 mg galcanezumab and 20.9 percent of patients who received 240 mg galcanezumab had little or no migraine-related disability after three months of treatment, compared with 13.9 Percent of patients in the placebo arm (P = 0.045 for the 120 mg group; P = 0.017 for 240 mg).
This study was limited due to its limitation to cohorts in three clinical trials, indicating a possible lack of generalizability in a wider population of migraineurs. In addition, biases in the report could have influenced the results.
Based on their results, the researchers concluded that migraine management should consider not only the headache, nausea, and increased sensitivities associated with a migraine attack, but also the impact that migraine attacks have on a patient’s daily activities have migraines. ”
Ford JH, Kurth T., Starling AJ, et al. Migraine Headache Day Response Rates and Effects on Patient Function: An Evaluation of 3 Phase 3 Randomized Clinical Trials of Galcanezumab in Patients with Migraine. A headache. 2020; 60 (10): 2304-2. 2319. doi: 10.1111 / head.14013