Galcanezumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody, has been linked to a reduction in the frequency of migraine headache days and a reduction in potentially inactivating non-painful symptoms associated with episodic migraines (EM) and chronic migraines (CM) Journal of Headache Pain suggests.
This study was an analysis of 3 randomized, placebo-controlled phase 3 studies in which patients with EM or CH were recruited. The 2 EM studies, which lasted 6 months, included a total of 1773 patients with 4 to 14 monthly migraine headache days. A total of 1113 patients with CM with or without aura and 15 or more headache days per month were enrolled in the single 3-month CM study.
In the EM studies, patients were randomly assigned to either placebo (n = 894) or 120 mg galcanezumab per month (n = 444) with a loading dose of 240 mg or 240 mg galcanezumab per month (n = 435).
In the CH study, patients were also randomized to receive either placebo (n = 558) or 120 mg (n = 278) galcanezumab per month with a loading dose of 240 mg or 240 mg (n = 277) galcanezumab per month.
For each headache, patients recorded its characteristics, duration, and severity, as well as the presence of the associated symptoms.
The investigators of the study analyzed, among other things, changes in the number of monthly migraine headache days with nausea and / or vomiting compared to the initial value. Additional results for the studies were the number of moderate to severe monthly migraine headache days, the number of severe migraine headache days, and the average severity of the remaining migraine headache days.
In the EM studies, treatment with galcanezumab was associated with a significantly higher mean reduction in the number of monthly migraine headache days with nausea or vomiting over every 6 months (120 mg: mean difference, -0.95 days; 95% CI, -1, 19 to – 0.70; P <0.001; 240 mg: mean difference, -0.88 days; 95% CI, -1.13 to -0.63; P <0.001).
The investigators of the study saw similar significant improvements compared to placebo in the CM study (120 mg: mean difference -1.21 days; 95% CI 1.82 to -0.59; P <0.001; 240 mg: mean difference -1 , 28 days; 95%) CI -1.90 to -0.66; P <0.001).
Treatment with galcanezumab in the EM and CM studies was also associated with greater reductions in the frequency of migraine headache days with migraine-related symptoms such as nausea and / or vomiting, photophobia and phonophobia, and prodromal symptoms.
In the EM studies, galcanezumab reduced the frequency of migraine headache days with aura compared to placebo (120 mg: mean difference, -0.46 days; 95% CI, -0.67 to -0.24; P <0.001; 240 mg : mean difference, -0.45 days; 95% CI, -0.67 to -0.24; P <0.001).
The limitations of this analysis included its post-hoc nature as well as the inclusion of studies that relied on self-reports for the presence of an aura.
The study’s authors concluded: “Overall, this study shows that while treatment with galcanezumab reduces the frequency of migraine days compared to placebo, it also reduces potential disability [nonpain] Symptoms even on days when migraines are present. ”
Disclosure: This clinical study was supported by Eli Lilly. Several authors on the study stated links to the pharmaceutical industry. For a full list of the authors’ information, see the original reference.
Ament M, day K, Stauffer VL et al. Effect of galcanezumab on migraine severity and symptoms in phase 3 studies in patients with episodic or chronic migraine. J headache. 2021; 22 (1): 6. doi: 10.1186 / s10194-021-01215-9