Abstract
BackgroundGalcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days compared with placebo. Here, we analyze data from 3 randomized clinical trials (2 episodic trials [EVOLVE-1, EVOLVE-2] and 1 chronic trial [REGAIN]), to examine if galcanezumab also alleviates the severity and symptoms of migraine.MethodsThe episodic migraine trials were 6-month, double-blind studies in patients with episodic migraine (4–14 monthly migraine headache days). The chronic migraine trial was a 3-month, double-blind study in patients with chronic migraine (≥ 15 headache days per month, where ≥ 8 met criteria for migraine). Patients (18–65 years) were randomized to placebo or galcanezumab 120 mg with a 240-mg loading dose or 240 mg. Patients recorded headache characteristics, duration, severity, and presence of associated symptoms with each headache. The outcomes analyzed were changes from baseline in number of monthly migraine headache days with nausea and/or vomiting, photophobia and phonophobia, aura, and prodromal symptoms other than aura. Additional outcomes analyzed included the number of moderate-to-severe monthly migraine headache days, number of severe migraine headache days, and mean severity of remaining migraine headache days. Change from baseline in the proportion of days with nausea and/or vomiting and the proportion of days with photophobia and phonophobia among the remaining monthly migraine headache days were also analyzed.ResultsGalcanezumab was superior to placebo in reducing the frequency of migraine headache days with associated symptoms of migraine such as nausea and/or vomiting, photophobia and phonophobia, and prodromal symptoms. Galcanezumab reduced the frequency of migraine headache days with aura in the episodic migraine studies. There was a significant reduction in the proportion of remaining migraine headache days with nausea and/or vomiting for the episodic and chronic migraine studies, and with photophobia and phonophobia for the episodic migraine studies. Galcanezumab was superior to placebo in reducing the number of monthly moderate-to-severe migraine headache days and the overall and monthly severe migraine headache days.ConclusionsGalcanezumab reduces the frequency of migraine headache days and can alleviate potentially disabling non-pain symptoms on days when migraine is present in patients with episodic or chronic migraine.Trial registrationNCT, NCT02614183 (EVOLVE-1), registered 25 November 2015; NCT, NCT02614196, (EVOLVE-2), registered 25 November 2015; NCT, NCT02614261 (REGAIN), registered 25 November 2015.
Highlights
Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days compared with placebo
We examine the efficacy of galcanezumab on the severity and symptoms of migraine in patients with episodic and chronic migraine, and we assess if galcanezumab leads to reductions in non-pain symptoms associated with migraine such as nausea and vomiting, phonophobia and photophobia, aura, and prodromal symptoms
Baseline characteristics Overall, baseline demographic and disease characteristics were generally consistent between the groups in the episodic migraine studies and between the groups in the chronic migraine study with the exception of migraine headache day frequency and related symptoms (Table 1)
Summary
Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days compared with placebo. Migraine is primarily defined by its most prominent symptom which is a unilateral, moderate-to-severe, pulsating headache lasting from 4 to 72 hours and aggravated by routine physical activity usually accompanied by nausea and/or vomiting or photophobia and phonophobia [5]. Many patients experience a prodromal or premonitory phase that may begin hours or days before the headache phase of a migraine attack [5] and some patients experience a postdromal phase following headache resolution. These premonitory symptoms may include fatigue, difficulty concentrating, neck stiffness, sensitivity to light and/or sound, nausea, blurred vision, yawning, and pallor [5,6,7,8]. 20–30 % of patients may experience aura (commonly manifested as visual disturbances) usually beginning approximately 60 minutes before the headache phase of a migraine attack [9, 10]
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