Galcanezumab May Reduce Severity and Symptoms of Migraine

In addition to reducing the frequency of migraine headache days, treatment with galcanezumab (Emgality; Eli Lilly) may also potentially decrease disabling non-pain symptoms on days when migraine is present, according to the results of a recent study.

The study, published in The Journal of Headache and Pain, examined the effect of galcanezumab on the severity and symptoms of migraine. For the study, the investigators analyzed data from 3 randomized clinical trials, including 2 episodic trials and 1 chronic trial. Galcanezumab has previously demonstrated a significant reduction in monthly migraine headache days compared with placebo.

The episodic migraine trials were 6-month, double-blind studies involving patients with episodic migraine, defined as 4 to 14 monthly migraine headache days. The chronic migraine trial was a 3-month, double-blind study including patients with chronic migraine (≥15 headache days per month, where ≥8 met criteria for migraine).

In the studies, adult patients were randomized to placebo or galcanezumab 120 mg with a 240-mg loading dose or 240 mg. Patients documented headache characteristics, duration, severity, and presence of associated symptoms with each headache. The investigators analyzed 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 included the number of moderate-to-severe monthly migraine days, number of severe migraine headache days, and mean severity of remaining migraine headache days. Investigators also reported on the 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.

Overall, the results demonstrated that galcanezumab was superior to placebo in reducing the frequency of migraine headache days with associated symptoms of migraine in both the episodic and chronic migraine studies. Both the 120 and 240 mg doses of galcanezumab were superior to placebo.

Treatment with galcanezumab also reduced the frequency of migraine headache days with aura in the episodic migraine studies. Additionally, investigators reported 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 demonstrated superiority in reducing the number of monthly moderate-to-severe migraine headache days and the overall and monthly severe migraine headache days.

“Since migraine-associated symptoms such as nausea, vomiting, and photophobia result in greater migraine-associated disability and disease burden, it is important to reduce the number of migraine headache days with symptoms,” the investigators wrote in the study. “In addition to the absolute reduction in number of migraine headache days with symptoms, patients would also benefit from fewer symptoms on days with headache.”

Migraine symptoms such as nausea, photophobia, and phonophobia can cause significant disease burden and individuals with migraine also self-report problems with taking acute and/or preventive oral migraine medications due to nausea and vomiting, according to the study. Addressing these associated symptoms is especially important for reducing migraine-associated disability and burden of migraine.

Reference

1. Ament M, Day K, Stauffer VL, et al. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. The Journal of Headache and Pain. 2021.https://doi.org/10.1186/s10194-021-01215-9