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Emgality effective in migraine, other results vary

PHILADELPHIA — Emgality, an FDA-approved treatment for preventing migraines, was effective in chronic and episodic migraines but had varied results in other types of headache, according to studies presented at the American Headache Society Annual Scientific Meeting.

David Dodick, MD, of the Mayo Clinic, and colleagues reviewed data from 237 patients with chronic cluster headache who were randomly assigned to receive placebo or Emgality (galcanezumab, Lilly) 300 mg.

Patients used electronic diaries daily to record number of headache attacks, average pain severity, average headache attack duration and acute medication use.

Researchers found that galcanezumab was not superior to placebo in reducing weekly cluster headache attacks throughout the study period (–4.6 placebo vs. –5.4 galcanezumab; P = .334).

Emgality, an FDA-approved treatment for preventing migraines, was effective in chronic and episodic migraines but had varied results in other types of headache, according to studies presented at the American Headache Society Annual Scientific Meeting.

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“[Galcanezumab] 300 mg did not achieve its primary and key secondary endpoints in this [chronic cluster headache] prevention trial. The safety profile is consistent with that observed in patients with migraine and episodic cluster headache,” Dodick and colleagues wrote.

Results from other galcanezumab studies presented at the meeting include:

• A greater proportion of patients treated with galcanezumab (30.9%) shifted from a chronic to episodic state after 3 months of treatments than those who received placebo (19.7%); across a 12-month treatment period, 65.1% of treated patients shifted from chronic migraine to episodic migraine, 44.2% shifted to low frequency migraine and 21.5% shifted to very low frequency; 55% of patients shifted from low to episodic for at least 3 consecutive months and through their final visit.

• After comparing outcomes in 1,773 patients with episodic migraine and 1,113 patients with chronic migraine treated with galcanezumab, researchers found that headache frequency did not cause significant differences in treatment-emergent adverse outcomes. Researchers noted that episodic and chronic migraine had similar levels of adverse events despite typically higher disease burden in chronic migraine patients.

• 270 patients with episodic or chronic migraine were randomly assigned to receive galcanezumab 120 mg or 240 mg and completed migraine questionnaires. Based on changes in scores from the baseline, both treatment arms had improved functioning and reduced disability in addition to statistically significant changes from the baseline throughout the 12-month treatment phase.

• Patients with episodic cluster headache who received galcanezumab 300 mg used pooled acute medications less frequently than those who received placebo (mean difference = –5.52; 95% CI, –10.01 to –1.02) in the first 3 weeks of treatment; those who reported feeling “much better” on the Patients Global Impression of Improvement scale and had a median weekly chronic headache attack reduction of 43%, and were more often from the treatment group than the placebo group (OR = 2.6; 95% CI, 1.27-5.31).

Galcanezumab was approved by the FDA in 2018 as a monthly, self-administered treatment to prevent migraines in adults. – by Erin Michael

Reference:

Detke H, et al. Shift from chronic migraine status in a long-term phase 3 study of galcanezumab.

Dodick D, et al. Phase 3 placebo-controlled study of galcanezumab in patients with chronic cluster headache: results from 3-month double blind treatment.

McAllister P, et al. Patient functioning and disability among patients with migraine: evaluation of galcanezumab in a long-term, open label study.

Prasad S. Post-hoc outcomes from a phase 3 randomized, double-blind, placebo controlled study of galcanezumab in patients with episodic cluster headache.

Stauffer, V et al. Galcanezumab safetly/tolerability profile does not differ in patients with episodic or chronic migraine.

All presented at: American Headache Society Annual Scientific Meeting; July 11-14, 2019; Philadelphia.

Disclosures: Stauffer is an employee of Eli Lilly and company. Healio Primary Care was unable to confirm other authors’ relevant financial disclosures prior to publication.