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Galcanezumab effectively reduced weekly cluster headache attacks

SAN FRANCISCO — Galcanezumab significantly reduced cluster headache attacks within the first 3 weeks of therapy, according to phase 3 study results presented at the American Headache Society Annual Scientific Meeting.

Galcanezumab also demonstrated a similar safety profile to placebo except for injection site pain, according to the results.

“This was uncharted, because cluster headache has not really been studied in a double-blind, placebo-controlled fashion for years,” Sheena K. Aurora, MD, a medical fellow and global launch leader at Eli Lilly, and an adjunct clinical associate professor of anesthesiology, perioperative and pain medicine at Stanford Medicine, told Healio Internal Medicine. “The nearest study had 15 active patients. This program aimed to look at episodic and chronic cluster headache. We went into this without a phase 2 [study], because we thought that there was an urgency in finding a treatment for this disease because there’s such a high unmet need.”

Aurora and colleagues conducted a double-blind, placebo-controlled phase 3 study of 106 patients to assess the efficacy and safety of galcanezumab (Eli Lilly) 300 mg delivered subcutaneously. The study group comprised 49 patients (median age, 47 years; 84% male); the placebo group included 57 (median age, 45 years; 82% male).

Patients placed in the study group reported a median of 17.8 weekly cluster headache attacks at baseline, while patients in the placebo group reported a median 17.3 weekly attacks at baseline.

Overall mean change from baseline in weekly cluster headache attack frequency across weeks 1 to 3 served as the primary endpoint.

Secondary endpoints included proportion of patients with a 50% or greater reduction from baseline in the weekly frequency of cluster headache attacks at week 3 and mean change in the weekly cluster headache attack frequency from baseline to each weekly interval through week 8.

During the first 3 weeks, the number of cluster headache attacks that were reduced from baseline was 8.7 for galcanezumab compared with 5.2 on placebo (P = .036).

A 50% or greater reduction in weekly cluster head attack frequency was achieved by 76% (n = 46) of patients receiving galcanezumab compared with 57% of patients in the placebo group (n = 53)(P = .04).

Forty-three percent of patients who received galcanezumab reported a treatment-related adverse event, compared with 33% of patients who received placebo.

The most commonly reported adverse events for patients who received galcanezumab was injection site pain (n = 4) and nasopharyngitis (n = 3).

Two patients discontinued study treatment due to adverse events.

Aurora said that patients have remained in a long-term access program to continue to receive galcanezumab monthly. She said the researchers have yet to review data from that group as the study is still ongoing.

Aurora said that the results are promising for patients who have recently felt relegated to a lack of treatment advances for cluster headaches.

“All the treatment advances have been in other headache conditions,” she said. “Not that those aren’t warranted, but cluster headache is still a very devastating disease. We now have something that has demonstrated to be effective without a lot of burden.” – by Ryan McDonald

Reference:

Martinez JM, et al. IOR-03LB. Presented at: American Headache Society Annual Scientific Meeting; June 28-July 1, 2018; San Francisco.

Disclosures: Aurora is an employee of Eli Lilly.