Galcanezumab Cuts Frequency of Disabling Cluster Headaches

Megan Brooks

July 12, 2019

A once-monthly subcutaneous injection of the calcitonin gene–related peptide (CGRP) antagonist galcanezumab (Emgality, Eli Lilly and Co) significantly cuts the frequency of episodic cluster headache attacks, results of a randomized controlled trial show.

The US Food and Drug Administration (FDA) approved galcanezumab for the prevention of migraine in adults in 2018 and for the treatment of episodic cluster headache in adults last month, as reported by Medscape Medical News.

Results of the study that led to approval in cluster headache were published online July 10 in the New England Journal of Medicine.

With this study, "clinicians should see a new, effective, safe treatment for episodic cluster headache that can substantially reduce attack frequency during bouts. The effect comes on quickly, and the new treatment is compatible with the current attack treatments," lead investigator Peter Goadsby, MD, PhD, from King's College London, United Kingdom, told Medscape Medical News.

Significantly Fewer Attacks

Cluster headache produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months. Cluster headache is often accompanied by bloodshot eyes, excessive tearing of the eyes, drooping of the eyelids, runny nose and/or nasal congestion, and facial sweating.

Some patients experience restlessness and agitation. Cluster headache attacks may strike several times a day and generally last from 15 minutes to 3 hours.

Galcanezumab was assessed for the treatment of episodic cluster headache in 106 adult patients who experienced at least one attack every other day, at least four total attacks, and no more than eight attacks daily during a baseline assessment. In addition, the patients had a history of cluster headache periods lasting at least 6 weeks.

Forty-nine patients were randomly assigned to receive galcanezumab 300 mg, and 57 patients were assigned to receive placebo, administered subcutaneously at baseline and at 1 month. The average number of cluster headache attacks per week in the baseline period was 17.8 in the galcanezumab arm and 17.3 in the placebo arm.

The primary endpoint was the mean change from baseline in the weekly frequency of cluster headache attacks from weeks 1 through 3 after receipt of the first dose.

During the 3-week period, patients who took galcanezumab experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared with 5.2 fewer attacks for patients who took placebo, a significant difference of 3.5 attacks per week with galcanezumab treatment (95% confidence interval, 0.2 – 6.7; P = .04).

The percentage of patients for whom there was a reduction of at least 50% in headache frequency at week 3 (secondary endpoint) was 71% in the galcanezumab group and 53% in the placebo group. There were no substantial between-group differences in the incidence of adverse events, except for injection-site pain, experienced by 8% of patients in the galcanezumab group vs none in the placebo group.

The researchers note that longer and larger trials are required to determine the durability and safety of galcanezumab. "A key question that remains," said Goadsby, "is how the termination of a bout using this therapy may impact timing to the next bout."

Welcome Option for Frustrated Patients

Commenting on the study for Medscape Medical News, Noah Rosen, MD, director, Northwell Health's Headache Center, Great Neck, New York, said that a number of his patients with cluster headaches had known about galcanezumab "well in advance of its approval, as there are very few choices for their rare and disabling condition.

"Many of them have grown frustrated with the options currently available but remain hopeful something will give them more relief. That being said, I have only started a few patients on this treatment, because it is only recently the appropriate dosing was available," said Rosen.

"While the cost remains high, it is a new, viable option that offers hope to a desperate population. There are few reasons not to consider the use of the new CGRP antibodies. The side effect profile is good, and there is evidence that they are cardiovascularly safe and a great option to avoid secondary medication side effects," said Rosen.

"Any new treatment for a cluster headache sufferer is anticipated and welcomed — one that looks as effective and safe as galcanezumab even more so," he added.

The study was funded by Eli Lilly. Goadsby has received grants and personal fees from Eli Lilly and other pharmaceutical companies. A complete list of author disclosures is available with the original article. Rosen has disclosed no relevant financial relationships.

N Engl J Med. Published online July 11, 2019. Abstract

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