Galcanezumab reduces cluster headache frequency

In a placebo-controlled trial, the anti-calcitonin gene-related peptide antibody galcanezumab reduced the weekly episodic cluster headache attack frequency from week 1 to 3, and resulted in a greater percentage achieving a reduction in the weekly cluster headache attack frequency at week 3 of at least 50%. The safety profile of galcanezumab was similar to that seen previously in patients with episodic or chronic migraine [1].

Dr David Dodick (Mayo Clinic, Phoenix, USA) stressed that there is underrecognition of cluster headache and a high rate of misdiagnosis that delays the correct diagnosis an average of 5 to 7 years. “Effective acute treatments are underused, and there are no approved medications for prevention.” Presenting results from the double-blind treatment period of this trial, Dr Dodick said participants were randomised to subcutaneous galcanezumab 300 mg (n=49) or placebo (n=57) once monthly. The primary endpoint was the overall mean change from baseline in weekly attack frequency across weeks 1 to 3. A significant difference was found: -8.7 for galcanezumab versus -5.2 for placebo (P=0.036). The key secondary endpoint, the proportion achieving a ≥50% reduction in weekly attack frequency at week 3, was also significantly higher (76% vs 57%; P=0.04).

Dr Dodick pointed out that the Patient Global Impression of Improvement (PGI-I) was significantly better after 4 weeks in the active treatment group, but not after 8 weeks. “This likely reflects the typical spontaneous resolution of cyclic cluster headache after some weeks.” Galcanezumab was generally well-tolerated. There was a low incidence of discontinuation due to adverse events, with no clinically meaningful differences between galcanezumab and placebo in safety parameters except for a higher incidence of injection site pain (4 patients in the galcanezumab arm versus 0 in the placebo arm). He could not say if any of the other available anti-calcitonin gene-related peptide antibodies may be effective in cluster headache.

1. Bardos JN, et al. AAN 2019, Plen02.004.



Posted on 30 July 201915 March 2021