Highlights from

AAN 2019

American Academy of Neurology annual meeting

Philadelphia, USA 4-10 May 2019

Galcanezumab reduces weekly cluster headache attack frequency

In a placebo-controlled trial, galcanezumab reduced the weekly episodic cluster headache attack frequency across Weeks 1-3 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.

Results from the double-blind treatment period of this trial were presented by Dr David Dodick (Mayo Clinic, Phoenix, USA). A total of 314 patients were screened, 104 were randomised and treated. Participants received subcutaneous galcanezumab 300 mg (n=49) or placebo (n=57) once monthly. The primary endpoint was the overall mean change from baseline in weekly cluster headache attack frequency across Weeks 1-3. The key secondary endpoint was the proportion of participants achieving a ≥50% reduction in weekly cluster headache attack frequency at Week 3.

There was a significant difference in the primary endpoint, with a weekly cluster headache attack frequency across Weeks 1-3 of -8.7 for galcanezumab vs -5.2 for placebo (P=0.036). The percentage of participants achieving ≥50% reduction in weekly cluster headache attack frequency at Week 3 was 76% vs 57% (P=0.04). Dr Dodick pointed out that the improvement of the PGI-I was significant after 4 weeks, but not anymore so after 8 weeks. “This likely reflects the typical spontaneous resolution of cyclic cluster headache after some weeks.”

Galcanezumab was generally well-tolerated. As Dr Dodick noted, “There was a low incidence of discontinuation due to adverse events, with no clinically meaningful differences between galcanezumab and placebo for safety parameters except for a higher incidence of injection site pain: 4 patients in the galcanezumab arm vs 0 in the placebo arm.” Dr Dodick could not say if any of the other available anti-CGRP antibodies could be effective in cluster headache.

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.