Erenumab of no benefit to patients with chronic cluster headache

Calcitonin gene-related peptide (CGRP) receptor blockade with erenumab does not appear to reduce the weekly frequency of cluster headache attacks, as shown in a study from Germany.

The study included 81 adult patients (mean age 48.9 years, 74.1 percent male) with chronic cluster headache (mean number of attacks per week 21.5) who had not achieved a sufficient response with standard prophylactic medications approved locally. Recruitment was stopped ahead of schedule due to an insufficient number of patients meeting the inclusion criteria.

The patients were randomly assigned to receive a loading dose of erenumab 280 mg subcutaneously (n=41) or matching placebo (n=40), followed by another dose of erenumab 140 mg subcutaneously or placebo 4 weeks later.

Researchers assessed the reduction in mean weekly cluster headache attacks from baseline over weeks 5 and 6 as the primary endpoint. Key secondary endpoints included 50-percent responder rates and changes in Patient Global Impression of Improvement (PGI-I) scores. Safety and tolerability were also evaluated.

The primary endpoint was not met, with the mean reduction in weekly attacks over weeks 5 and 6 not significantly different between the erenumab and placebo groups (−7.3 vs −5.9 attacks per week; group difference, −1.5, 95 percent credible interval [CrI], −5.7 to 2.8).

Likewise, the percentage of patients who achieved at least a 50-percent reduction in cluster headache attacks was comparable between the erenumab and placebo groups (31.7 percent vs 45.0 percent; odds ratio, 0.5, 95 percent CrI, 0.2–1.5). PGI-I scores were also similar between the two groups.

In terms of safety, adverse events (AEs) occurred more frequently among erenumab-treated patients than among those who received placebo (65.9 percent vs 42.5 percent). Most AEs were mild or moderate in intensity.