1. Efficacy and safety of galcanezumab as chronic cluster headache preventive treatment under real world conditions: Observational prospective study.
- Author
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Lamas Pérez R, Millán-Vázquez M, and González-Oria C
- Subjects
- Humans, Antibodies, Monoclonal therapeutic use, Prospective Studies, Treatment Outcome, Double-Blind Method, Cluster Headache drug therapy, Cluster Headache chemically induced, Migraine Disorders drug therapy, Antibodies, Monoclonal, Humanized
- Abstract
Background: Calcitonin gene-related peptide has shown to play a central role in cluster headache (CH) pathophysiology. A clinical trial with galcanezumab was carried out in chronic cluster headache (CCH) but did not meet its primay endpoint. However, its off-label use in patients with CCH refractory to other therapies could be considered. We aimed to asses the efficacy and safety of galcanezumab as CCH preventive treatment in a real-life setting., Methods: An observational study was conducted. Patients with CCH who received at least one dose of 240 mg of galcanezumab., Results: Twenty-one patients who tried a mean of 6.3 ± 1.9 preventive therapies, including onabotulinumtoxinA in 90.5%. At baseline, the median of frequency was 60 (37.5-105) monthly attacks with 10 (8.3-10) points in pain intensity (Numerical Rating Scale). After one month, the frequency decreased to 31 (10.5-45) ( p = 0.003) with 8.5 (8-9.5) intensity ( p = 0.007); 10 (47.6%) patients were 50% responders of whom four (19%) were 75% responders. Of the 15 patients with 3 months of follow-up, seven (46.6%) reduced their frequency by 50% and four (26.6%) by 75%, with 40 (10-60) monthly attacks ( p = 0.07) and pain intensity of 8 (5-10) ( p = 0.026). Some 52% patients experienced adverse events, mostly mild., Conclusions: In our cohort of refractory CCH, galcanezumab was effective in almost 50% of patients. This finding supports individual off-label treatment attempts., Competing Interests: Declaration of conflicting interestThe authors declare that there are no potential conflicts of interest with respect to the research, authorship and/or publication of this article.
- Published
- 2024
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