Cluster headache and galcanezumab: the first real-world Brazilian study and an expert consensus on its use among other treatments.

Objective: To present the first Brazilian real-world results with galcanezumab and provide a consensus expert opinion on the prophylactic treatment of cluster headache (CH) in Brazil.

Methods: The first part of the study (real-world results) was observational, prospective, uncontrolled, and descriptive. A sample of 44 consecutive patients with episodic or chronic CH were evaluated and treated in a traditional tertiary clinic from March 2020 to June 2024. The second part (consensus expert opinion) consisted of a survey completed by ten Brazilian headache clinicians with at least 25 years of clinical experience, who published at least 15 headache papers and attended at least 15 national or international headache conferences.

Results: Forty-four patients (86.4% men, 13.6% women) were included. The average age was 45.9 ± 14.2 years. The diagnosis was made 27.3 ± 13.6 years after the onset of headache bouts. In 84.1% of the patients, CH was classified as episodic. Verapamil, lithium, or verapamil plus lithium were prescribed to respectively, 25%, 9.1%, and 6.8% of patients. Galcanezumab was prescribed to all and the majority (65.9%) used a dose of 300 mg once. There was a reduction in headache frequency of ≥ 50% at 3 weeks in 65.9% of patients for all doses of galcanezumab, and in 72.4% of those using galcanezumab 300 mg. Verapamil was recommended as a first-line treatment by 6 of 10 experts and a second-line treatment by the other 4 experts; galcanezumab was recommended as a first-line treatment by 4 of 10 experts and as a second-line treatment by 3 of 10 experts.

Conclusions: This study presented the first real-world data with galcanezumab in Brazilian patients with CH and showed a reduction in headache frequency in most patients. A survey of Brazilian experts not meant to represent the country's guidelines, favored galcanezumab as either the first or the second option in prophylaxis. Collectively, these results highlighted galcanezumab's promising efficacy as a new tool in CH patients.