Abstract text (incl. figure legends and references)

QUESTION:

To evaluate the efficacy and safety of galcanezumab for refractory chronic cluster headache (RCCH) patients in clinical practice. RCCH patients usually fail to most of preventive treatments started on them. There"s a need for new drugs to improve their bad quality of life.

METHODS:

We prescribed galcanezumab 360 mg alternating with 240 mg per month in RCCH patients willing to participate in this exploratory study. All of them received at least a 6 month treatment period. They had tested all kind of preventive treatments, including botulinumtoxinA injections. No previous treatment was stopped, galcanezumab was started as add-on therapy. We analyse mean cluster headache attacks (CHA) per week reduction after treatment. Adverse events were also collected. Informed consent was obtained.

RESULTS:

7 patients (6 men / 1 woman) 23-59 years (mean 44,43) were included in the registry, all of them at least > 2 years of RCCH (mean 12,57 years (4-24). Most of them were smokers, just one with alcohol consumption. 3 of them continued with botulinumtoxinA injections each 3 months due to partial response. Mean CHA of 24,14 per week before treatment. 9,29 CHA per week after treatment; this means a reduction of 54,2 % in CHA per week (3,7 – 95 %). In most patients a significant reduction in intensity was found. 3 of them were high responders (reduction more than 75 %) and 3 no responders (25 % or less). No significant adverse events were found, the most usual: local dermal reactions in sites of punction (erythema, swallowing, pruritus)

CONCLUSIONS:

High doses of galcanezumab can be an option for RCCH patients. The treatment is safe and ameliorates at least half of patients in which we prescribed it. In this very difficult to treat population any benefit is welcome, so the use of galcanezumab should be tested in RCCH patients.