Spain: In a new conducted by a group of researchers led by Miguel J. A. Láinez, it was shown that galcanezumab 300 mg monthly demonstrated an excellent tolerance and safety profile in individuals with chronic cluster headache (CH) who received therapy for up to 15 months. The findings of this study were published in Headache: The Journal of Head and Face Pain.
Chronic CH is a severely disabling condition with a large unmet medical need. As a result, this research was done with the goal of assessing the tolerance and safety of galcanezumab in patients with persistent CH for up to 15 months of therapy.
For this study, patients were randomly assigned to either placebo or galcanezumab (300 mg) monthly for 12 weeks, with a possible 52-week open-label extension and 16-week posttreatment follow-up (washout). This study is just the secondary analysis and long-term follow-up of an earlier clinical experiment. Patients who received galcanezumab at any point throughout the study were included in the safety analysis. Discontinuations, electrocardiograms (ECGs), Adverse events (AEs), laboratory values, vital signs, and suicidality assessments were among the outcomes.
The key findings are as follow:
1. A total of 233 individuals were given at least one dosage of galcanezumab. The average duration of exposure was 341 days.
2. Patients who received galcanezumab were primarily men, with a mean age of 44.9 (10.9) years. 185 individuals experienced treatment-emergent adverse events (TEAEs), 23 patients reported severe adverse events (SAEs), and 18 patients discontinued owing to AEs.
3. Three patients reported having SAE CH. Nasopharyngitis and injection site discomfort was the most prevalent TEAEs (>10%). TEAEs related to injection sites were reported by 27.5% of patients.
4. Injection site rash, injection site urticaria, and injection site hypersensitivity were all described as possible hypersensitivity reactions.
5. There has been a history of suicide ideation and conduct.
6. During the trial, 15 patients, seven of whom had a history of suicidal ideation, reported suicidal thoughts.
7. During the open-label extension, one patient attempted suicide but failed, and another attempted but failed during the washout.
8. There were no additional safety findings in laboratory data, vital signs, or ECGs as compared to the placebo-controlled treatment period.
In conclusion, the safety profile of galcanezumab in this research was consistent with that seen in migraine patients and in the episodic CH study. This research expanded previous migraine studies' findings to a higher dosage (300 mg) and a somewhat longer (15-month) period.
Reference:
Láinez MJA, Schoenen J, Stroud C, et al. Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment. Headache. 2022;62:65– 77. doi:10.1111/head.14234