Long-term treatment with galcanezumab was found to be safe and effective for reducing the number of monthly migraine headache days in individuals with chronic or episodic migraine, according to a study published in BMC Neurology.
Galcanezumab is a humanized monoclonal antibody that binds selectively to the calcitonin gene-related peptide. A total of 270 participants (80% women; average age, 42 years; average number of migraine days per month at baseline, 10.6) who had been diagnosed with episodic or chronic migraine and had not been previously exposed to galcanezumab were enrolled in the study. Participants were randomly assigned to receive subcutaneous injections of galcanezumab at 120 mg or 240 mg (n=135 in each group) once monthly for 12 months. The study’s completion rate was 77.8%. A total of 3.7% of participants experienced a serious adverse event and 4.8% discontinued because of adverse events.
The following treatment-emergent adverse events occurred with a frequency ≥10% in either dose group: injection site pain, nasopharyngitis, upper respiratory tract infection, injection site reaction, back pain, and sinusitis.
The mean reduction in monthly migraine headache days after 12 months of treatment was 5.6 in participants receiving 120 mg galcanezumab and 6.5 in those taking 240 mg galcanezumab. Both groups reported improvements in level of functioning and headache-related disability.
“Although the study design was uncontrolled and open label, the totality of migraine headache reduction along with improvement in functioning and disability are considered to be clinically meaningful,” the researchers wrote.
This study was sponsored by Eli Lilly and Company. Eli Lilly and Company designed the study, collected, analyzed, and interpreted the data as well as drafted the manuscript.
Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18:188.