OBJECTIVES: Galcanezumab is a humanized monoclonal antibody against calcitonin gene-related peptide under development for migraine prevention. Changes in healthcare resource utilization (HCRU) and acute medication use from an open-label study of galcanezumab in patients with episodic/chronic migraine were evaluated. To further interpret the effects of galcanezumab, results from the double-blind period of a placebo-controlled study in patients with chronic migraine were assessed.

METHODS: CGAJ (NCT02614287) was a Phase 3, randomized, open-label study in patients with episodic/chronic migraine with a 12-month treatment period (treatment arms: galcanezumab-120mg/month and -240mg/month). CGAI (REGAIN, NCT02614261) was a Phase 3, randomized clinical trial in patients with chronic migraine comprising a three-month double-blind period (treatment arms: placebo, galcanezumab-120mg/month and -240mg/month). For both trials, at baseline, patients reported HCRU for the previous 6 months and during treatment period, at each monthly visit. Acute headache medication use was self-reported at monthly visits (CGAJ) or in an electronic daily diary (CGAI).

RESULTS: In CGAJ, treatment with galcanezumab resulted in within-group reductions from baseline in migraine-specific HCRU (per 100 person-years): healthcare professional visits (173.4 to 59.6), emergency room visits (20.2 to 4.7), admissions to hospital (3.7 to 0.4) and overnight hospital stays (16.4 to 0). Significant within-group reductions from baseline in mean number of days/month with acute headache medication use were observed (overall change: -5.1 for galcanezumab-120mg or -240mg; p<0.001). In CGAI, reductions in healthcare professional visits during the three-month blinded period were numerically greater (not statistically significant) with galcanezumab (122.8 to 32.6) versus placebo (110.7 to 44.6). Overall mean reductions in number of days/month with acute headache medication use were significantly larger with galcanezumab treatment compared to placebo (p<0.001).

CONCLUSIONS: Results from Phase 3 studies suggest that treatment with galcanezumab results in clinically meaningful reductions, particularly over a year, in migraine-specific HCRU and acute headache medication use.