Galcanezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide which is approved for the prevention of migraine.

CGAJ was a randomized, open-label study on episodic or chronic migraine (12-month open-label treatment phase). Patients aged 18-65 years were randomized 1:1 to subcutaneous GMB 120mg (with a loading dose of 240mg) or GMB 240mg given once monthly for 12 months. PRO measures included Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ; scale: 0-100) and Migraine Disability Assessment (MIDAS; scale: 0-270).

135 patients were randomized to each GMB dose group. 82.6% of patients were females (average age 42 years) with a predominant diagnosis of episodic migraine (78.8%). Mean (SD) baseline MSQ total scores: 53.85 (20.34) [GMB 120mg] and 53.69 (18.79) [GMB 240mg]. Overall least squares (LS) mean change±SE from baseline across the entire 12-month treatment phase in MSQ total scores: 28.27±1.16 (GMB 120mg) and 30.25±1.13 (GMB 240mg). Greatest improvement was observed in the RF-R domain, 31.55±1.20 (GMB 120mg) and 33.40±1.16 (GMB 240mg). For MIDAS, mean (SD) baseline total scores were 45.77 (42.06) [GMB 120mg] and 53.96 (61.24) [GMB 240mg], overall LS mean change ±SE from baseline across the entire 12-month treatment phase in total scores were -33.58±2.11 (GMB 120mg) and -32.67±2.04 (GMB 240mg). Within-group mean improvement from baseline on MSQ, MIDAS total scores, and all individual item/domain scores were statistically significant for both GMB groups at all time-points during the treatment phase (p<0.001).

Galcanezumab-treated patients had improved functioning and reduced disability with clinically meaningful and statistically significant changes from baseline overall across the entire treatment phase.