This real-life multicenter prospective cohort study [GARLIT] was performed to examine the overall efficacy of galcanezumab (humanized monoclonal antibody) in high-frequency episodic migraine (HFEM) and chronic migraine (CM) prophylaxis for 6 months.

Executed between November 2019 to January 2021, a total of 163 clinically eligible adult patients with HFEM and CM patients were enrolled. The initial loading dose of galcanezumab was 240 mg which was later set to 120 mg subcutaneous injection once-a-month. The variation in monthly migraine days (MMDs) and headache days (MHDs) in HFEM and CM patients after a period of 6 months was the primary endpoint. 

Out of 163 patients (mean age of 47.1 ± 11.7 years), 80.5% were women and 79.8% had CM. After 6 months, MMDs and MHDs decreased by 8 and 13 days in HFEM and CM patients. A considerable reduction in painkiller intake per month, numerical rating scale (NRS), Headache Impact Test-6 (HIT-6), and Migraine Disability Assessment (MIDAS) score was observed.

Ten patients (6.1%) discontinued due to inefficacy and were regarded as non-responders.  After 6 months, 76.5% and 63.5% responders (≥50% responder rates) were observed in the HFEM and CM group, respectively.

Among CM patients, these responders exhibited a lower body mass index and had failed a lesser number of preventive therapies compared to non-responders. About 77.2% of CM patients transformed to EM, and 82.0% stopped medication overuse (MO) after 6 months. Non-serious adverse events were reported in 10.3% of patients.

Substantial benefits of galcanezumab were noted in lessening the migraine attacks in real-life but not randomized controlled trials. This can be due to normal body weight and lesser unsuccessful preventive treatments being positively linked with its effectiveness in patients with chronic migraine.