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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.
As compared to the randomized controlled trials, the
use of galcanezumab was well-tolerated, safe, and appeared more effective in
real life.
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.
The Journal of Headache and Pain
Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study)
Fabrizio Vernieri et al.
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