21st International Headache Congress, Seoul, Güney Kore, 14 - 17 Eylül 2023, cilt.43, ss.243
Objective: This real-word study aimed to investigate the
impact of galcanezumab on migraine outcome, sleep and
multidimensional patient-reported outcomes measures
(PROMs) in patients with episodic migraine (EM) and
chronic migraine (CM).
Methods: A total of 54 patients (mean SD age: 38.3
10.1 years; 90.7% were female) diagnosed with EM (n¼ 24)
or CM (n¼ 30) who received galcanezumab injection series
over a 3-month period were included in this single-center
real-word prospective cohort study. Galcanezumab was
administered at a loading dose (240 mg) at baseline visit,
and then at 120 mg dose on a monthly basis during 1st to
3rd month visits. Migraine outcome was evaluated based on
monthly headache days (MHDs), monthly migraine days
(MMDs) and headache severity. The sleep was assessed
by Pittsburgh Sleep Quality Index (PSQI), PROMs included
Migraine Disability Assessment Scale (MIDAS), Headache
Impact Test-6 (HIT-6), Allodynia Symptom Checklist
(ASC-12), SF-36 Health-related Quality of Life (HRQoL),
Beck Anxiety Inventory (BAI) and Beck Depression
Inventory (BDI).
Results: From baseline to 1st, 2nd and 3rd months, galcanezumab significantly improved median (IQR) MHDs,
MMDs, headache severity (p < 0.001). Total PSQI scores
were significantly decreased from baseline to 3rd month in
subgroups of patients with low anxiety at baseline
(p ¼ 0.002) and none/minimal depression (p ¼ 0.003) at
baseline. Total PSQI score (p < 0.001), sleep latency
(p ¼ 0.018), sleep disturbances (p ¼ 0.015) and daytime
dysfunction (p ¼ 0.003) in the overall population were
also significantly decreased. PROMs were significantly
improved from baseline to 1st, 2nd and 3rd months,
including MIDAS (p < 0.001), HIT-6 (p < 0.001 for each),
ACS-12 (p ¼ 0.005, p ¼ 0.017 and p ¼ 0.002), BAI
(p < 0.001 for each), BDI (p ¼ 0.048, p < 0.001 and
p < 0.001) and SF-36 HRQoL (p ranged 0.012 to <0.001).
Conclusion: Galcanezumab seems to be a promising and
effective agent for migraine prophylaxis in real life setting
of CM or EM, enabling rapid-onset improvements in
migraine outcome, sleep problems especially in patients
without comorbid depression and/or anxiety, and in multidimensional PROMs including HIT-6, MIDAS, MBSs, allodynia, HRQoL and negative emotional states.