Headache Medicine
ISSN 2178-7468
-ISSN 2763-6178
p. 27
October 2020.
DOI: 10.48208/HeadacheMed.2020.Supplement.27
Ambrosini, A.; Estemalik, E.; Pascual, J.; Rettiganti, M.; Stroud, C.; Day, K.; Ford, J.
Headache Medicine
Effects of galcanezumab on acute medication use and health care resource
utilization in treatment-resistant migraine: results from randomized, double blind,
placebo-controlled clinical trial, conquer
Anna Ambrosini, Emad Estemalik, Julio Pascual, Mallikarjuna Rettiganti, Chad Stroud, Kathleen Day, Janet Ford
Headache Clinic, IRCCS Neuromed
Acute headache medication use (AHM) and health care resource utilization (HCRU) in patients with protocol-dened treatment-resistant
migraine treated with galcanezumab (GMB).
Material and methods
In the 3-month double-blind (DB) study phase, patients with episodic or chronic migraine and 2-4 migraine preventive category failures
due to lack of effectiveness or safety/tolerability, received GMB 120 mg/month (following initial 240 mg loading dose) or placebo
(PBO); an optional 3-month open-label (OL) GMB treatment followed. AHM was self-reported daily with eDiary and paper-forms. HCRU
was reported at baseline (retrospectively for previous 6 months) and at monthly visits.
Of the 462 patients (GMB n=232, PBO n=230), baseline mean (±SD) days/month of AHM was 12.3 (±6.0); 44.8% had AHM overuse.
The percentage of patients reporting migraine-specic HCRU at baseline in the GMB and PBO groups were respectively: 40% and 50%
healthcare-professional visits (HCP), 6% and 5% emergency-room (ER) visits, and in each, 2% hospitalizations. LS mean reductions from
baseline in the mean number of days/month with AHM in the DB was greater for the GMB group (3.9 to 4.5 days) compared to PBO
(0.4 to 1.0 days) in each of the rst 3 months; change difference, -3.1 to -3.5, p<0.001 at each month during Months 1-3. During the
OL, reductions from baseline ranged -4.7 to -5.3 days; prior PBO group reductions were comparable to that observed in GMB. During
the DB, reductions from baseline of migraine-specic HCP (per 100 person- years) were numerically greater with GMB than PBO (-215.5
vs -155.3); during OL, the prior PBO group reductions (-212.9) were similar to GMB (-222.6). For both groups, migraine-specic ER visits
were <13 and hospitalizations were <2 per 100 person-years during the DB and OL.
GMB-treated patients with treatment-resistant migraine had clinically meaningful reductions in days with AHM and numerically greater
reductions in migraine-specic HCP. The abstract was previously presented at EHF (2020).
Acute Headache Medication Use, Health Care Resource Utilization, Treatment-Resistant Migraine