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
2020 Headache Medicine  
IntroductionAcute headache medication use (AHM) and health care resource utilization (HCRU) in patients with protocol-defined treatment-resistant migraine treated with galcanezumab (GMB).Material and methodsIn 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
more » ... pen-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.ResultsOf 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-specific 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 first 3 months; change difference, -3.1 to -3.5, p<0.001 at each month during Months 1-3. During theOL, 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-specific 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-specific ER visits were <13 and hospitalizations were <2 per 100 person-years during the DB and OL.ConclusionsGMB-treated patients with treatment-resistant migraine had clinically meaningful reductions in days with AHM and numerically greater reductions in migraine-specific HCP. The abstract was previously presented at EHF (2020).
doi:10.48208/headachemed.2020.supplement.27 fatcat:kyqhtn6p4jcivaev435qknbs4q