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

Authors

  • Anna Ambrosini Headache Clinic, IRCCS Neuromed
  • Emad Estemalik Headache Clinic, IRCCS Neuromed
  • Julio Pascual Headache Clinic, IRCCS Neuromed
  • Mallikarjuna Rettiganti Headache Clinic, IRCCS Neuromed
  • Chad Stroud Headache Clinic, IRCCS Neuromed
  • Kathleen Day Headache Clinic, IRCCS Neuromed
  • Janet Ford Headache Clinic, IRCCS Neuromed

DOI:

https://doi.org/10.48208/HeadacheMed.2020.Supplement.27

Keywords:

Acute Headache Medication Use, Health Care Resource Utilization, Treatment-Resistant Migraine

Abstract

Introduction
Acute headache medication use (AHM) and health care resource utilization (HCRU) in patients with protocol-defined 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.
Results
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-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 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-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.
Conclusions
GMB-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).

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Published

30/11/2020

How to Cite

1.
Ambrosini A, Estemalik E, Pascual J, Rettiganti M, Stroud C, Day K, Ford J. 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. HM [Internet]. 2020 Nov. 30 [cited 2021 Jun. 20];11(Supplement):27. Available from: https://headachemedicine.com.br/index.php/hm/article/view/112

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Abstracts