Reductions in acute medication use and healthcare resource utilization in patients with chronic migraine: a secondary analysis of a phase 3, randomized, double-blind, placebo-controlled study of galcanezumab with open-label extension (REGAIN)

Figures & data

Table 1. Baseline demographics and disease burden.

	Placebo	Galcanezumab 120 mg	Galcanezumab 240 mg
	N = 558	N = 278	N = 277
Age (years), mean (SD)	41.6 (12.1)	39.7 (11.9)*	41.1 (12.4)
Gender (female), n (%)	483 (86.6)	237 (85.3)	226 (81.6)
Race (white), n (%)	432 (77.4)	223 (80.2)	224 (81.2)
Duration of migraine illness (years), mean (SD)	21.9 (12.9)	20.4 (12.7)	20.1 (12.7)*
Number of monthly migraine headache days, mean (SD)	19.6 (4.6)	19.4 (4.3)	19.2 (4.6)
Migraine headache days with acute medication use, mean (SD)	15.5 (6.6)	15.1 (6.3)	14.5 (6.3)*
Medication overuse for migraine, n (%)	353 (63.4)	178 (64.3)	177 (64.1)

SD, standard deviation.

*p < .05 compared to the placebo group.

Figure 1. Mean change from baseline in the number of migraine headache days with acute medication use. Abbreviations: GMB, galcanezumab; LS, least squares; OLE, open-label extension; SE, standard error. *p < .05 vs previous placebo. ***p < .001 vs placebo.

Figure 2. Acute medication overuse by treatment group. Abbreviations: GMB, galcanezumab; OLE, open-label extension. ***For Month 1, Month 2, and Month 3 (Double-blind period), galcanezumab rates vs placebo were statistically significantly lower (p < .001).

Figure 3. Migraine-specific healthcare resource utilization as count of patients with at least 1 visit (%) during treatment period. (a) Healthcare Professional Visits; (b) Emergency Room Visits; (c) Hospital Admissions. Abbreviations: GMB, galcanezumab; OLE, open-label extension period. ^aThe reported baseline value is the collected baseline value (previous 6 months) divided by 2.

Table 2. Migraine-specific healthcare resource utilization rates per 100 patient-years^a.

Event	Double-blind placebo/ Galcanezumab OLE			Double-blind galcanezumab 120 mg/ Galcanezumab OLE			Double-blind galcanezumab 240 mg/ Galcanezumab OLE
	n = 533^b			n = 269^b			n = 271^b
	Baseline	Double-blind	OLE	Baseline	Double-blind	OLE	Baseline	Double-blind	OLE
Emergency room visits	21.01	13.86	4.48**	19.33	15.29	4.85	25.09	15.00	10.62
% reduction from baseline		34%	79%		21%	75%		40%	58%
Admissions to hospital	1.50	0	1.19	1.49	0	0	0.74	0	0
% reduction from baseline		100%	21%		100%	100%		100%	100%
Overnight hospital stays	4.88	0	2.98	2.97	0	0	2.95	0	0
% reduction from baseline		100%	39%		100%	100%		100%	100%
Healthcare professional visits	110.69	44.64***	29.25***	102.60	29.04***	33.96***	143.17	36.00***	66.11***
% reduction from baseline		60%	74%		72%	67%		75%	54%

Abbreviation: OLE, open-label extension.

^aRefers to events per 100 patient-years based on data from the 6 months prior to randomization (Baseline), 3-month double-blind treatment period (Double-blind period), and 9-month OLE treatment period (OLE period).

^bn, number of randomized patients who have non-missing baseline value and at least 1 non-missing postbaseline value.

**p < .01 for differences within treatment group from baseline.

***p < .0001 for differences within treatment group from baseline; no statistically significant differences were observed for each galcanezumab dose compared to placebo for the double-blind and OLE treatment periods.

Table

Name	Location	Role	Contribution
Joshua Tobin	21st Century Neurology, Phoenix, AZ, USA	Author	Contributed to creating and revising the manuscript for content; data collection
Shivang Joshi	University of Buffalo School of Pharmacy, Buffalo, NY, USA	Author	Contributed to creating and revising the manuscript for content; data collection
Janet H. Ford	Eli Lilly and Company, Indianapolis, USA	Author	Contributed to the study design, interpretation of the data, writing of the initial draft of the manuscript, and revising the manuscript for content
Russell Nichols	Eli Lilly and Company, Indianapolis	Author	Contributed to creating and revising the manuscript for content
Shonda A. Foster	Eli Lilly and Company, Indianapolis	Author	Contributed to creating and revising the manuscript for content
Dustin Ruff	Eli Lilly and Company, Indianapolis	Author	Contributed to creating and revising the manuscript for content
Holland C. Detke	Eli Lilly and Company, Indianapolis	Author	Contributed to the study design, interpretation of the data, creating and revising the manuscript for content
Sheena K. Aurora	Eli Lilly and Company, Indianapolis	Author	Contributed to creating and revising the manuscript for content

Data sharing statement

Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the United States and European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.