Annual indirect costs savings in patients with episodic or chronic migraine: a post-hoc analysis of phase 3 galcanezumab clinical trials in the United States

Figures & data

Table 1. Demographics and clinical characteristics – patients with episodic or chronic migraine.

Characteristics	EM				CM
	Overall	PBO	GMB	p-value	Overall	PBO	GMB	p-value
	(N = 805)	(N = 534)	(N = 271)		(N = 423)	(N = 279)	(N = 144)
Age, mean (SD), years	41.5 (11.6)	41.8 (11.4)	40.8 (11.9)	.2447	38.9 (11.8)	39.6 (12.1)	37.6 (11.3)	.0918
Female, n (%)	667 (82.9)	437 (81.8)	230 (84.9)	.3225	370 (87.5)	249 (89.2)	121 (84.0)	.1623
Monthly migraine headache days, mean (SD)	9.17 (3.0)	9.16 (3.0)	9.18 (3.0)	.9333	19.4 (4.3)	19.4 (4.5)	19.3 (3.7)	.7462
Employed, n (%)	–	–	–	–	308 (74.0)	202 (72.4)	106 (73.6)	.6629
Number of comorbidities, mean (SD)	4.2 (3.7)	4.2 (3.6)	4.3 (3.9)	.6118	5.2 (4.1)	5.3 (4.3)	4.9 (3.9)	.3480
Medication overuse, mean (SD)	–	–	–	–	256 (60.7)	168 (60.2)	88 (61.1)	.4481
Concurrent prophylaxis, mean (SD)	–	–	–	–	61 (14.4)	41 (14.7)	20 (13.9)	.8846
MSQ Total, mean (SD)	57.3 (16.2)	58.1 (16.1)	55.8 (16.5)	.0641	43.2 (17.3)	43.1 (17.2)	43.4 (17.5)	.8725
MSQ RFP	66.8 (18.7)	67.7 (18.2)	64.9 (19.4)	.0441	54.5 (20.6)	54.6 (20.0)	54.4 (21.7)	.9528
MSQ RFR	51.1 (15.3)	51.5 (15.0)	50.3 (15.8)	.3205	37.7 (16.8)	37.5 (17.0)	38.2 (16.6)	.6796
MIDAS Total, mean (SD)	34.1 (27.5)	33.4 (26.8)	35.5 (28.8)	.3083	65.7 (48.3)	68.9 (50.9)	59.7 (42.3)	.0633
MIDAS Q1	2.7 (4.0)	2.7 (3.8)	2.7 (4.3)	.9780	4.4 (8.0)	4.4 (8.7)	4.4 (6.5)	.9191
MIDAS Q2	7.5 (8.6)	7.6 (8.7)	7.4 (8.3)	.7676	14.5 (15.7)	15.6 (16.7)	12.5 (13.4)	.0526
MIDAS Q3	9.9 (9.2)	9.5 (8.7)	10.5 (10.3)	.1456	20.3 (18.8)	21.2 (20.0)	18.5 (16.1)	.1634
MIDAS Q4	8.8 (8.2)	8.5 (8.1)	9.3 (8.3)	.1886	15.0 (13.0)	15.6 (13.8)	13.9 (11.1)	.1929
MIDAS Q5	5.2 (6.4)	5.1 (5.7)	5.6 (7.5)	.3106	11.5 (14.5)	12.0 (14.6)	10.4 (14.2)	.2902

All values are presented as mean (SD), unless specified.

Abbreviations. CM, Chronic migraine; EM, Episodic migraine; GMB, Galcanezumab; MIDAS, Migraine Disability Assessment; PBO, Placebo; Q1, On how many days in the last 3 months did you miss work or school because of your headaches?; Q2, How many days in the last 3 months was your productivity at work or school reduced by half or more because of your headaches?; Q3, On how many days in the last 3 months did you not do household work (such as housework, home repairs and maintenance, shopping, caring for children and relatives) because of your headaches?; Q4, How many days in the last 3 months was your productivity in household work reduced by half of more because of your headaches?; Q5, On how many days in the last 3 months did you miss family, social, or leisure activities because of your headaches?; SD, Standard deviation.

Figure 1. Indirect cost savings with GMB and PBO from baseline. (a) Indirect cost savings in GMB among patients with EM; (b) Indirect cost savings in PBO among patients with EM; (c) Indirect cost saving in GMB among patients with CM; (d) Indirect cost saving in PBO among patients with CM. All data are presented as LSM change difference (95% CI). There are no 6 months data available for patients with CM. MMRM model: indirect cost change = treatment + study ID + month + treatment-by-month interaction + age + sex + number of comorbidities + baseline migraine headache day frequency category + baseline value + baseline value-by-month interaction. ANCOVA model: treatment + age + sex + number of comorbidities + baseline medication overuse (yes/no) + concomitant prophylaxis use (yes/no) + baseline value. Abbreviations. ANCOVA, Analysis of covariance; CI, Confidence interval; CM, Chronic migraine; EM, Episodic migraine; GMB, Galcanezumab; LSM, Least square mean; MMRM, Mixed model repeated measures; $, United States dollar. *** p < .001.

Figure 2. Indirect cost savings difference between GMB versus PBO. (a) Indirect cost savings at 3 months; (b) Indirect cost savings at 6 months. All data is presented as LSM (95% CI). There are no 6 months data available for patients with CM. MMRM model: indirect cost change = treatment + study ID + month + treatment-by-month interaction + age + sex + number of comorbidities + baseline migraine headache day frequency category + baseline value + baseline value-by-month interaction. ANCOVA model: treatment + age + sex + number of comorbidities + baseline medication overuse (yes/no) + concomitant prophylaxis use. Abbreviations. ANCOVA, Analysis of covariance; CI, Confidence interval; CM, Chronic migraine; EM, Episodic migraine; GMB, Galcanezumab; LSM, Least square mean; MMRM, Mixed model repeated measures; PBO, Placebo; $, United States dollar. * p < .05; ** p < .01; *** p < .001.

Figure 3. Indirect cost savings difference between GMB versus PBO (in employed patients). All data is presented as LSM (95% CI). There are no 6 months data available for patients with CM. MMRM model: indirect cost change = treatment + study ID + month + treatment-by-month interaction + age + sex + number of comorbidities + baseline migraine headache day frequency category + baseline value + baseline value-by-month interaction. Abbreviations. ANCOVA, Analysis of covariance; CI, Confidence interval; CM, Chronic migraine; EM, Episodic migraine; GMB, Galcanezumab; LSM, Least square mean; MMRM, Mixed model repeated measures; PBO, Placebo; $, United States dollar. *** p < .001.

Figure 4. Indirect cost savings difference between GMB – sensitivity analysis. (a) Indirect cost savings between GMB versus PBO at 3 months; (b) Indirect cost savings between GMB versus PBO at 6 months. All data is presented as LSM difference (95% CI). There are no 6 months data available for patients with CM. MMRM model: indirect cost change = treatment + study ID + month + treatment-by-month interaction + age + sex + number of comorbidities + baseline migraine headache day frequency category + baseline value + baseline value-by-month interaction. ANCOVA model: treatment + age + sex + number of comorbidities + baseline medication overuse (yes/no) + concomitant prophylaxis use. Abbreviations. ANCOVA, Analysis of covariance; CI, Confidence interval; CM, Chronic migraine; EM, Episodic migraine; GMB, Galcanezumab; LSM, Least square mean; MMRM, Mixed model repeated measures; PBO, Placebo; $, United States dollar. *p < .05; ***p < .001.