The distribution of blood eosinophil levels in a Japanese COPD clinical trial database and in the rest of the world

Figures & data

Table 1 Patient demographics

Characteristics	All studies, Japanese patients (N=1,094)	Multi-country studies, non-Japanese patients (N=5,151)	Multi-country studies, Japanese patients (N=246)
Age (years), mean (SD)	70 (7.4)	62 (8.7)	69 (7.4)
Age (years), n (%)
<65	257 (23)	3,029 (59)	68 (28)
≥65	837 (77)	2,122 (41)	178 (72)
Male, n (%)	1,037 (95)	3,454 (67)	234 (95)
GOLD stage, n (%)
n	1,042	5,128	245
I: FEV1 ≥80% predicted	1 (<1)	2 (<1)	0
II: 50% ≤ FEV1,80% predicted	586 (56)	2,370 (46)	141 (58)
III: 30% ≤ FEV1,50% predicted	407 (39)	2,263 (44)	83 (34)
IV: FEV1,30% predicted	48 (5)	493 (10)	21 (9)
SGRQ total score
n	156a	2,904a	156a
Mean (SD)	39.4 (15.64)	48.9 (17.66)	39.4 (15.64)
Number of patients with COPD exacerbations managed without oral/systemic corticosteroids and/or antibiotics (not involving hospitalization) in the past 12 months, n (%)
n	537b	2,140c	89d
0	523 (97)	1,900 (89)	86 (97)
1	14 (3)	209 (10)	3 (3)
2	0	25 (1)	0
>2	0	6 (<1)	0
Number of patients with COPD exacerbations requiring oral/systemic corticosteroids and/or antibiotics (not involving hospitalization) in the past 12 months, n (%)
n	694e	5,151	246
0	612 (88)	3,822 (74)	217 (88)
1	59 (9)	1,034 (20)	20 (8)
2	15 (2)	199 (4)	4 (2)
>2	8 (1)	96 (2)	5 (2)
Number of patients with COPD exacerbations requiring hospitalization in the past 12 months, n (%)
n	1,043f	5,151	246
0	1,008 (97)	4,664 (91)	239 (97)
1	33 (3)	437 (8)	7 (3)
2	2 (<1)	43 (<1)	0
>2	0	7 (<1)	0

Notes:

a Available for studies AC4115408 (NCT1387230), DB2113361 (NCT1313637), and DB2113373 (NCT1313650) only.

b Available for studies AC4115361 (NCT1702363), DB2115362 (NCT1376388), HZC112206 (NCT1053988), HZC112207 (NCT1054885), and HZC114156 (NCT1192191) only.

c Available for studies HZC112206 (NCT1053988), and HZC112207 (NCT1054885) only.

d Not available for studies AC4115408 (NCT1387230), DB2113361 (NCT1313637), and DB2113373 (NCT1313650).

e Not available for studies SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398).

f Not available for study SCO116571 (NCT1607398).

Abbreviations: SD, standard deviation; GOLD, Global Initiative for Chronic Obstructive Lung Disease; FEV₁, forced expiratory volume in 1 second; SGRQ, St George’s Respiratory Questionnaire; COPD, chronic obstructive pulmonary disease.

Table 2 Summary of absolute and percentage blood eosinophil count across the five patient groups

	All studies, Japanese patients (n=1,094)	Japan-only studies (n=848)	Multi-country studies (n=5,397)	Multi-country studies, Japanese patients (n=246)	Multi-country studies, non-Japanese patients (n=5,151)
Absolute blood eosinophil count, cells/mm^3
Mean (SD)a	216.9 (192.09)	228.6 (191.70)	207.0 (207.53)	176.7 (188.34)	208.4 (208.31)
Median (IQR)a	170 (100–280)	180 (110–281)	160 (90–250)	120 (50–260)	160 (100–250)
<150 cells/mm^3 (n [%])	482 (44.1)b	343 (40.4)c	2,448 (45.4)d	139 (56.5)d	2,309 (44.8)d
≥150 cells/mm^3 (n [%])	612 (55.9)b	505 (59.6)c	2,949 (54.6)d	107 (43.5)d	2,842 (55.2)d
Percentage blood eosinophil count
	(n=1,304)	(n=1,058)	(n=5,401)	(n=246)	(n=5,155)
<2% eosinophils (n [%])	402 (30.8)b	274 (25.9)c	2,346 (43.4)d	128 (52.0)d	2,218 (43.0)d
≥2% eosinophils (n [%])	902 (69.2)b	784 (74.1)c	3,055 (56.6)d	118 (48.0)d	2,937 (57.0)d

Notes:

a Japan-only studies: AC4115361 (NCT1702363), DB2115362 (NCT1376388), HZC114156 (NCT1192191), SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398). Study SCO116717 (NCT1762800) is Japan-only but absolute eosinophil values are not available. Multi-country studies: AC4115408 (NCT1387230), DB2113361 (NCT1313637,) DB2113373 (NCT1313650), HZC112206 (NCT1053988), and HZC112207 (NCT1054885). All studies: Japan-only studies and Multi-country studies combined.

b Studies AC4115408 (NCT1387230), AC4115361 (NCT1702363), DB2113361 (NCT1313637), DB2113373 (NCT1313650), DB2115362 (NCT1376388), HZC112206 (NCT1053988), HZC112207 (NCT1054885), HZC114156 (NCT1192191), SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398) are included. For studies SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398) subjects in FAS population are included. For percentage eosinophils, study SCO116717 (NCT1762800) was also included.

c Studies AC4115361 (NCT1702363), DB2115362 (NCT1376388), HZC114156 (NCT1192191), SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398) are included. For studies SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398) subjects in the full analysis set population are included. For percentage eosinophils, study SCO116717 (NCT1762800) was also included.

d Studies AC4115408 (NCT1387230), DB2113361 (NCT1313637), DB2113373 (NCT1313650), HZC112206 (NCT1053988), and HZC112207 (NCT1054885). are included.

Abbreviations: IQR, interquartile range; FAS, full analysis set; SD, standard deviation.

Figure 1 Japan-specific data distribution for absolute blood eosinophil count compared with other groups.

Notes: An empirical cumulative distribution function plot was produced to evaluate the distribution of absolute blood eosinophil count data, with a line for each of the five patient groups overlaid into a single plot. The lines show the cumulative probability for subjects in the specified group. Japan only studies: AC4115361 (NCT1702363), DB2115362 (NCT1376388), HZC114156 (NCT1192191), SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398). The absolute eosinophil values were not available for the Japan-only study, SCO116717 (NCT1762800). Multi-country studies: AC4115408 (NCT1387230), DB2113361 (NCT1313637), DB2113373 (NCT1313650), HZC112206 (NCT1053988), and HZC112207 (NCT1054885).

Figure 2 Distribution of (A) absolute blood eosinophil count and (B) percentage blood eosinophils among Japanese patients with COPD.

Notes: (A) Subjects with eosinophil values >800 cells/mm³ are grouped together in the >800 bar. For studies SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398), subjects in full analysis set population are included. (B) Subjects with eosinophil values >14% are grouped together in the >14 bar. For studies SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398), subjects in full analysis set population are included. (B) Subjects with eosinophil values >14% are grouped together in the >14 bar. For studies SCO100646 (NCT0269126), SCO100648 (NCT0269087), and SCO116571 (NCT1607398), subjects in the full analysis set population are included. For study SCO116717 (NCT1762800), subjects in the modified ITT population are included.
Abbreviations: COPD, chronic obstructive pulmonary disease; ITT, intention-to-treat.