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Comparative Study
. 2018 Feb 2:13:433-440.
doi: 10.2147/COPD.S144108. eCollection 2018.

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

Neil Barnes  1   2 , Takeo Ishii  3   4 , Nobuyuki Hizawa  5 , Dawn Midwinter  6 , Mark James  3 , Emma Hilton  1 , Paul W Jones  1   7
Affiliations
Comparative Study

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

Neil Barnes et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Background: Blood eosinophil measurements may help to guide physicians on the use of inhaled corticosteroids (ICS) for patients with chronic obstructive pulmonary disease (COPD). Emerging data suggest that COPD patients with higher blood eosinophil counts may be at higher risk of exacerbations and more likely to benefit from combined ICS/long-acting beta2-agonist (LABA) treatment than therapy with a LABA alone. This analysis describes the distribution of blood eosinophil count at baseline in Japanese COPD patients in comparison with non-Japanese COPD patients.

Methods: A post hoc analysis of eosinophil distribution by percentage and absolute cell count was performed across 12 Phase II-IV COPD clinical studies (seven Japanese studies [N=848 available absolute eosinophil counts] and five global studies [N=5,397 available eosinophil counts] that included 246 Japanese patients resident in Japan with available counts). Blood eosinophil distributions were assessed at baseline, before blinded treatment assignment.

Findings: Among Japanese patients, the median (interquartile range) absolute eosinophil count was 170 cells/mm3 (100-280 cells/mm3). Overall, 612/1,094 Japanese patients (56%) had an absolute eosinophil count ≥150 cells/mm3 and 902/1,304 Japanese patients (69%) had a percentage eosinophil ≥2%. Among non-Japanese patients, these values were 160 (100-250) cells/mm3, 2,842/5,151 patients (55%), and 2,937/5,155 patients (57%), respectively. The eosinophil distribution among Japanese patients was similar to that among non-Japanese patients. Within multi-country studies with similar inclusion criteria, the eosinophil count was numerically lower in Japanese compared with non-Japanese patients (median 120 vs 160 cells/mm3).

Interpretation: The eosinophil distribution in Japanese patients seems comparable to that of non-Japanese patients; although within multi-country studies, there was a slightly lower median eosinophil count for Japanese patients compared with non-Japanese patients. These findings suggest that blood eosinophil data from global studies are of relevance in Japan.

Keywords: COPD; Japan; blood eosinophil count; percentage blood eosinophil.

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Conflict of interest statement

Disclosure All authors, except NH, are full-time employees of Glaxo SmithKline and hold GlaxoSmithKline shares. NH declares research grants to his department from GlaxoSmithKline, as well as consulting fees from GlaxoSmithKline and other pharmaceutical companies. The authors report no other conflicts of interest in this work.

Figures

Figure 1
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 (NCT01702363), DB2115362 (NCT01376388), HZC114156 (NCT01192191), SCO100646 (NCT00269126), SCO100648 (NCT00269087), and SCO116571 (NCT01607398). The absolute eosinophil values were not available for the Japan-only study, SCO116717 (NCT01762800). Multi-country studies: AC4115408 (NCT01387230), DB2113361 (NCT01313637), DB2113373 (NCT01313650), HZC112206 (NCT01053988), and HZC112207 (NCT01054885).
Figure 2
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 (NCT00269126), SCO100648 (NCT00269087), and SCO116571 (NCT01607398), subjects in full analysis set population are included. (B) Subjects with eosinophil values >14% are grouped together in the >14 bar. For studies SCO100646 (NCT00269126), SCO100648 (NCT00269087), and SCO116571 (NCT01607398), subjects in full analysis set population are included. (B) Subjects with eosinophil values >14% are grouped together in the >14 bar. For studies SCO100646 (NCT00269126), SCO100648 (NCT00269087), and SCO116571 (NCT01607398), subjects in the full analysis set population are included. For study SCO116717 (NCT01762800), subjects in the modified ITT population are included. Abbreviations: COPD, chronic obstructive pulmonary disease; ITT, intention-to-treat.
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