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Table 2 Moderate or severe exacerbations: EOS count subgroups by exacerbation history and COPD severity, mITT population

From: Benefits of budesonide/glycopyrronium/formoterol fumarate dihydrate on lung function and exacerbations of COPD: a post-hoc analysis of the KRONOS study by blood eosinophil level and exacerbation history

 

BGF

320/14.4/10 µg

GFF

14.4/10 µg

BFF

320/10 µg

EOS 100 to < 300 cells/mm3

   

Without exacerbation history in the preceding 12 months

N = 308

N = 307

N = 147

 Patients with exacerbations, n (%)

45 (14.6)

76 (24.8)

24 (16.3)

 Eventsa

50

99

25

 Total time at risk, years

131.31

126.63

61.30

 Adjusted COPD exacerbation rate (SE)b

0.35 (0.06)

0.79 (0.10)

0.38 (0.09)

With exacerbation history in the preceding 12 months

N = 102

N = 92

N = 45

 Patients with exacerbations, n (%)

22 (12.6)

32 (34.8)

16 (35.6)

 Eventsa

31

41

19

 Total time at risk, years

43.51

37.14

17.61

 Adjusted COPD exacerbation rate (SE)b

0.64 (0.14)

1.13 (0.23)

1.04 (0.31)

Moderate COPD

N = 201

N = 204

N = 90

 Patients with exacerbations, n (%)

25 (12.4)

44 (21.6)

17 (18.9)

 Eventsa

29

50

20

 Total time at risk, years

86.54

86.71

36.38

 Adjusted COPD exacerbation rate (SE)b

0.29 (0.06)

0.55 (0.09)

0.51 (0.13)

Severe COPD

N = 182

N = 163

N = 89

 Patients with exacerbations, n (%)

37 (20.3)

52 (31.9)

22 (24.7)

 Eventsa

47

66

23

 Total time at risk, years

77.54

65.04

37.12

 Adjusted COPD exacerbation rate (SE)b

0.55 (0.10)

1.10 (0.18)

0.62 (0.16)

Very severe COPD

N = 26

N = 32

N = 12

 Patients with exacerbations, n (%)

5 (19.2)

12 (37.5)

1 (8.3)

 Eventsa

5

24

1

 Total time at risk, years

10.27

12.01

4.94

 Adjusted COPD exacerbation rate (SE)b

0.43 (0.24)

1.47 (0.50)

0.15 (0.17)

EOS ≥ 100 cells/mm3

   

Without exacerbation history in the preceding 12 months

N = 363

N = 368

N = 179

 Patients with exacerbations, n (%)

51 (14.0)

90 (24.5)

27 (15.1)

 Eventsa

60

128

28

 Total time at risk, years

155.06

149.63

74.46

 Adjusted COPD exacerbation rate (SE)b

0.36 (0.057)

0.93 (0.117)

0.35 (0.081)

With exacerbation history in the preceding 12 months

N = 119

N = 116

N = 53

 Patients with exacerbations, n (%)

27 (22.7)

43 (37.1)

18 (34.0)

 Eventsa

37

64

22

 Total time at risk, years

50.55

46.12

21.25

 Adjusted COPD exacerbation rate (SE)b

0.69 (0.148)

1.53 (0.278)

1.07 (0.310)

Moderate COPD

N = 245

N = 250

N = 113

 Patients with exacerbations, n (%)

29 (11.8)

62 (24.8)

19 (16.8)

 Eventsa

34

90

23

 Total time at risk, years

105.78

103.10

46.29

 Adjusted COPD exacerbation rate (SE)b

0.28 (0.06)

0.92 (0.14)

0.45 (0.12)

Severe COPD

N = 205

N = 198

N = 104

 Patients with exacerbations, n (%)

43 (21.0)

59 (29.8)

24 (23.1)

 Eventsa

57

78

25

 Total time at risk, years

87.15

78.77

43.16

 Adjusted COPD exacerbation rate (SE)b

0.60 (0.10)

1.05 (0.16)

0.61 (0.15)

Very severe COPD

N = 30

N = 36

N = 14

 Patients with exacerbations, n (%)

6 (20.0)

12 (33.3)

2 (14.3)

 Eventsa

6

24

2

 Total time at risk, years

11.75

13.87

5.80

 Adjusted COPD exacerbation rate (SE)b

0.45 (0.25)

1.30 (0.46)

0.29 (0.24)

  1. aCOPD exacerbations were considered separate events provided that 7 or more days were between the recorded stop date of the earlier event and start date of the later
  2. bTreatments compared adjusting for baseline post-bronchodilator percent predicted FEV1 and log baseline EOS count as continuous covariates and baseline COPD exacerbation history (0, 1, ≥ 2) in the preceding 12 months, region, and ICS use at screening (yes/no) as categorical covariates using negative binomial regression; time at risk of experiencing an exacerbation was used as an offset variable in the model
  3. Abbreviations. BFF, budesonide/formoterol fumarate dihydrate; BGF, budesonide/glycopyrronium/formoterol fumarate dihydrate; COPD, chronic obstructive pulmonary disease; EOS, eosinophil; FEV1, forced expiratory volume in 1 s; GFF, glycopyrronium/formoterol fumarate dihydrate; ICS, inhaled corticosteroid; mITT, modified intention-to-treat; SE, standard error