Skip to main content

Table 2 Comparison among groups. Real-life population and regulatory studies. The significant difference for the available parameters are indicated in boldface

From: The North-Western Italian experience with anti IL-5 therapy amd comparison with regulatory trials

  

CURRENT POPULATION

SIRIUS (11)

MENSA(10)

DREAM (8)

MUSCA (9)

Age

Mean ± SD (range)

56 ± 11.5 (19–84)

50 (n.p.) (16–74)

50 (n.p.) (12–82)

46 ± 11.2 (n.p.)

51 ± 13.4 (n.p.)

P-value

<  0.0001

<  0.0001

<  0.0001

< 0.0001

Female %

N (%)

29 (45)

27 (55)

329 (57)

392 (63)

325 (58)

P-value

n.s

n.s

0.003

0.039

Duration of asthma (years)

Mean ± SD

18.2 ± 14.4

18.27 ± 13.1

19.9 ± 13.8

19.1 ± 45.8

19.5 ± 14.8

P-value

n.s.

n.s

n.s

n.s

Smoker

N (%)

17 (26)

53 (39)

159 (28)

133 (22)

147 (26)

P-value

0.04

n.s.

n.s

n.s

FEV1%

Mean ± SD

73 ± 18.1

58.7 ± 17.7

61 ± 17.9

60 ± 16

55 ± 14.5

P-value

<  0.0001

<  0.0001

<  0.0001

<  0.0001

Eosinophils baseline (cells/μl)a

Mean ± SD

N (%)

653 ± 381

≥150 = 64 (98)

≥300 = 9 (91)

240 ± 1126

(n.p.)

(n.p.)

296 ± 992

(n.p.)

(n.p.)

253 ± 1022

(n.p.)

n.p.)

325 (n.p.)

≥150 = 474 (86)b

≥300 = 351 (64)b

P-value

<  0.0001

<  0.0001

<  0.0001

0.0043 b

< 0.0001 b

Exacerbations/ 12 months

Mean ± SD

3 (1.8)

3.1 (3.1)

3.6 (2.6)

3.58 (3.03)

2.8 (1.7)

P-value

n.s.

0.0047

0.0087

n.s.

ER access/ 12 months

N (%)

20 (31)

23 (17)

109 (19)

150 (24)

179 (32)

P-value

0.005

n.s

n.s

n.s

OCS dose at baseline

Median (range)

Mean (SD)

9 (0–50)

9.2 ± 9.2

13.7 (5–35)

(n.p.)

13.2 (1–80)

(n.p.)

10.8 (8–20)

(n.p.)

(n.p.)

13 (±10.9)

P-value

0.0002

0.0007

n.s.

0.0014

Nasal polyposis

N (%)

47 (72)

33 (24)

281 (49)

62 (10)

105 (19)

P-value

< 0.0001

< 0.0001

< 0.0001

< 0.0001

  1. aGeometric mean, n.p not provided, bcomparison in % of patients, n.s not significant