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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