Table 2 Baseline and final characteristics (per-protocol analysis)
Characteristics | Whole sample | Responders | Non-responders | Withdrew | p | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean/n/% | SD | Median | IQR | Mean/n/% | SD | Median | IQR | Mean/n/% | SD | Median | IQR | Mean/n/% | SD | Median | IQR | ||
General | |||||||||||||||||
n (male/female) | 279 (118/161) | 161 (65/96) | 48 (24/24) | 70 (29/41) | 0.488 | ||||||||||||
Age (year) | 53.79 | 12.48 | 53.00 | 20.00 | 52.96 | 11.35 | 52.00 | 17.00 | 54.06 | 12.18 | 53.50 | 18.50 | 55.51 | 14.96 | 55.00 | 24.00 | 0.274 |
Weight (kg) | 78.42 | 17.40 | 78.00 | 25.00 | 78.24 | 17.36 | 75.00 | 25.00 | 81.52 | 18.19 | 80.00 | 21.00 | 76.69 | 16.91 | 78.50 | 25 | 0.452 |
Total IgE (IU/ml) | 355.47 | 325.88 | 244.00 | 366.00 | 349.52 | 311.55 | 225.00 | 386.00 | 399.44 | 317.69 | 319.50 | 352.00 | 339.00 | 363.78 | 207.50 | 361.00 | 0.186 |
Omalizumab dose (mg/month) | 472.04 | 250.36 | 450.00 | 300.00 | 469.10 | 246.94 | 300.00 | 300.00 | 509.38 | 299.58 | 450.00 | 375.00 | 453.21 | 220.59 | 300.00 | 300.00 | 0.772 |
Baseline | |||||||||||||||||
FeNO (ppb) | 51.38 | 46.31 | 38.00 | 52.00 | 51.01 | 48.52 | 38.00 | 51.00 | 46.80 | 33.53 | 38.00 | 50.00 | 55.81 | 48.76 | 44.00 | 56.00 | 0.877 |
ACT (points) | 12.34 | 4.10 | 12.00 | 6.00 | 12.55 | 3.86 | 12.00 | 6.00 | 10.64 | 4.04 | 10.00 | 5.00 | 13.03 | 4.42 | 12.00 | 7.00 | 0.005 |
FEV1 (%pred) | 64.45 | 18.17 | 66.00 | 24.00 | 63.58 | 18.20 | 65.00 | 24.00 | 65.81 | 16.80 | 66.50 | 22.50 | 65.51 | 19.11 | 67.50 | 19.00 | 0.660 |
Severe exacerbations (n/year) | 2.55 | 3.80 | 2.00 | 2.00 | 2.78 | 4.55 | 2.00 | 2.00 | 2.88 | 2.51 | 2.00 | 2.00 | 1.80 | 2.20 | 1.00 | 2.00 | 0.007 |
Systemic corticosteroids (n/%) | 201/72,0% | 119/73,9% | 40/83,3% | 42/60,0% | 0.015 | ||||||||||||
Prednisone (mg/day) | 13.84 | 14.19 | 10.00 | 15.00 | 13.76 | 16.03 | 8.00 | 15.00 | 15.38 | 14.17 | 10.00 | 15.00 | 12.62 | 6.99 | 10.00 | 11.00 | 0.387 |
Final | |||||||||||||||||
FeNO (ppb) | 40.82 | 46.97 | 26.00 | 29.00 | 35.19 | 36.62 | 24.00 | 27.00 | 43.61 | 40.70 | 34.00 | 31.00 | 52.72 | 67.56 | 32.00 | 38.00 | 0.158 |
ACT (points) | 17.45 | 5.14 | 18.00 | 8.00 | 18.36 | 4.74 | 19.00 | 7.00 | 13.45 | 5.22 | 12.50 | 9.00 | 18.03 | 4.78 | 18.00 | 8.00 | < 0.001 |
FEV1 (%pred) | 72.14 | 21.90 | 73.00 | 29.00 | 72.16 | 22.12 | 71.00 | 29.00 | 69.23 | 17.96 | 66.00 | 24.00 | 74.06 | 23.81 | 76.50 | 31.00 | 0.278 |
Severe exacerbations (n/year) | 1.03 | 2.64 | 0.00 | 1.00 | 0.94 | 2.59 | 0.00 | 1.00 | 1.81 | 3.88 | 1.00 | 2.00 | 0.70 | 1.37 | 0.00 | 1.00 | 0.022 |
Systemic corticosteroids (n/%) | 121/43,4% | 68/42,2% | 27/56,3% | 26/37,1% | 0.109 | ||||||||||||
Prednisone (mg/day) | 10.40 | 12.63 | 5.00 | 6.00 | 9.07 | 11.41 | 5.00 | 18.00 | 16.78 | 18.06 | 10.00 | 15.00 | 7.23 | 4.19 | 8.50 | 5.00 | 0.008 |