Table 4.
Omalizumab | Mepolizumab | Benralizumab | Dupilumab | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
T0 | T1 | T2 | T3 | T4 | T0 | T1 | T2 | T3 | T4 | T0 | T1 | T2 | T0 | T1 | |
BDP HFA dose, mcg | 673.17 ± 244.97 | 662.50 ± 258.88 | 590.91 ± 271.99 | 558.06 ± 293.00 | 500.00 ± 258.20 * | 650.00 ± 174.93 | 580.00 ± 261.41 | 600.00 ± 215.21 | 600.00 ± 181.50 | 688.89 ± 247.21 | 783.33 ± 154.35 | 766.67 ± 123.67 | 650.00 ± 232.99 | 757.89 ± 216.84 | 800.00 ± 240.37 |
ACT score | 19.37 ± 2.97 | 20.70 ± 2.56 * | 21.03 ± 3.48 * | 20.83 ± 3.44 | 21.57 ± 2.92 * | 16.69 ± 4.84 | 20.67 ± 3.41 °° | 20.40 ± 4.67 ° | 21.83 ± 3.00 °°°° | 22.22 ± 3.42 °° | 17.61 ± 4.98 | 21.94 ± 4.28 # | 21.00 ± 3.96 | 15.42 ± 4.55 | 20.00 ± 3.86 §§ |
Activity limitation | 3.19 ± 1.08 | 4.05 ± 0.90 * | 4.35 ± 1.00 ** | 4.17 ± 1.20 * | 4.50 ± 1.16 * | 3.12 ± 1.24 | 3.92 ± 0.97 ° | 3.95 ± 1.19 ° | 4.39 ± 0.78 °°° | 4.56 ± 0.73 °° | 3.44 ± 1.46 | 4.17 ± 1.25 | 4.38 ± 0.74 # | 2.84 ± 1.21 | 3.95 ± 1.13 § |
Nocturnal symptoms | 4.52 ± 0.87 | 4.82 ± 0.50 | 4.76 ± 0.97 | 4.83 ± 0.38 | 4.93 ± 0.27 | 3.85 ± 1.46 | 4.83 ± 0.64 ° | 4.30 ± 1.38 | 4.67 ± 0.77 ° | 4.67 ± 1.00 | 3.82 ± 1.59 | 4.61 ± 1.04 | 4.88 ± 0.35 # | 3.95 ± 1.58 | 4.26 ± 1.15 |
Exacerbations/year | 3.15 ± 3.07 | 1.00 ± 1.47 *** | 1.22 ± 1.70 ** | 1.68 ± 1.72 * | 1.13 ± 1.58 ** | 4.27 ± 2.91 | 1.08 ± 1.35 °°°° | 0.75 ± 0.91 °°°° | 0.61 ± 0.70 °°°° | 0.44 ± 0.73 °°°° | 4.00 ± 2.83 | 0.89 ± 0.90 ## | 1.12 ± 1.25 ## | 2.58 ± 1.95 | 0.42 ± 0.96 §§§ |
FVC abs. (L) | 2.76 ± 1.04 | 3.04 ± 1.12 | 2.94 ± 1.07 | 2.94 ± 1.07 | 2.78 ± 1.03 | 2.79 ± 1.05 | 3.02 ± 1.19 | 2.88 ± 0.86 | 3.39 ± 1.34 | 2.81 ± 0.72 | 2.95 ± 0.99 | 3.11 ± 1.11 | 3.44 ± 1.22 | 2.37 ± 0.60 | 2.54 ± 0.69 |
FVC % pred. | 89.02 ± 18.91 | 97.72 ± 16.27 * | 95.55 ± 16.57 | 97.63 ± 17.47 * | 99.08 ± 18.92 * | 83.50 ± 16.67 | 91.61 ± 25.16 | 99.12 ± 27.29 ° | 108.40 ± 16.15 °°°° | 98.71 ± 18.51 | 93.56 ± 22.56 | 96.61 ± 23.09 | 105.00 ± 23.00 | 83.05 ± 19.70 | 85.71 ± 21.93 |
FEV1 abs. (L) | 1.67 ± 0.63 | 1.87 ± 0.72 | 1.87 ± 0.63 | 1.90 ± 0.71 | 1.81 ± 0.73 | 1.72 ± 0.86 | 2.01 ± 1.04 | 1.82 ± 0.73 | 2.33 ± 1.15 | 1.89 ± 0.57 | 1.87 ± 0.75 | 2.11 ± 1.00 | 2.72 ± 0.95 # | 1.32 ± 0.51 | 1.58 ± 0.65 |
FEV1 % pred. | 65.08 ± 15.71 | 72.97 ± 17.64 * | 75.30 ± 16.93 * | 77.26 ± 19.49 * | 76.70 ± 21.90 * | 62.88 ± 19.41 | 73.62 ± 28.37 | 76.06 ± 28.78 | 86.73 ± 20.79 °° | 81.43 ± 18.61 ° | 72.67 ± 21.08 | 79.06 ± 28.85 | 98.12 ± 20.57 # | 57.21 ± 18.89 | 64.47 ± 19.23 |
IT abs. | 59.19 ± 13.47 | 61.69 ± 9.19 | 63.43 ± 9.53 | 63.97 ± 11.01 | 61.21 ± 11.53 | 58.59 ± 11.70 | 61.18 ± 12.54 | 60.10 ± 12.97 | 64.33 ± 13.04 | 65.99 ± 8.27 | 60.24 ± 14.47 | 62.21 ± 14.24 | 72.00 ± 5.63 # | 53.58 ± 13.11 | 59.56 ± 13.12 |
IT % pred. | 69.50 ± 13.71 | 77.82 ± 11.10 * | 78.85 ± 12.5 * | 79.41 ± 14.3 * | 75.96 ± 13.12 | 74.46 ± 15.65 | 76.77 ± 15.77 | 73.88 ± 16.09 | 80.67 ± 17.22 | 79.43 ± 8.89 | 75.29 ± 18.95 | 79.94 ± 19.59 | 94.14 ± 8.13 ## | 67.78 ± 15.90 | 73.33 ± 15.43 |
RV abs. (L) | 3.08 ± 1.04 | 2.63 ± 0.78 | 2.57 ± 1.06 | 2.79 ± 0.82 | 2.18 ± 0.85 * | 3.18 ± 1.03 | 2.85 ± 0.97 | 3.08 ± 0.83 | 2.55 ± 0.56 | 2.44 ± 0.73 | 3.22 ± 1.4 | 2.78 ± 1.17 | 3.25 ± 2.08 | 3.13 ± 1.14 | 2.47 ± 0.07 § |
RV % pred. | 159.11 ± 46.37 | 127.15 ± 38.82 * | 132.64 ± 44.90 | 139.33 ± 42.27 | 113.00 ± 28.21 ** | 148.73 ± 45.27 | 143.13 ± 51.42 | 154.36 ± 36.97 | 127.58 ± 31.77 | 121.20 ± 41.03 | 139.72 ± 49.73 | 142.71 ± 50.81 | 105.43 ± 46.24 | 150.94 ± 44.80 | 125.33 ± 41.85 |
FVC post BD abs.(L) | 3.03 ± 1.21 | 3.48 ± 1.26 | 3.03 ± 0.63 | 2.99 ± 0.78 | 2.82 ± 1.23 | 2.95 ± 1.24 | 3.13 ± 1.08 | 3.02 ± 0.96 | 3.62 ± 1.29 | 3.21 ± 0.46 | 3.22 ± 1.11 | 3.30 ± 1.08 | 3.35 ± 1.52 | 2.57 ± 0.66 | 2.69 ± 0.73 |
FVC Delta abs. post BD (L) | 0.33 ± 0.28 | 0.15 ± 0.21 * | 0.22 ± 0.29 | 0.18 ± 0.17 | 0.16 ± 0.21 | 0.27 ± 0.21 | 0.15 ± 0.12 | 0.20 ± 0.22 | 0.17 ± 0.19 | 0.08 ± 0.03 ° | 0.25 ± 0.22 | 0.24 ± 0.33 | 0.16 ± 0.14 | 0.23 ± 0.17 | 0.19 ± 0.16 |
FVC Delta % post BD | 11.92 ± 9.24 | 6.48 ± 9.08 | 8.95 ± 13.60 | 6.39 ± 7.20 | 4.00 ± 6.22 * | 9.12 ± 7.18 | 4.93 ± 4.25 | 6.62 ± 5.84 | 5.75 ± 6.95 | 2.42 ± 1.25 °° | 7.36 ± 7.23 | 5.87 ± 6.96 | 5.62 ± 3.74 | 8.05 ± 9.17 | 9.91 ± 8.58 |
FEV1 post abs. (L) | 1.95 ± 0.76 | 2.06 ± 0.84 | 1.84 ± 0.49 | 1.99 ± 0.59 | 2.01 ± 0.79 | 1.82 ± 1.10 | 2.26 ± 0.95 | 2.01 ± 0.88 | 2.58 ± 1.10 | 2.38 ± 0.21 | 2.05 ± 0.85 | 2.20 ± 0.82 | 2.56 ± 1.24 | 1.53 ± 0.63 | 1.60 ± 0.62 |
FEV1 Delta Post BD abs. (L) | 0.24 ± 0.17 | 0.17 ± 0.12 | 0.15 ± 0.15 | 0.16 ± 0.14 | 0.21 ± 0.17 | 0.23 ± 0.19 | 0.16 ± 0.10 | 0.10 ± 0.46 | 0.17 ± 0.16 | 0.13 ± 0.14 | 0.18 ± 0.22 | 0.17 ± 0.20 | 0.13 ± 0.15 | 0.21 ± 0.18 | 0.17 ± 0.06 |
FEV1 Delta % post BD | 15.58 ± 8.35 | 10.60 ± 8.24 | 8.38 ± 7.67 * | 9.39 ± 9.98 | 11.55 ± 6.71 | 15.66 ± 9.72 | 7.52 ± 2.91 °° | 1.72 ± 33.20 | 8.37 ± 10.17 | 6.55 ± 7.31 | 10.49 ± 12.76 | 10.49 ± 9.79 | 6.13 ± 5.31 | 16.16 ± 9.36 | 13.75 ± 9.05 |
DLCO % | 87.71 ± 9.94 | 98.75 ± 21.87 | 105.50 ± 17.68 | 92.60 ± 14.98 | 97.00 ± 22.00 | 78.42 ± 23.13 | 64.00 ± 46.67 | 88.20 ± 15.06 | 85.38 ± 26.87 | 92.67 ± 24.01 | 94.50 ± 17.68 | 76.60 ± 13.94 | 89.00 ± 19.37 | ||
FENO (ppb) | 35.47 ± 27.81 | 31.54 ± 21.89 | 42.64 ± 34.23 | 35.85 ± 17.31 | 48.11 ± 51.61 | 52.73 ± 33.00 | 56.87 ± 50.08 | 41.99 ± 30.12 | 59.75 ± 50.89 | 39.96 ± 24.39 | 50.84 ± 60.13 | 53.60 ± 40.48 | 31.13 ± 22.94 | 29.48 ± 17.17 | |
Total IgE (UI/mL) | 323.45 ± 261.19 | 792.33 ± 649.35 * | 606.55 ± 419.06 * | 557.97 ± 409.13 * | 576.06 ± 519.86 | 307.65 ± 421.13 | 236.91 ± 152.03 | 197.13 ± 213.36 | 149.00 ± 49.50 | 641.95 ± 833.04 | 466.07 ± 461.11 | 613.67 ± 793.41 | 327.75 ± 649.39 | 221.05 ± 280.84 | |
Leukocytes absolute count (cells/mcl) | 8190.00 ± 1951.47 | 7357.42 ± 1952.10 | 7977.14 ± 3673.14 | 7351.15 ± 1679.39 | 7321.50 ± 2063.33 | 7771.65 ± 1822.44 | 7977.39 ± 1870.07 | 7325.56 ± 2491.86 | 7248.82 ± 2038.64 | 7220.00 ± 1464.66 | 8248.75 ± 1923.05 | 7551.76 ± 2973.69 | 6182.86 ± 1190.44 ## | 9152.63 ± 2546.82 | 8011.25 ± 1772.18 |
Neutrophils % | 55.12 ± 9.19 | 59.48 ± 11.54 | 58.88 ± 8.09 | 54.04 ± 7.84 | 56.07 ± 7.01 | 52.95 ± 10.77 | 57.99 ± 8.98 | 55.28 ± 10.03 | 60.73 ± 11.93 | 56.89 ± 7.43 | 54.54 ± 8.11 | 58.46 ± 10.16 | 49.07 ± 9.79 | 58.55 ± 11.33 | 53.83 ± 5.49 |
Neutrophils absolute count (cells/mcl) | 4588.46 ± 1583.27 | 4246.47 ± 1556.59 | 5072.31 ± 2982.80 | 4062.31 ± 1195.96 | 4072.22 ± 1414.37 | 4058.47 ± 1566.19 | 4574.55 ± 1522.37 | 4115.00 ± 1994.25 | 4817.65 ± 2309.18 | 4085.71 ± 821.52 | 4570.62 ± 1274.58 | 4490.00 ± 2040.00 | 3115.00 ± 299.25 ## | 5266.84 ± 1930.38 | 4304.50 ± 1610.92 |
Eosinophils % | 5.44 ± 4.06 | 4.59 ± 3.71 | 5.17 ± 4.76 | 5.35 ± 3.44 | 5.03 ± 2.97 | 7.02 ± 4.13 | 1.43 ± 1.16 °°°° | 1.50 ± 1.25 °°°° | 1.29 ± 1.37 °°°° | 1.04 ± 0.59 °°°° | 7.00 ± 5.57 | 0.53 ± 2.00 ### | 0.00 ± 0.00 #### | 3.59 ± 2.59 | 5.94 ± 6.57 |
Eosinophils absolute count (cells/mcl) | 426.79 ± 310.28 | 341.68 ± 271.28 | 363.29 ± 271.66 | 396.40 ± 231.73 | 403.12 ± 218.90 | 560.38 ± 312.03 | 108.26 ± 79.98 °°°° | 105.00 ± 81.47 °°°° | 85.88 ± 81.17 °°°° | 74.29 ± 38.23 °°°° | 563.89 ± 468.83 | 47.06 ± 188.94 ### | 0.00 ± 0.00 #### | 296.84 ± 193.16 | 527.06 ± 613.29 |
Fibrinogen (mg/dl) | 356.62 ± 95.72 | 344.33 ± 100.47 | 330.67 ± 73.95 | 429.40 ± 88.71 | 363.40 ± 112.49 | 369.25 ± 95.12 | 404.22 ± 101.63 | 419.75 ± 129.64 | 327.29 ± 86.61 | 327.67 ± 92.39 | 294.00 ± 75.36 | 366.86 ± 79.42 | 382.50 ± 98.99 |
BDP HFA dose: beclomethasone mcg equivalent dose hydrofluoroalkane, FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity, Abs: absolute, Post BD: post bronchodilators, pred.: predicted, IT: Tiffenau index, RV: residual volume, DLCO: diffusion capacity for carbon monoxide, and FeNO: exhaled nitric oxide. Results are expressed as mean ±standard deviation significance vs. T0 in omalizumab: * < 0.05, ** < 0.001,*** < 0.0001, significance vs. T0 in mepolizumab: ° < 0.05, °° < 0.001, °°° < 0.0001, °°°° < 0.00001, significance vs. T0 in benralizumab: # < 0.05, ## < 0.001, ### < 0.0001, #### < 0.00001, and significance vs. T0 in dupilumab: § < 0.05, §§ < 0.001, §§§ < 0.0001,. Empty cells: not enough values for calculation.