Table 1 Summary of patient baseline characteristics by number of observed clinical benefits (responder analysis)
Baseline characteristics | Non-responders | Responders | ||||||
|---|---|---|---|---|---|---|---|---|
|  | 0 clinical benefits (N = 8) |  ≥ 1 clinical benefit (N = 137) |  ≥ 2 clinical benefits (N = 120) |  ≥ 3 clinical benefits (N = 92) |  ≥ 4 clinical benefits (N = 45) |  < 2 clinical benefits (N = 25) |  < 3 clinical benefits (N = 53) |  < 4 clinical benefits (N = 100) |
Age, years, mean (SD) | 49.5 (19.64) | 53.8 (13.48) | 54.2 (13.54) | 54.3 (13.97) | 53.9 (13.18) | 50.5 (15.05) | 52.3 (13.61) | 53.5 (14.17) |
Gender, female, % | 75 | 58 | 58 | 61 | 73 | 68 | 57 | 53 |
Race, n (%) | Â | Â | Â | Â | Â | Â | Â | Â |
 White | 6 (75) | 122 (89) | 107 (89) | 82 (89) | 39 (87) | 21 (84) | 46 (87) | 89 (89) |
 Asian | 0 | 5 (4) | 3 (3) | 2 (2) | 1 (2) | 2 (8) | 3 (6) | 4 (4) |
 Black or African American | 2 (25) | 9 (7) | 9 (8) | 7 (8) | 4 (9) | 2 (8) | 4 (8) | 7 (7) |
 Mixed | 0 | 1 (< 1) | 1 (< 1) | 1 (1) | 1 (2) | 0 | 0 | 0 |
BMI, kg/m2, mean (SD) | 29.8 (5.78) | 30.2 (6.31) | 30.0 (6.15) | 30.1 (6.18) | 30.0 (5.70) | 31.1 (6.89) | 30.4 (6.47) | 30.3 (6.53) |
Duration of asthma, years, mean (SD) | 30.9 (21.47) | 25.3 (16.54) | 25.0 (16.62) | 24.4 (15.63) | 26.2 (16.49) | 28.5 (17.71) | 27.7 (18.64) | 25.3 (17.02) |
Comorbidities at screening, n (%) | Â | Â | Â | Â | Â | Â | Â | Â |
 Allergic rhinitis | 1 (13) | 28 (20) | 23 (19) | 17 (18) | 11 (24) | 6 (24) | 12 (23) | 18 (18) |
 Nasal polyps | 0 | 20 (15) | 20 (17) | 15 (16) | 10 (22) | 0 | 5 (9) | 10 (10) |
Baseline maintenance OCS therapy, n (%) | 0 | 35 (26) | 31 (26) | 20 (22) | 8 (18) | 4 (16) | 15 (28) | 27 (27) |
Baseline maintenance OCS, mg/day, median (range) | 0 | 10.0 (4–40) | 10.0 (4–40) | 10.0 (4–40) | 5.0 (5–40) | 7.5 (5–20) | 10.0 (5–30) | 10.0 (4–40) |
Exacerbations in previous 12Â months, mean (SD) | 2.5 (1.07) | 3.3 (2.71) | 3.4 (2.79) | 3.5 (3.10) | 3.7 (3.52) | 2.7 (1.74) | 2.9 (1.55) | 3.1 (2.14) |
Pre-BD % predicted FEV1 at baseline, mean (SD) | 52.9 (23.91) | 59.9 (17.57) | 59.5 (17.71) | 59.4 (17.55) | 57.4 (16.79) | 59.5 (19.40) | 59.7 (18.76) | 60.5 (18.44) |
Pre-BD FEV1 at baseline, mL, mean (SD) | 1420 (550) | 1780 (690) | 1770 (700) | 1760 (670) | 1610 (570) | 1690 (580) | 1760 (700) | 1820 (720) |
Post-BD FEV1 at baseline, mL, mean (SD) | 1590 (650) | 2020 (800) | 2010 (810) | 2000 (770) | 1840 (660) | 1920 (730) | 1990 (850) | 2060 (850) |
Baseline ACQ-5 score, mean (SD) | 2.83 (0.705) | 3.21 (0.947) | 3.22 (0.942) | 3.25 (0.881) | 3.21 (0.832) | 3.06 (0.923) | 3.09 (1.030) | 3.18 (0.985) |
Baseline SGRQ total score, mean (SD) | 52.7 (15.32) | 56.8 (17.49) | 57.2 (18.00) | 56.1 (17.94) | 56.8 (17.36) | 53.5 (13.78) | 57.5 (16.43) | 56.5 (17.44) |
Baseline blood eosinophil count, geometric mean (SD logs) | 290 (0.884) | 290 (1.151) | 290 (1.206) | 320 (1.220) | 310 (1.403) | 290 (0.722) | 250 (0.959) | 290 (0.998) |
Prior omalizumab therapy | Â | Â | Â | Â | Â | Â | ||
Duration of prior omalizumab use, median months (range) | 41.3 (6–63) | 29.4 (4–161) | 29.7 (4–161) | 29.4 (5–161) | 28.7 (5–129) | 27.4 (6–81) | 30.1 (4–104) | 30.5 (4–161) |
 Frequency of prior omalizumab dosing, n (%) |  |  |  |  |  |  |  |  |
 2-weekly | 4 (50) | 71 (52) | 61 (51) | 50 (54) | 23 (51) | 14 (56) | 25 (48) | 52 (53) |
 4-weekly | 4 (50) | 65 (48) | 58 (49) | 42 (46) | 22 (49) | 11 (44) | 27 (52) | 47 (47) |
Prior omalizumab monthly dose, mg, median (range) | 300 (150–900) | 450 (100–1200) | 450 (100–1200) | 450 (100–1200) | 450 (100–1200) | 525 (150–1200) | 450 (100–1200) | 450.0 (100–1200) |