TABLE 2.
Entire cohort | Received biologic | p-value | ||
No | Yes | |||
Patients | 1140 | 213 | 927 | |
Follow-up time (days) | 406 (363–497) | 413 (357–511) | 405 (363–494) | 0.586 |
BMI (kg·m−2) | 31.1±7.2 | 31.4±8.3 | 31.0±6.9 | 0.465 |
Exacerbations (prior year) (n) | 1 (0–3) | 2 (0–4) | 1 (0–3) | 0.129 |
0 | 371 (33.7) | 63 (31.2) | 308 (34.3) | |
1 | 205 (18.6) | 35 (17.3) | 170 (18.9) | |
2 | 152 (13.8) | 21 (10.4) | 131 (14.6) | |
3 | 109 (9.9) | 30 (14.9) | 79 (8.8) | |
4+ | 264 (24.0) | 53 (26.2) | 211 (23.5) | |
Any ED attendance (prior year) | 170 (15.6) | 43 (21.4) | 127 (14.3) | 0.012 |
Any hospital admission (prior year) | 187 (17.2) | 44 (21.8) | 143 (16.1) | 0.053 |
Blood eosinophil count (×109 L−1) | 0.10 (0.01–0.23) | 0.30 (0.15–0.50) | 0.08 (0.00–0.19) | <0.001 |
FENO (ppb) | 36 (20–67) | 33 (21–55) | 36 (20–70) | 0.362 |
FEV1 (L) | 2.10±0.79 | 2.06±0.75 | 2.11±0.80 | 0.458 |
FEV1 (% pred) | 70.3±20.9 | 70.6±19.5 | 70.3±21.2 | 0.871 |
FVC (L) | 3.17±1.03 | 3.06±1.03 | 3.19±1.03 | 0.150 |
FVC (% pred) | 84.9±19.3 | 84.0±18.8 | 85.2±19.4 | 0.497 |
FEV1/FVC | 66.4±13.3 | 67.9±12.1 | 66.1±13.6 | 0.115 |
ACQ-6 score | 2.0 (0.8–3.3) | 2.8 (1.5–3.8) | 1.8 (0.8–3.2) | <0.001 |
Uncontrolled asthma (ACQ-6 >1.5) | 556 (59.8) | 112 (74.7) | 444 (57.0) | <0.001 |
EuroQoL utility | 0.76 (0.49–0.92) | 0.73 (0.43–0.88) | 0.78 (0.50–0.94) | 0.175 |
mOCS | 587 (51.6) | 84 (39.6) | 503 (54.3) | <0.001 |
mOCS dose (prednisolone-equivalent mg) | 8 (5–13) | 10 (5–10) | 8 (5–13) | 0.270 |
Difference from baseline | ||||
ACQ-6 score improvement | 0.7 (0.0–1.5) | 0.3 (−0.7–0.8) | 0.8 (0.0–1.7) | <0.001 |
EuroQoL utility | 0.02 (−0.07–0.15) | 0.01 (−0.09–0.12) | 0.02 (−0.06–0.16) | 0.306 |
Exacerbations (prior year) (%) | −75.0 (−100.0– −33.3) | −54.2 (−100.0–0.0) | −75.0 (−100.0– −40.0) | <0.001 |
ED/hospitalisation (prior year) (%) | −100.0 (−100.0– −66.7) | −100.0 (−100.0– −25.0) | −100.0 (−100.0– −66.7) | 0.030 |
Blood eosinophil count (×109 L−1) | −73.3 (−95.1–0.0) | 0.0 (−50.0–67.9) | −80.0 (−97.7– −27.9) | <0.001 |
FENO (ppb) | −8.0 (−41.4–43.5) | −5.7 (−34.4–30.8) | −8.6 (−42.2–49.4) | 0.671 |
FEV1 (mL) | 20.0 (−200.0–340.0) | 0.0 (−200.0–285.0) | 30.0 (−200.0–350.0) | 0.279 |
mOCS change | 0.003 | |||
Discontinue | 129 (20.2) | 13 (16.0) | 116 (20.8) | |
Decrease dose | 301 (47.2) | 27 (33.3) | 274 (49.2) | |
Maintain dose | 148 (23.2) | 29 (35.8) | 119 (21.4) | |
Increase dose | 60 (9.4) | 12 (14.8) | 48 (8.6) | |
Clinically important differences | ||||
ACQ-6 improvement | 523 (62.5) | 59 (41.8) | 464 (66.7) | <0.001 |
Exacerbation reduction | 746 (69.0) | 117 (60.0) | 629 (71.0) | 0.003 |
Unscheduled care reduction | 915 (85.5) | 151 (77.0) | 764 (87.4) | <0.001 |
FEV1 | 402 (42.5) | 63 (37.5) | 339 (43.6) | 0.149 |
OCS | 738 (64.9) | 143 (67.1) | 595 (64.4) | 0.450 |
Positive outcomes (n) | 3 (2–4) | 3 (2–4) | 3 (2–4) | <0.001 |
0 | 18 (2.7) | 1 (0.9) | 17 (3.0) | |
1 | 57 (8.4) | 14 (12.6) | 43 (7.6) | |
2 | 125 (18.4) | 32 (28.8) | 93 (16.4) | |
3 | 172 (25.4) | 31 (27.9) | 141 (24.9) | |
4 | 201 (29.6) | 26 (23.4) | 175 (30.9) | |
5 | 105 (15.5) | 7 (6.3) | 98 (17.3) |
Data are presented as n, median (interquartile range), mean±sd or n (%), unless otherwise stated. BMI: body mass index; ED: emergency department; FENO: exhaled nitric oxide fraction; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; ACQ-6: Asthma Control Questionnaire-6; mOCS: maintenance oral corticosteroids. Definitions of clinically important differences: ACQ-6 improvement ≥0.5 or well controlled (ACQ-6 ≤0.75), exacerbation reduction ≥50% or no exacerbations, unscheduled care reduction ≥50% or no unscheduled care, FEV1 increase ≥100 mL and OCS dose decrease ≥50% or not receiving mOCS at follow-up.