Table 1.
Demographic and Main Clinical Outcomes
| n | ACQ7 | ACT | AQLQ | AcEx | Taking mOCSs, n | IgE, IU | FeNO, ppb | Blood eos, x109/L | Sputum eos, % | |
|---|---|---|---|---|---|---|---|---|---|---|
| Early (16 wk) | ||||||||||
| Responders | 121 (63.3%) | |||||||||
| Baseline | 121 | 2.9 (2.0–3.6) | 12.0 (9.0–17.0) | 3.8 (2.9–5.0) | 4.0 (3.0–6.0) | 41/41 (33.1%) | 231.0 (114.0–377.0) | 33.5 (17.3–59.0) | 0.26 (0.11–0.48) | 6.0 (0.9 –23.0) |
| 16 wk | 121 | 1.6 (1.0–2.1) | 18.0 (14.0–21.0) | 5.5 (4.5–6.2) | NA | 41/41 (32.2%) | NA | 23.5 (12.8–39.0) | 0.18 (0.10–0.38) | 1.6 (0.5–8.1) |
| 52 wk | 113 | 1.6 (0.9–2.3) | 18.0 (15.0–22.0) | 5.7 (4.8–6.3) | 1.0 (0.0–2.0) | 31/39 (30.6%) | NA | 26.0 (16.0–48.5) | 0.20 (0.11–0.37) | 2.3 (1.0–12.0) |
| Nonresponders | 70 (36.7%) | |||||||||
| Baseline | 70 | 2.9 (2.4–3.7) | 10.0 (9.0–13.0) | 3.7 (2.9–4.7) | 4.0 (2.0–6.0) | 34/34 (48.6%) | 157.0 (87.0–302.0) | 34.3 (16.0–63.0) | 0.23 (0.11–0.41) | 2.3 (0.9–13.9) |
| 16 wk | 70 | 2.6 (2.0–3.3) | 13.0 (10.0–16.0) | 4.2 (3.4–5.2) | NA | 34/34 (47.1%) | NA | 29.8 (19.0–52.0) | 0.15 (0.08–0.30) | 2.3 (0.6–5.6) |
| 52 wk | 60 | 2.4 (1.1–3.0) | 14.5 (10.5–19.0) | 4.6 (3.7–5.8) | 1.0 (0.0–3.0) | 25/29 (40.0%) | NA | 23.0 (15.0–41.0) | 0.17 (0.07–0.38) | 2.5 (0.5–10.0) |
| AcEx (52 wk) | ||||||||||
| Responders | 120 (71.0%) | |||||||||
| Baseline | 120 | 2.7 (2.0–3.6) | 12.0 (9.0–16.0) | 3.8 (3.0–5.0) | 4.0 (3.0–6.0) | 38/38 (31.7%) | 209.8 (112.5–326.4) | 33.0 (16.0–56.0) | 0.25 (0.11– 0.44) | 3.0 (1.0–17.8) |
| 16 wk | 120 | 1.9 (1.1–2.6) | 17.5 (14.0–21.0) | 5.2 (4.1–6.1) | NA | 38/38 (30.0%) | NA | 24.0 (14.0–37.0) | 0.19 (0.10–0.35) | 1.8 (0.5–5.8) |
| 52 wk | 120 | 1.6 (0.9–2.4) | 18.5 (13.5–22.0) | 5.6 (4.6–6.3) | 1.0 (0.0–2.0) | 29/38 (30.0%) | NA | 22.5 (15.5–42.0) | 0.20 (0.10–0.39) | 2.3 (0.8–12.3) |
| Nonresponders | 49 (29.0%) | |||||||||
| Baseline | 49 | 3.0 (2.3–3.7) | 10.0 (8.0–13.0) | 3.8 (2.9–4.8) | 4.0 (2.0–5.0) | 26/26 (53.1%) | 191.7 (98.0–360.0) | 31.3 (18.0–53.0) | 0.22 (0.11–0.50) | 7.8 (1.3–30.5) |
| 16 wk | 49 | 2.4 (1.6–3.0) | 13.0 (11.0–18.0) | 4.8 (3.7–5.7) | NA | 26/26 (51.0%) | NA | 28.0 (17.5–51.0) | 0.12 (0.09–0.30) | 2.3 (0.8–8.5) |
| 52 wk | 49 | 2.4 (1.4–3.0) | 14.0 (12.0–18.0) | 4.6 (3.9–5.6) | 3.0 (2.0–4.0) | 24/26 (51.0%) | NA | 31.0 (16.5–56.5) | 0.18 (0.10–0.38) | 2.9 (1.0–6.1) |
| mOCS (52 wk) | ||||||||||
| Responders | 37 (56.9%) | |||||||||
| Baseline | 37 | 2.4 (2.0–3.6) | 13.0 (10.0–19.0) | 4.0 (3.2–5.5) | 3.0 (2.0–4.0) | 37/37 (100%) | 177.0 (87.0–492.0) | 36.0 (19.0–55.5) | 0.24 (0.09– 0.37) | 3.9 (1.5–12.5) |
| 16 wk | 37 | 2.0 (1.3–2.6) | 18.0 (13.0–21.0) | 5.1 (4.4–6.1) | NA | 37/37 (100%) | NA | 30.0 (17.5–44.0) | 0.16 (0.07–0.30) | 3.5 (0.5–13.5) |
| 52 wk | 37 | 2.0 (0.9–2.9) | 17.0 (13.0–19.0) | 5.2 (4.6–6.1) | 1.0 (0.0–2.0) | 23/37 (62.2%%) | NA | 31.0 (19.5–63.0) | 0.25 (0.16–0.42) | 7.5 (1.0–21.0) |
| Nonresponder | 28 (43.1%) | |||||||||
| Baseline | 28 | 3.0 (2.4–3.9) | 11.0 (9.0–17.0) | 4.0 (3.2–4.6) | 4.0 (2.0–6.0) | 28/28 (100%) | 152.0 (101.0–254.0) | 30.0 (15.8–72.0) | 0.13 (0.06– 0.26) | 11.0 (0.8–13.0) |
| 16 wk | 28 | 2.4 (1.1–3.5) | 15.5 (10.5–21.5) | 4.9 (3.5–6.0) | NA | 28/28 (100%) | NA | 27.5 (20.8–61.8) | 0.10 (0.04–0.26) | 2.6 (1.5–8.5) |
| 52 wk | 28 | 2.3 (1.4–3.9) | 16.0 (10.5–22.0) | 4.6 (3.5–6.1) | 2.0 (1.0–3.5) | 28/28 (100%) | NA | 27.0 (15.5–63.5) | 0.12 (0.06–0.32) | 4.9 (1.3–24.8) |
| P values* | ||||||||||
| 16 wk | <0.001 | <0.001 | <0.001 | NA | NA | NA | 0.014 | 0.180 | 0.227 | |
| 52-wk AcEx | 0.005 | 0.002 | 0.001 | NA | NA | NA | 0.077 | 0.099 | 0.344 | |
| 52-wk mOCS | 0.479 | 0.853 | 0.442 | NA | NA | NA | 0.504 | 0.166 | 0.251 |
Definition of abbreviations: AcEx = acute exacerbation; ACQ = asthma control questionnaire; ACT = asthma control test; AQLQ-S = asthma quality of life questionnaire; FeNO = fractional exhaled nitric oxide; eo = eosinophil; mOCS = maintenance oral corticosteroid.
Data in parenthetical ranges are IQRs. Model: comparison of changes in variable values from baseline to 16 or 52 weeks, with variable after 16 of the 52 weeks of treatment = intercept + response group + variable at baseline. The numbers of participants who enrolled and remained in the study at 16 and 52 weeks are shown in the second column. The mOCS use data are shown as the numbers of participants taking a mOCS at the time of assessment as a proportion of the total numbers of patients assessed (i.e., still in the study) at that time point.
P values determined by analysis of covariance/quantile regression depending on the distribution of the data.