Table 4. Summary of derived blood and sputum eosinophil parameters by treatment group.
| Parameter (unit) | Summary statistics | Mepolizumab dose | |||
|---|---|---|---|---|---|
| SC 12.5 mg n = 21 | SC 125 mg n = 15 | SC 250 mg n = 23 | IV 75 mg n = 11 | ||
| Blood eosinophils | |||||
| AUECeos(0–day 84) (GI.d/L) | n | 20 | 14 | 21 | 11 |
| Geo mean | 21.551 | 7.198 | 6.381 | 7.556 | |
| 95% CI | 15.486 – 29.991 | 5.290 – 9.796 | 4.915 – 8.284 | 5.459 – 10.459 | |
| Proportional inhibition AUECeos(0–day 84) | n | 20 | 14 | 21 | 11 |
| Geo mean | 0.396 | 0.743 | 0.818 | 0.687 | |
| 95% CI | 0.263 – 0.596 | 0.679 – 0.813 | 0.780 – 0.857 | 0.602 – 0.784 | |
| wmeaneos(0–day 84) (GI/L) | n | 21 | 15 | 23 | 11 |
| Geo mean | 0.251 | 0.090 | 0.083 | 0.090 | |
| 95% CI | 0.183 – 0.345 | 0.066 – 0.121 | 0.063 – 0.109 | 0.065 – 0.125 | |
| Maxeos (GI/L) | n | 21 | 15 | 23 | 11 |
| Geo mean | 0.203 | 0.113 | 0.082 | 0.141 | |
| 95% CI | 0.124 – 0.331 | 0.079 – 0.162 | 0.057 – 0.119 | 0.085 – 0.233 | |
| tmaxeos (Days) | n | 21 | 15 | 23 | 11 |
| Arithmetic mean | 50.0 | 49.4 | 47.0 | 58.8 | |
| 95% CI | 34.6 – 65.5 | 34.0 – 64.8 | 32.0 – 62.0 | 42.0 – 75.6 | |
| Subjects achieving ≥ 50% repletion | n (%) | 8 (38) | 1 (7) | 2 (9) | 1 (9) |
| Sputum eosinophils | |||||
| Proportional Inhibition AUECspeos(0–day 84) | n | 10 | 5 | 13 | 7 |
| Geo mean | 0.315 | 0.627 | 0.693 | 0.690 | |
| 95% CI | 0.125 – 0.793 | 0.377 – 1.045 | 0.562 – 0.856 | 0.579 – 0.821 | |
| wmeanspeos(0–day 84) (%) | n | 16 | 8 | 13 | 7 |
| Geo mean | 7.734 | 1.368 | 2.551 | 1.938 | |
| 95% CI | 3.914 – 15.283 | 0.772 – 2.424 | 1.075 – 6.054 | 0.580 – 6.473 | |
| Maxspeos (%) | n | 15 | 6 | 13 | 7 |
| Geo mean | 0.228 | 0.025 | 0.042 | 0.122 | |
| 95% CI | 0.112 – 0.465 | 0.006 – 0.101 | 0.016 – 0.110 | 0.032 – 0.466 | |
| tmaxspeos (Days) | n | 15 | 6 | 13 | 7 |
| Arithmetic mean | 33.6 | 43.2 | 50.6 | 27.0 | |
| 95% CI | 20.7 – 46.5 | 14.4 – 72.0 | 33.2 – 68.0 | 6.7 – 47.3 | |
AUECeos(0–day 84) = area under the absolute blood eosinophil-time curve to day 84 determined using the linear trapezoidal rule, for subset of subjects with blood eosinophil data to day 84; proportional inhibition AUECeos(0–day 84) = area above the absolute blood eosinophil-time curve to day 84 as a proportion of the total area under the baseline blood eosinophil level to day 84, for subset of subjects with blood eosinophil data to day 84; wmeaneos(0–day 84) = weighted mean absolute blood eosinophil levels (day 0 – 84 or last day with available eosinophil data prior to day 84; Maxeos = maximum reduction from baseline in blood eosinophils (between day 0 and last quantifiable measurement); tmaxeos = time to first occurrence of maximum reduction from baseline in blood eosinophil levels (between day 0 and last quantifiable measurement); proportional inhibition AUECspeos(0–day 84) = area above the percent sputum eosinophil-time curve to day 84 as a proportion of the total area under the baseline percent sputum eosinophil level to day 84; wmeanspeos(0–day 84) = weighted mean percent sputum eosinophil levels (day 0 – 84 or last day with available eosinophil data prior to day 84; Maxspeos = maximum reduction from baseline in percent sputum eosinophils; tmaxspeos = time to maximum reduction in percent sputum eosinophil levels; Geo = geometric; CI = confidence interval.