Table 4.
Pharmacokinetic endpoints during the second course of treatment (pharmacokinetic populationa)
| Endpoint | CT-P10 (n = 57) | RTX (n = 21) |
|---|---|---|
| C min (µg/ml) | ||
| Mean (SD) | 0.08 ± 0.14 | 0.03 ± 0.03 |
| Median (range) | 0.02 (0.02–0.70) | 0.02 (0.02–0.12) |
| C max,1 (µg/ml) | ||
| Mean (SD) | 328.35 ± 123.02 | 353.79 ± 109.35 |
| Median (range) | 352.00 (25.2–545.0) | 387.00 (85.6–537.0) |
| C trough (µg/ml) | ||
| Mean (SD) | 75.95 ± 25.93 | 80.41 ± 18.64b |
| Median (range) | 81.30 (25.2–132.0) | 81.25 (46.0–131.0)b |
| C max,2 (µg/ml) | ||
| Mean (SD) | 434.28 ± 92.28 | 440.05 ± 85.62 |
| Median (range) | 435.00 (228.0–613.0) | 462.00 (261.0–575.0) |
C max,1 maximum serum concentration after the first infusion of the second course, C max,2 maximum serum concentration after the second infusion of the second course, C min serum concentration immediately before the start of the first infusion of the second treatment course, C trough trough serum concentration before the second infusion of the second course, RTX innovator rituximab, SD standard deviation
aAll patients who received a second course of CT-P10 or RTX and provided sufficient blood concentration data
b n = 20