Table 2.
Analysis for the co-primary PK endpoints (PK population).
| Comparison | Parameter (unit) |
Treatment | na | Geometric LS Meanb | % Ratiob (T/R) |
90% CIb |
|---|---|---|---|---|---|---|
| CT-P10 (T) vs. US-RTX (R) |
AUC0–last (h*µg/mL) |
Test Reference |
62 60 |
162414.81 167309.07 |
97.07 | (88.08, 106.99) |
| AUC0–∞ (h*µg/mL) |
Test Reference |
59 60 |
162377.28 169480.80 |
95.81 | (87.39, 105.04) | |
| Cmax (µg/mL) |
Test Reference |
62 59 |
367.03 386.65 |
94.92 | (89.61, 100.55) | |
| CT-P10 (T) vs. EU-RTX (R) |
AUC0–last (h*µg/mL) |
Test Reference |
62 59 |
162414.81 172450.97 |
94.18 | (85.40, 103.86) |
| AUC0–∞ (h*µg/mL) |
Test Reference |
59 56 |
162377.28 180637.81 |
89.89 | (81.85, 98.72) | |
| Cmax (µg/mL) |
Test Reference |
62 59 |
367.03 412.40 |
89.00 | (84.01, 94.28) | |
| EU-RTX (T) vs. US-RTX (R) |
AUC0–last (h*µg/mL) |
Test Reference |
59 60 |
172450.97 167309.07 |
103.07 | (93.32, 113.85) |
| AUC0–∞ (h*µg/mL) |
Test Reference |
56 60 |
180637.81 169480.80 |
106.58 | (97.03, 117.08) | |
| Cmax (µg/mL) |
Test Reference |
59 59 |
412.40 386.65 |
106.66 | (100.56, 113.13) |
AUC0–last = area under the serum concentration–time curve from time 0 to the last measurable concentration. AUC0–∞ = AUC from time 0 extrapolated to infinity. CI = confidence interval. Cmax = maximum serum concentration after the second infusion. EU = European Union. LS = least squares. PK = pharmacokinetics. R = reference. RTX = rituximab. T = test. US = United States.
aOutliers were excluded from the statistical analysis (n = 3 in US-RTX for AUC0–last and Cmax and n = 2 in US-RTX for AUC0–∞). In addition, some patients were excluded from the statistical analysis for AUC0–∞ since R-square was lower than 0.8 in the terminal phase and the terminal slope could not be calculated (n = 3 in CT-P10; n = 1 in US-RTX; n = 3 in EU-RTX).
bPoint estimates and 90% CIs for differences on the log scale were exponentiated to obtain estimates for ratios of geometric LS means on the original scale.