Table 2.
Ratio of adjusted least squares geometrical means of ABP 501, adalimumab (USA) and adalimumab (EU) (PK parameter population)
| Treatment comparison | Cmax, µg/mL (90% CI) | AUCinf, µg·h/mL (90% CI) | AUClast, µg·h/mL (90% CI) |
|---|---|---|---|
| ABP 501 vs adalimumab (USA) | 1.04 (0.96 to 1.12) | 1.11 (1.00 to 1.24) | 1.07 (0.96 to 1.18) |
| ABP 501 vs adalimumab (EU) | 0.96 (0.89 to 1.03) | 1.04 (0.94 to 1.17) | 0.99 (0.89 to 1.10) |
| Adalimumab (USA) vs adalimumab (EU) | 0.92 (0.86 to 0.994) | 0.94 (0.84 to 1.04) | 0.93 (0.84 to 1.03) |
AUCinf, area under the serum concentration-time curve from time 0 extrapolated to infinity; AUClast, area under the serum concentration-time curve from time 0 to the last quantifiable concentration; Cmax, maximum observed concentration; PK, pharmacokinetic.