Summary of ABP 501, adalimumab (USA) and adalimumab (EU) pharmacokinetic parameters by antidrug antibody status
| Geometrical mean (n) (GeoCV%) | tmax (hours) Median (n) (Min−Max) | t½ (hours) Mean (n) (SD) | |||
|---|---|---|---|---|---|
| Treatment | Cmax (µg/mL) | AUClast (µg·h/mL) | AUCinf (µg·h/mL) | ||
| ADAb-positive subjects | |||||
| ABP 501 | 3.24 (36) (31.5) | 1730 (36) (36.6) | 1840 (33) (27.2) | 168 (36) (71.0–312) | 151 (33) (75.1) |
| Adalimumab (USA) | 3.21 (38) (33.0) | 1730 (38) (39.8) | 1790 (36) (41.8) | 143 (38) (47.0–311) | 169 (36) (99.1) |
| Adalimumab (EU) | 3.33 (45) (31.8) | 1820 (44) (40.1) | 1820 (40) (40.9) | 168 (45) (48.0–313) | 176 (40) (96.8) |
| ADAb-negative subjects | |||||
| ABP 501 | 3.31 (31) (29.1) | 2430 (31) (31.4) | 2650 (25) (37.3) | 191 (31) (47.2–360) | 371 (25) (156) |
| Adalimumab (USA) | 3.06 (31) (32.8) | 2110 (31) (41.9) | 2130 (25) (34.8) | 167 (31) (71.1–359) | 281 (25) (122) |
| Adalimumab (EU) | 3.17 (22) (28.1) | 2360 (22) (26.9) | 2540 (17) (32.8) | 144 (22) (72.0–312) | 366 (17) (175) |
ADAb. antidrug antibody; 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; GeoCV%, geometrical mean coefficient of variation; max, maximum; min, minimum; n, number of non-missing observations; tmax, time to Cmax; t½, terminal elimination half-life.