Table 3.
Ofatumumab plasma pharmacokinetic parameter values
| Pharmacokinetic parameter | n | O-DHAP* | n | O-ICE | n | Total* |
|---|---|---|---|---|---|---|
| Cmax dose 1 (300 mg; μg/mL) | 4 | 89.8 (8) | 17 | 80.0 (63) | 21 | 81.8 (56) |
| Cmax dose 1 (1000 mg; μg/mL) | 22 | 323 (40) | 18 | 268 (30) | 40 | 297 (37) |
| Cmax cycle 3 (μg/mL) | 18 | 455 (29) | 25 | 406 (21) | 48 | 420 (25) |
| Ctrough prior to cycle 3 (μg/mL) | 22 | 146 (41) | 31 | 100 (59) | 57 | 117 (54) |
| AUC(0-504) cycle 3 (μg.h/mL) | 18 | 108 511 (21) | 19 | 91 391 (22) | 40 | 98 236 (23) |
| AUC(0-∞) cycle 3 (μg.h/mL) | 18 | 250 070 (22) | 19 | 213 514 (14) | 40 | 227 263 (20) |
| CL (mL/h) | 26 | 8.7 (15) | 35 | 9.2 (14) | 61 | 9.0 (15) |
| Vss (L) | 26 | 7.1 (38) | 35 | 8.1 (50) | 61 | 7.7 (46) |
| t1/2 (h) | 26 | 24.8 (35) | 35 | 26.9 (47) | 61 | 26.0 (42) |
Data are reported as geometric mean (%CVb). Cmax, maximum concentration; Ctrough, minimum concentration prior to next dose; O, ofatumumab; Vss, volume at a steady state; t1/2, half-life.
*
Cmax, Ctrough, and AUC values for patients crossing over from DHAP to ICE are not included in DHAP or ICE summaries after crossover but are included in the “Total” column.