Table 1.
Summary of Serum PK Parameters of Belimumab (PK Population)
| By Injection Device Only | By Injection Device and Injection Site | ||||||
|---|---|---|---|---|---|---|---|
| Parameter (Unit) | Prefilled Syringe (n = 38) | Autoinjector (n = 38) | Prefilled Syringe‐Abdomen (n = 20) | Autoinjector‐Abdomen (n = 18) | Prefilled Syringe‐Thigh (n = 18) | Autoinjector‐Thigh (n = 20) | |
| AUC0–t (day · μg/mL) | Geometric | 676 (34.1) | 652 (32.6) | 631 (35.6) | 619 (23.3) | 729 (31.5) | 684 (39.3) |
| mean (CVb%) | |||||||
| Mean (SD) | 711 (228) | 684 (216) | 667 (227) | 634 (146) | 761 (226) | 729 (259) | |
| AUC0– ∞ (day · μg/mL) | Geometric | 735 (39.9) | 701 (35.7) | 683 (41.8) | 672 (25.1) | 798 (37.1) | 728 (43.8) |
| mean (CVb%) | |||||||
| Mean (SD) | 790 (309) | 743 (261) | 738 (306) | 692 (170) | 847 (311) | 789 (319) | |
| Cmax (μg/mL) | Geometric | 25.3 (33.2) | 27.0 (31.2) | 24.1 (32.6) | 25.3 (25.3) | 26.7 (33.9) | 28.6 (35.3) |
| mean (CVb%) | |||||||
| Mean (SD) | 26.6 (8.07) | 28.2 (8.28) | 25.3 (7.71) | 26.1 (6.35) | 28.1 (8.42) | 30.1 (9.45) | |
| tmax (h) | Median | 141 | 96.8 | 134 | 108 | 141 | 96.8 |
| (min, max) | (47.5, 337) | (47.4, 238) | (68.0, 337) | (47.7, 168) | (47.5, 239) | (47.4, 238) | |
| t1/2 (h) | Geometric | 390 (42.8) | 356 (35.9) | 375 (45.7) | 355 (36.9) | 407 (40.2) | 357 (36.1) |
| mean (CVb%) | |||||||
| Mean (SD) | 424 (184) | 378 (134) | 411 (191) | 378 (144) | 438 (180) | 378 (127) | |
AUC, area under the curve; Cmax, maximum observed serum concentration; CVb, between‐subject coefficient of variation; PK, pharmacokinetic; SD, standard deviation; tmax, time to maximum serum concentration; t1/2, elimination half‐life.
All data presented to 3 significant figures.