Table 2.
Relative Bioavailability of Belimumab (PK Population)
| Prefilled Syringe | Autoinjector | ||||
|---|---|---|---|---|---|
| Parameter | N | Geometric Meana | N | Geometric Mean a | Relative Bioavailability (90%CI) |
| AUC(0‐∞) (day · μg/mL) | 38 | 812 | 38 | 761 | 93.6 (83.2–105.4) |
| AUC(0‐t) (day · μg/mL) | 38 | 734 | 38 | 698 | 95.0 (85.4–105.7) |
| Cmax (μg/mL) | 38 | 26.8 | 38 | 28.2 | 105.2 (94.0–117.7) |
AUC, area under the curve; CI, confidence interval; Cmax, maximum observed serum concentration; PK, pharmacokinetic. PK population excludes the following subjects with incomplete dosing; 2, autoinjector‐abdomen; 1, autoinjector‐thigh; 2, prefilled syringe‐thigh.
a
An analysis of variance was performed on natural logarithms of PK parameters. Estimated geometric means are presented; the model included covariates of injection location and baseline body weight and has made adjustments for the geometric means for any imbalance of these variables between the 2 injection device groups.