Table 3.
Comparison of pharmacokinetic parameters for tabalumab by dose group in subjects with RA or SLE following intravenous administration in study A*
| Tabalumab dose | ||||
|---|---|---|---|---|
| 0.125 mg kg –1 | 2.0 mg kg –1 | |||
| RA (n = 3) | SLE (n = 3) | RA (n = 3) | SLE (n = 2) † | |
| C max (ng ml –1 ) | 3290 (19.2) | 3350 (75.8) | 63 400 (15.5) | 63 200, 83 400 |
| AUC ( 0, ∞) (ng ml –1 day) | 21 300 (38.5) | 23 800 (48.6) | 1 090 000 (7.57) | 1 020 000, 1 710 000 |
| CL (l day –1 ) | 0.392 (37.4) | 0.349 (41.2) | 0.112 (23.1) | 0.164, 0.110 |
| V ss (l) | 6.07 (80.0) | 3.01 (26.4) | 3.54 (16.5) | 3.60, 3.39 |
| t 1/2 ‡ (days) | 5.77 (3.28–10.0) | 5.57 (4.45–6.54) | 20.1 (18.5–23.0) | 13.9, 17.5 |
*
Values are geometric mean (CV%) unless otherwise indicated.
†
Individual values.
‡
Geometric mean (range).
AUC(0,∞), area under the concentration–time curve from zero to infinity; CL, total body clearance of drug after intravenous administration; C max, maximum observed drug concentration; CV%, coefficient of variation expressed as a percentage; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus; t 1/2, half‐life associated with the terminal rate constant; V ss, volume of distribution at steady‐state.