Table 3.
Non-compartmental pharmacokinetic parameters of mavrilimumab in subjects with mild to moderate rheumatoid arthritis
| Mavrilimumab dose (mg/kg) | |||||||
|---|---|---|---|---|---|---|---|
| Pharmacokinetic parameter | 0.01 (n = 1) | 0.03 (n = 1) | 0.1 (n = 5) | 0.3 (n = 5) | 1.0 (n = 5) | 3.0 (n = 5) | 10.0 (n = 4) |
| Cmax (μg/ml) | 0.241 | 0.550 | 2.95 (0.87) | 6.72 (1.43) | 26.8 (4.69) | 81.4 (23.6) | 373 (38) |
| AUCinf (μg∙day/ml) | 0.113 | 0.781 | 5.01 (1.72) | 25.4 (9.1) | 147 (42) | 706 (429) | 3200 (290) |
| CL (ml/kg/day) | 88.8 | 38.4 | 21.6 (6.1) | 13.1 (4.6) | 7.23 (2.07) | 5.19 (2.06) | 3.15 (0.31) |
| t1/2 (day) | 1.51 | 2.13 | 1.81 (0.59) | 2.55 (0.21) | 4.78 (0.66) | 7.59 (1.83) | 15.1 (3.6) |
Parameter values are shown as mean (SD) except for the 0.01 mg/kg and 0.03 mg/kg dose levels. Data from the subject who received partial infusion in the 10.0 mg/kg cohort were excluded from the analysis.
AUCinf, area under the concentration–time curve extrapolated to infinity; CL, systemic clearance; Cmax, maximum observed concentration; t1/2, elimination half-life.