Table 2.
Statistical analysis of mirikizumab pharmacokinetic parameters after subcutaneous injection of mirikizumab 200 mg administered by prefilled syringe or autoinjector (Study AMBW)
| Parameter | Device | Geometric mean (geometric %CV)a | Geometric LSM | Ratio of geometric LSM (AI:PFS) (90% CI) |
|---|---|---|---|---|
| Cmax (μg/mL) | PFS | 14.3 (44) | 14.4 | 1.06 (0.98–1.14) |
| Autoinjector | 15.2 (40) | 15.2 | ||
| AUC0–∞ (μg·day/mL) | PFS | 246 (44) | 247 | 1.06 (0.98–1.15) |
| Autoinjector | 262 (39) | 262 | ||
| AUC0–tlast (μg·day/mL) | PFS | 244 (44) | 245 | 1.05 (0.97–1.14) |
| Autoinjector | 257 (39) | 257 | ||
| tmax (day), median (min, max) | PFS | 4.00 (1.81–10.23) | – | – |
| Autoinjector | 4.00 (1.83–7.05) | – | – | |
| t1/2 (day), geometric mean (min, max) | PFS | 10.9 (4.59–20.5) | – | – |
| Autoinjector | 11.1 (6.09–21.3) | – | – | |
| CL/F (L/day) | PFS | 0.813 (44) | – | – |
| Autoinjector | 0.764 (39) | – | – | |
| Vz/F (L) | PFS | 12.8 (37) | – | – |
| Autoinjector | 12.2 (35) | – | – |
AI autoinjector, AUC0–∞ area under the concentration versus time curve from time zero to infinity, AUC0–tlast area under the concentration versus time from time zero to time t, where t is the last time point with a measurable concentration, CI confidence interval, CL/F apparent total body clearance of drug calculated after extravascular administration, Cmax maximum observed drug concentration, CV coefficient of variation, LSM least squares mean, max maximum, min minimum, PFS prefilled syringe, t1/2 half-life associated with the terminal rate constant in noncompartmental analysis, tmax time of maximum observed drug concentration, Vz/F apparent volume of distribution during the terminal phase after extravascular administration
aExcept where noted