Table 3.
Simulated PK metrics from phase 3 studies of secukinumab
| Secukinumab 300‐mg Regimen | Secukinumab 150‐mg Regimen | |||||
|---|---|---|---|---|---|---|
| Parameter | Mean ± SD | %CV | Range (90%) | Mean ± SD | %CV | Range (90%) |
| Cmin at week 12, μg/mL | 44.2 ± 20.6 | 46.5 | 17.5–83.0 | 22.1 ± 10.3 | 46.5 | 8.7–41.5 |
| Cmin at ss, μg/mL | 32.1 ± 15.4 | 48 | 12.9–62.9 | 16.0 ± 7.7 | 48 | 6.5–31.5 |
| Cavg at ss, μg/mL | 44.5 ± 18.4 | 41.3 | 21.1–77.9 | 22.2 ± 9.2 | 41.3 | 10.5–39.0 |
| AUC at ss, μg·day/mL | 1245.0 ± 514.8 | 41.3 | 590.4–2181.7 | 622.5 ± 257.4 | 41.3 | 295.2–1090.8 |
| Cmax after first dose, μg/mL | 27.3 ± 9.5 | 34.8 | 14.2–44.6 | 13.7 ± 4.8 | 34.8 | 7.1–22.3 |
| tmax after first dose, day | 5.8 ± 0.4 | 7.6 | 5.0–6.0 | 5.8 ± 0.4 | 7.6 | 5.0–6.0 |
| Cmax at ss, μg/mL | 55.2 ± 21.5 | 38.9 | 27.5–94.8 | 27.6 ± 10.7 | 38.9 | 13.7–47.4 |
| tmax at ss, day | 6.0 ± 1.1 | 17.7 | 4.0–8.0 | 6.0 ± 1.1 | 17.7 | 4.0–8.0 |
| Cmax overall, μg/mL | 103.7 ± 33.5 | 32.3 | 59.5–165.5 | 51.8 ± 16.7 | 32.3 | 29.8–82.8 |
| tmax overall, day | 32.3 ± 1.1 | 3.3 | 31.0–34.0 | 32.3 ± 1.1 | 3.3 | 31.0–34.0 |
| Terminal half‐life, day | 26.9 ± 7.3 | 27.2 | 16.8–41.0 | 26.9 ± 7.3 | 27.2 | 16.8–41.0 |
AUC, area under the curve; Cavg, average concentration in serum; Cmax, maximum concentration in serum; Cmin, minimum concentration in serum; CV, coefficient of variation; PK, pharmacokinetic; SD, standard deviation; ss, steady state; Tmax, time to maximum concentration in serum.