Table 4.
Simulated Measures of Exposure for Additional Dosing Regimens
| Regimen | Day/type | AUC0–τ (μg · h/mL) | Cmax (μg/mL) | Ctrough (ng/mL) |
|---|---|---|---|---|
| 300 mg QW | 1 | 84.4 (77.6–91.6) | 6.35 (5.61–7.17) | 5.62 (4.92–6.24) |
| 300 mg QOW | 1 | 85.5 (78.4–92.5) | 6.33 (5.66–7.18) | 4.28 (3.82–4.74) |
| Loading + 300 mg QW | 1 | 85.5 (78.5–92.8) | 6.36 (5.76–7.26) | 25.7a (20.9–31.8) |
| 150 mg QW | 1 | 42.3 (38.8–45.9) | 3.16 (2.81–3.57) | 2.81 (2.45–3.11) |
| 300 mg QW | 449 | 89.9 (82.4–97.4) | 6.39 (5.65–7.20) | 34.3 (31.0–38.2) |
| 300 mg QOW | 449 | 90.1 (82.6–97.5) | 6.34 (5.67–7.20) | 14.8 (13.3–16.8) |
| Loading + 300 mg QW | 449 | 90.0 (82.8–97.8) | 6.34 (5.72–7.24) | 34.3 (30.6–38.3) |
| 150 mg QW | 449 | 45.0 (41.4–48.8) | 3.18 (2.83–3.59) | 17.2 (15.5–19.1) |
| 300 mg QW | AR | 1.06 (1.06–1.07) | 1.01 (1.00–1.01) | 6.11 (5.26–7.30) |
| 300 mg QOW | AR | 1.05 (1.05–1.06) | 1.00 (1.00–1.00) | 3.45 (2.99–4.08) |
| Loading + 300 mg QW | AR | 1.05 (1.05–1.06) | 0.996 (0.991–0.999) | NA |
| 150 mg QW | AR | 1.06 (1.06–1.07) | 1.01 (1.00–1.01) | 6.14 (5.27–7.26) |
Data presented are geometric mean (90% CI).
a
Ctrough after the dose on day 1 is 48 h time point during loading dose period.
AUC, area under cureve; QW, once weekly; QOW, once every other week; AR, accumulation ratio.