Mean (CV) Serum pharmacokinetic parameters of INX: pharmacokinetic population
| Parameter | CT-P13 (N=113) | INX (N=110) | ||
|---|---|---|---|---|
| Dose 1 (Week 0) | ||||
| Cmax (µg/ml) | n=109 | 155.8 (37.2) | n=107 | 145.3 (25.3) |
| Cmin (µg/ml) | n=109 | 29.1 (40.1) | n=108 | 29.8 (40.8) |
| Tmax (h) | n=109 | 2.0 (1.9, 3.2) | n=107 | 2.1 (2.0, 3.5) |
| Dose 2 (Week 2) | ||||
| Cmax (µg/ml) | n=112 | 175.6 (20.9) | n=108 | 181.4 (23.8) |
| Cmin (µg/ml) | n=110 | 20.1 (56.1) | n=108 | 22.8 (72.0) |
| Tmax (h) | n=112 | 2.1 (1.8, 3.1) | n=108 | 2.1 (1.8, 3.2) |
| Dose 3 (Week 6) | ||||
| Cmax (µg/ml) | n=113 | 172.3 (26.8) | n=110 | 166.3 (22.8) |
| Cmin (µg/ml) | n=112 | 6.9 (80.2) | n=110 | 7.1 (77.6) |
| Tmax (h) | n=113 | 2.1 (2.0, 3.2) | n=110 | 2.1 (2.0, 3.2) |
| Dose 4 (Week 14) | ||||
| Cmax (µg/ml) | n=113 | 158.4 (24.0) | n=110 | 153.6 (27.5) |
| Cmin (µg/ml) | n=112 | 4.5 (83.6) | n=110 | 4.8 (75.2) |
| Tmax (h) | n=113 | 3.0 (2.0, 3.3) | n=110 | 2.1 (2.0, 4.8) |
| Dose 5 (Week 22) | ||||
| Cav,ss (µg/ml) | n=111 | 26.0 (34.2) | n=110 | 25.7 (45.7) |
| Cmin,ss (µg/ml) | n=108 | 4.2 (139.5) | n=108 | 3.6 (88.1) |
| Swing | n=108 | 102.9 (108.1) | n=108 | 108.8 (100.7) |
| Degree of fluctuation | n=108 | 6.2 (33.9) | n=108 | 6.8 (50.0) |
| Mean residence time (h) | n=103 | 353.7 (38.1) | n=98 | 368.2 (37.3) |
| T1/2 (h) | n=103 | 292.5 (32.2) | n=98 | 298.3 (32.9) |
| Tmax (h) | n=113 | 3.0 (2.0, 359.1) | n=110 | 3.0 (2.0, 168.0) |
| CLss(ml/h) | n=111 | 12.7 (73.1) | n=110 | 14.2 (77.7) |
| Vss (ml) | n=103 | 3830.8 (30.8) | n=98 | 4294.9 (78.3) |
| Dose 6 (Week 30) | ||||
| Cmax (µg/ml) | n=108 | 152.8 (31.9) | n=108 | 147.8 (26.4) |
| Tmax (h) | n=108 | 2.1 (1.9, 3.3) | n=108 | 2.2 (2.0, 4.0) |
Tmax was reported as median (minimum, maximum).
Cmax and Tmax were set to missing if the highest concentrations in the profiles occurred at time zero.
Cmax was set to missing if the concentration was below the lower limit of quantification or the same as other concentrations.
Cmax, maximum serum concentration; Cav,ss, average concentration at steady state; CLss, total clearance at steady state; Cmin, minimum concentration immediately before the next application; Cmin,ss, minimum concentration immediately before the next application at steady state; CV, coefficient of variation; INX, innovator infliximab; MRT, mean residence time; T1/2, terminal elimination half-life; Tmax, time to reach Cmax; Vss, volume of distribution at steady state.