Table 2.
Parameter
Week |
CT-P13 s.c.
(n = 166) |
CT-P13 i.v.
(n = 174) |
||
---|---|---|---|---|
n | Mean (CV%) | n | Mean (CV%) | |
AUCτ, h·µg/ml | ||||
22 | 162 | 5311.5 (45.6) | 165 | 14,156.9 (46.3) |
24 | 160 | 5187.9 (45.3) | N/A | N/A |
26 | 161 | 5273.1 (47.3) | N/A | N/A |
28 | 160 | 5157.2 (46.6) | N/A | N/A |
AUCW22–30, h·µg/ml | ||||
22 | 162 | 20,926.6 (45.4) | N/A | N/A |
Cmax, µg/ml | ||||
22 | 162 | 17.74 (40.87) | 165 | 71.60 (16.89) |
24 | 160 | 17.62 (40.73) | N/A | N/A |
26 | 161 | 17.63 (41.10) | N/A | N/A |
28 | 160 | 17.54 (40.63) | N/A | N/A |
Ctrough, µg/ml | ||||
22 | 162 | 12.19 (54.25) | 165 | 1.49 (168.41) |
24 | 160 | 12.30 (53.96) | N/A | N/A |
26 | 161 | 12.18 (53.42) | N/A | N/A |
28 | 160 | 12.17 (54.58) | N/A | N/A |
PK parameters (AUCτ, Cmax and Ctrough) were estimated from population PK modelling, and AUCW22–30 for the CT-P13 s.c. arm was estimated due to the different dosing interval of s.c. and i.v. administration [every 2 weeks (W6–28) and every 8 weeks (W6, W14 and W22), respectively]. bAnalysed according to actual treatment received. AUCτ, model-predicted area under the concentration–time curve at steady-state between W22 and W30; AUCW22–30, model-predicted area under the concentration–time curve due to different dosing interval of s.c. and i.v. administration using population PK model; Cmax, model-predicted maximum serum concentration after study drug administration; Ctrough, model-predicted trough serum concentration; CV%, per cent coefficient of variation; N/A, not applicable; PK, pharmacokinetic; W, week.