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. 2020 Nov 23;60(5):2277–2287. doi: 10.1093/rheumatology/keaa580

Table 2.

Predicted PK parametersa for CT-P13 s.c. and CT-P13 i.v. (PK populationb)

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
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.