Overall steady state PK between weeks 22 and 30
| Parameter | Treatment | n | Geometric mean | Ratio (%) of geometric means | 90% CI of ratio (%) |
|---|---|---|---|---|---|
| PK population | |||||
| AUC | CT-P13 | 112 | 32765.8 | 104.5 | 94.3 to 115.8 |
| (μgh/ml) | INX | 110 | 31359.3 | ||
| Cmax,ss | CT-P13 | 113 | 147.0 | 101.5 | 94.7 to 108.9 |
| (μg/ml) | INX | 110 | 144.8 | ||
| ADA-negative subset | |||||
| AUC | CT-P13 | 84 | 37505.2 | 103.4 | 94.6 to 113.1 |
| (μgh/ml) | INX | 86 | 36266.9 | ||
| Cmax,ss | CT-P13 | 85 | 153.9 | 104.7 | 97.2 to 112.9 |
| (μg/ml) | INX | 86 | 146.9 | ||
The primary PK endpoints of the observed AUC and Cmax,ss in patients treated with CT-P13 and INX at steady state were analysed using an analysis of covariance with treatment as a fixed effect and region and baseline BASDAI score fitted as covariates. Point estimates and 90% CI for differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale.
ADA, anti-drug antibodies; AUC, area under the concentration-time curve; Cmax,ss, observed maximum steady state serum concentration; CI, confidence interval; INX, innovator infliximab; PK, pharmacokinetics.