Table 2

Overall steady state PK between weeks 22 and 30

ParameterTreatmentnGeometric meanRatio (%) of geometric means90% CI of ratio (%)
PK population
 AUCCT-P1311232765.8104.594.3 to 115.8
 Cmax,ssCT-P13113147.0101.594.7 to 108.9
ADA-negative subset
 AUCCT-P138437505.2103.494.6 to 113.1
 Cmax,ssCT-P1385153.9104.797.2 to 112.9
  • 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.