Table 4. ANCOVA for the primary pharmacokinetic parameters with weight as a covariate.
| PK parameter | Treatment | N | n* | Geo-LSMean |
|---|---|---|---|---|
| AUCinf (ng×h/mL) | SB17 | 67 | 62 | 5,015,600 |
| EU-UST | 67 | 64 | 4,964,200 | |
| US-UST | 67 | 60 | 4,870,100 | |
| Cmax (ng/mL) | SB17 | 67 | 62 | 4,977 |
| EU-UST | 67 | 64 | 5,332 | |
| US-UST | 67 | 60 | 5,119 | |
| PK parameter | Comparison | Ratio | 90% CI of ratio | |
| AUCinf (ng×h/mL) | SB17/EU-UST | 1.01 | [0.92, 1.11] | |
| SB17/US-UST | 1.02 | [0.94, 1.12] | ||
| EU-UST/US-UST | 1.00 | [0.92, 1.10] | ||
| Cmax (ng/mL) | SB17/EU-UST | 0.93 | [0.85, 1.02] | |
| SB17/US-UST | 0.96 | [0.88, 1.05] | ||
| EU-UST/US-UST | 1.02 | [0.94, 1.12] | ||
ANCOVA = analysis of covariance; AUCinf = area under the concentration-time curve from time zero to infinity; Cmax = maximum serum concentration; CI = confidence interval; EU-UST = EU-sourced ustekinumab; Geo-LSMean = geometric least squares mean; N = number of subjects in the PK analysis set; n = number of subjects in the analysis; PK = pharmacokinetic; SB17 = ustekinumab biosimilar candidate; US-UST = US-sourced ustekinumab. *In total, 15 subjects were excluded from the ANOVA analysis (13 due to COVID-19, 1 due to the discretion of the investigator, and 1 due to withdrawal of informed consent).