Table 3. Statistical comparison of primary pharmacokinetic parameters between treatment groups.
| PK parameter | Treatment | N | n* | Geo-LSMean |
|---|---|---|---|---|
| AUCinf (ng×h/mL) | SB17 | 67 | 62 | 4,958,100 |
| EU-UST | 67 | 64 | 5,020,000 | |
| US-UST | 67 | 60 | 4,900,400 | |
| Cmax (ng/mL) | SB17 | 67 | 62 | 4,882 |
| EU-UST | 67 | 64 | 5,433 | |
| US-UST | 67 | 60 | 5,169 | |
| PK Parameter | Comparison | Ratio | 90% CI of Ratio | |
| AUCinf (ng×h/mL) | SB17/EU-UST | 0.99 | [0.90, 1.08] | |
| SB17/US-UST | 1.01 | [0.93, 1.10] | ||
| EU-UST/US-UST | 1.02 | [0.93, 1.12] | ||
| Cmax (ng/mL) | SB17/EU-UST | 0.90 | [0.82, 0.98] | |
| SB17/US-UST | 0.94 | [0.86, 1.04] | ||
| EU-UST/US-UST | 1.05 | [0.96, 1.15] | ||
AUCinf = area under the concentration-time curve from time zero to infinity; Cmax = maximum serum concentration; CI = confidence interval; N = number of subjects in the PK analysis set; n = number of subjects in the analysis; EU-UST = EU-sourced ustekinumab; Geo-LSMean = geometric least squares mean; 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).