Table 2. Summary statistics of pharmacokinetic parameters.
| PK parameter | Statistics | SB17 N = 62 |
EU-UST N = 64 |
US-UST N = 60 |
|---|---|---|---|---|
| AUCinf (ng×h/mL) | Mean (SD) | 5,143,600 (1,401,400) | 5,273,000 (1,649,100) | 5,116,600 (1,526,800) |
| Median (Min – Max) | 4,969,900 (2,414,000 – 8,884,000) | 5,305,400 (2,045,000 – 10,280,000) | 4,918,500 (2,118,000 – 10,200,000) | |
| Cmax (ng/mL) | Mean (SD) | 5,095 (1,498) | 5,689 (1,877) | 5,420 (1,659) |
| Median (Min – Max) | 5,045 (2,630 – 9,030) | 5,480 (2,950 – 13,700) | 5,400 (1,590 – 11,100) | |
| AUClast (ng×h/mL) | Mean (SD) | 4,721,000 (1,262,300) | 4,853,500 (1,431,100) | 4,769,900 (1,336,800) |
| Median (Min – Max) | 4,642,600 (2,302,000 – 8,526,000) | 4,993,000 (1,974,000 – 9,786,000) | 4,644,100 (1,959,000 – 9,257,000) | |
| AUC0–264h (ng×h/mL) | Mean (SD) | 1,044,800 (325,730) | 1,148,200 (365,750) | 1,117,700 (355,820) |
| Median (Min – Max) | 1,039,000 (458,500 – 1,780,000) | 1,104,500 (565,500 – 2,820,000) | 1,105,300 (291,500 – 2,042,000) | |
| tmax (h) | Median (Min – Max) | 168.000 (48.00 – 672.00) | 168.000 (12.00 – 504.00) | 168.000 (48.00 – 1,008.00) |
| Vz/F (mL) | Mean (SD) | 7,561.0 (2,312.5) | 7,149.3 (1,744.3) | 7,240.6 (2,241.5) |
| Median (Min – Max) | 7,250.2 (2,817 – 12,910) | 6,945.2 (2,825 – 11,560) | 6,941.4 (3,207 – 17,980) | |
| λz (1/h) | Mean (SD) | 0.0013891 (0.00084317) | 0.0014051 (0.00083473) | 0.0013624 (0.00035215) |
| Median (Min – Max) | 0.0011864 (0.0007264 – 0.005569) | 0.0012144 (0.0007386 – 0.007060) | 0.0012921 (0.0007192 – 0.002264) | |
| T1/2 (h) | Mean (SD) | 582.70 (171.00) | 563.80 (161.55) | 541.07 (134.93) |
| Median (Min – Max) | 584.24 (124.5 – 954.2) | 571.09 (98.2 – 938.4) | 536.46 (306.1 – 963.8) | |
| CL/F (mL/h) | Mean (SD) | 9.4308 (2.7416) | 9.4592 (3.3800) | 9.6075 (3.0698) |
| Median (Min – Max) | 9.0546 (5.065 – 18.64) | 8.4819 (4.378 – 22.01) | 9.1494 (4.411 – 21.25) | |
| %AUCextrap | Mean (SD) | 7.91 (5.00) | 7.40 (3.73) | 6.32 (3.18) |
| Median (Min – Max) | 6.41 (1.4 – 30.2) | 6.69 (1.6 – 18.5) | 5.52 (2.2 – 14.9) |
AUC0–264h = AUC from time zero to 264 hours; AUClast = AUC from time zero to the last quantifiable concentration; AUCinf = area under the concentration-time curve from time zero to infinity; Cmax = maximum serum concentration; CL/F = apparent clearance; EU-UST = EU-sourced ustekinumab; Min = minimum; Max = maximum; N = number of subjects for the assessment parameter; PK = pharmacokinetic; SB17 = ustekinumab biosimilar candidate; SD = standard deviation; T1/2 = terminal half-life; tmax = time to reach Cmax; US-UST = US-sourced ustekinumab; Vz/F = apparent volume of distribution during the terminal phase; λz = terminal rate constant; %AUCextrap = percentage of AUCinf due to extrapolation from time of last measurable concentration to infinity. Median and Min-Max range were summarized for tmax. Samples with low-speed centrifuge issue were excluded from PK parameters calculation. Refer to Pharmacokinetic evaluation of Results section.