Table 2.

Mean ± SD PK parameter estimates (per‐protocol population)

	PF‐05280586	Rituximab‐EU	Rituximab‐US
	n = 68	n = 67	n = 63
C max, μg ml–1	453 ± 153	422 ± 111	430 ± 163
AUC2‐week, μg·h ml–1	52, 100 ± 18, 000	49, 600 ± 14, 200	49, 200 ± 15, 900
AUCT, μg·h ml–1 †	198, 000 ± 79, 600	188, 000 ± 64, 300	196, 000 ± 78, 300
AUC0‐∞, μg·h ml–1 ‡	213, 000 ± 90, 400	200, 000 ± 74,600	214, 000 ± 95, 300*
CL, ml h–1 kg–1	11.2 ± 4.91	11.4 ± 4.55	11.3 ± 4.87*
V ss, ml kg–1	5490 ± 1740	5590 ± 1320	5810 ± 1590*
t ½, h	434 ± 142	424 ± 125	456 ± 145*

AUC_2‐week, area under the serum concentration–time curve from time 0 to 2 weeks; AUC_T, area under the serum concentration–time curve from time 0 to the last time point with a quantifiable concentration; AUC_0–∞, area under the serum concentration–time curve from time 0 extrapolated to infinite time; CL, clearance; C _max, maximum serum concentration; PK, pharmacokinetic; SD, standard deviation; t _½, terminal elimination half‐life; V _ss, volume of distribution at steady‐state.

^* n = 62 as one patient missed multiple samples, for whom the terminal phase could not be determined adequately.

^† AUC_T was estimated based on the 12‐week concentration–time data. When the additional drug concentration samples collected on day 169 were included in the calculation, the mean (±SD) values of AUC_T were 209,000 ± 87, 800 μg·h ml^–1, 198, 000 ± 70, 800 μg·h ml^–1 and 209, 000 ± 89, 800 μg·h ml^–1 for PF‐05280586, rituximab‐EU and rituximab‐US, respectively.

^‡ AUC_0–∞ was estimated based on the 12‐week concentration–time data. When the additional drug concentration samples collected on day 169 were included in the calculation, the mean (±SD) values of AUC_0–∞ were 213, 000 ± 89, 600 μg·h ml^–1, 200, 000 ± 72, 500 μg·h ml^–1 and 214, 000 ± 94, 000 μg·h ml^–1 for PF‐05280586, rituximab‐EU and rituximab‐US, respectively.