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. 2019 Mar 12;134(2):123–133. doi: 10.1182/blood-2019-02-895193

Table 3.

Isatuximab PK parameters

Isatuximab (plasma)
5 mg/kg QW/Q2W 10 mg/kg QW/Q2W 20 mg/kg QW/Q2W
Cycle 1
 n 5 18 6
 Cmax, mean ± SD (geometric mean) [CV%], µg/mL 91.3 ± 19.8 (89.7) [21.7] 141 ± 18.8 (140) [13.3] 297 ± 16.7 (296) [5.6]
 tmax, median (min-max), h 2.42 (2.13-3.83) 3.41 (2.30-28.00) 5.22 (4.28-8.93)
 AUC1week, mean ± SD (geometric mean) [CV%], μg·h/mL 6100 ± 2840 (5580) [46.5] 12 800 ± 2430* (12 600) [18.9] 27 000 ± 5620 (26 500) [20.8]
Cycle 3
 n 6 24 6
 Cmax, mean ± SD (geometric mean) [CV%], µg/mL 167 ± 34.5 (164) [20.6] 403 ± 163 (375) [40.4] 648 ± 246 (611) [38.0]
 tmax, median (min-max), h 5.97 (1.83-7.25) 6.36 (2.00-23.67) 7.52 (4.25-48.17)
 AUC2weeks, mean ± SD (geometric mean) [CV%], μg·h/mL 30 900 ± 10 900 (29 000) [35.2] 71 000 ± 34 600 (63 990) [48.7] 156 000 ± 91 000 (134 000) [58.5]

Cmax, peak serum concentration; SD, standard deviation; tmax, time when peak serum concentration is reached. See Table 1 for expansion of other abbreviations.

*

n = 16.

n = 19.

n = 5.