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Table 2 Descriptive summary of plasma tofacitinib pharmacokinetic parameter values by cohort

From: Pharmacokinetic and safety profile of tofacitinib in children with polyarticular course juvenile idiopathic arthritis: results of a phase 1, open-label, multicenter study

Parameter Cohort 1
(12 to < 18 years)
N = 8a
Cohort 2
(6 to < 12 years)
N = 9b
Cohort 3
(2 to < 6 years)
N = 9
All patients
(2 to < 18 years)
N = 26c
Dose, median (range), mg BID 5.0 (3.0–5.0) 2.5 (2.0–5.0) 3.0 (2.5–3.5) 3.0 (2.0–5.0)
AUCtau, geometric mean (%CV),d ng•h/mL 156.6 (25) 118.8 (27) 142.5 (32) 138.6 (30)
Cmax, geometric mean (%CV),d ng/mL 47.0 (40) 41.7 (29) 66.2 (28) 50.7 (38)
Tmax, median (range), h 0.8 (0.5–6.9) 1.0 (0.5–2.1) 0.5 (0.5–1.9) 0.9 (0.5–6.9)
Ctrough, geometric mean, (%CV),d ng/mL 2.7 (100) 0.8 (127) 0.8 (119) 1.1 (145)
Cmin, geometric mean, (%CV),d ng/mL 2.5 (86) 0.8 (95) 0.7 (103) 1.1 (123)
t½, arithmetic mean (SD), h 2.6 ± 0.5 1.9 ± 0.3 1.8 ± 0.4 2.1 ± 0.5
CL/F, geometric mean, (%CV),d L/h 28.1 (22) 25.5 (40) 20.5 (33) 24.3 (34)
Vz/F, geometric mean, (%CV),d L 104.9 (35) 71.0 (40) 51.4 (34) 70.5 (47)
  1. %CV percent coefficient of variation, AUC tau area under the plasma concentration–time curve from time zero to time tau, CL/F apparent systemic clearance, C max maximum observed plasma concentration during the dosing interval, C min lowest observed plasma concentration during the dosing interval, C trough trough (pre-dose) concentration, N number of patients in each cohort, SD standard deviation, t 1/2 terminal phase half-life, T max time to peak plasma concentration, V z /F apparent volume of distribution
  2. a N = 7 for t½ and Vz/F due to lack of a well-characterized terminal phase in 1 patient
  3. b N = 8 for t½, Vz/F, CL/F, Cmin, and AUCtau due to incomplete pharmacokinetics sampling for 1 patient
  4. c N = 24 for t½ and Vz/F, and N = 25 for Cmin. AUCtau, and CL/F due to the exceptions noted above
  5. dGeometric %CV