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Table 3 Summary of pharmacokinetic parameters

From: Induced and pre-existing anti-polyethylene glycol antibody in a trial of every 3-week dosing of pegloticase for refractory gout, including in organ transplant recipients

Patients All PR TR P, PR vs. TR
Infusion #1     
Cmax (t = 2 h) mU/mL 25.6 ± 5.0 26.2 ± 5.9 24.7 ± 3.4 0.45 (ns)
C48h (t = 48 h) mU/mL 22.4 ± 5.6 22.9 ± 6.3 21.7 ± 4.7 0.60 (ns)
Cmin (t = 21 days) mU/mL 4.9 ± 4.6 7.7 ± 3.8 1.0 ± 2.2 <0.0001*
T1/2, days 11.4 ± 3.7a 12.3 ± 3.7 9.7 ± 3.3a 0.08 (ns)
AUC2 h-21 days, mU*mL-1*d 277 ± 112 328 ± 100 204 ± 85 0.0016*
Infusion #5     
Cmax (t = 2 h) mU/mL   31.4 ± 9 10.5 ± 12 <0.0005*
C48h (t = 48 h) mU/mL   29.9 ± 9.7 4.9 ± 7.3 <0.0001*
Cmin (t = 21 days) mU/mL   10.6 ± 5.1 0.2 <0.0003*
T1/2, days   13.8 ± 3.0 -b  
AUC2 h-21 days, mU*mL-1*d   422 44  
AUC, inf #5/inf #1   1.3 0.2  
Average for all infusions     
Cmax (t = 2 h) mU/mL   30.9 ± 2.9 16.9 ± 5.4 0.0009*
Cmin (t = 21 days) mU/mL   9.9 ± 1.4 0.4 ± 0.4 <0.0001*
T1/2, days   13.0 ± 3.4 -b  
AUC2 h-21 days, mU*mL-1*d   397 ± 38 105 ± 65 <0.0001*
  1. aT1/2 could not be calculated for three non-naive patients; therefore N = 26 (all), 17 (PR), 9 (PR); bT1/2 could not be calculated. AUC, area under the concentration curve.