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

Table 3 Summary of pharmacokinetic parameters

*Patients*	All	PR	TR	P, PR vs. TR
*Infusion #1*
C_max (t = 2 h) mU/mL	25.6 ± 5.0	26.2 ± 5.9	24.7 ± 3.4	0.45 (ns)
C_48h (t = 48 h) mU/mL	22.4 ± 5.6	22.9 ± 6.3	21.7 ± 4.7	0.60 (ns)
C_min (t = 21 days) mU/mL	4.9 ± 4.6	7.7 ± 3.8	1.0 ± 2.2	<0.0001*
T_1/2, days	11.4 ± 3.7^a	12.3 ± 3.7	9.7 ± 3.3^a	0.08 (ns)
AUC_{2 h-21 days}, mUmL^-1d	277 ± 112	328 ± 100	204 ± 85	0.0016*
*Infusion #5*
C_max (t = 2 h) mU/mL		31.4 ± 9	10.5 ± 12	<0.0005*
C_48h (t = 48 h) mU/mL		29.9 ± 9.7	4.9 ± 7.3	<0.0001*
C_min (t = 21 days) mU/mL		10.6 ± 5.1	0.2	<0.0003*
T_1/2, days		13.8 ± 3.0	-^b
AUC_{2 h-21 days}, mUmL^-1d		422	44
AUC, inf #5/inf #1		1.3	0.2
*Average for all infusions*
C_max (t = 2 h) mU/mL		30.9 ± 2.9	16.9 ± 5.4	0.0009*
C_min (t = 21 days) mU/mL		9.9 ± 1.4	0.4 ± 0.4	<0.0001*
T_1/2, days		13.0 ± 3.4	-^b
AUC_{2 h-21 days}, mUmL^-1d		397 ± 38	105 ± 65	<0.0001*

^aT_1/2 could not be calculated for three non-naive patients; therefore N = 26 (all), 17 (PR), 9 (PR); ^bT_1/2 could not be calculated. AUC, area under the concentration curve.

ISSN: 1478-6362