Table 1.

Characteristics of patients with uncontrolled gout in the intent‐to‐treat population treated with pegloticase plus MTX versus pegloticase plus placebo^*

	Pegloticase plus MTX	Pegloticase plus placebo
	(n = 100)	(n = 52)
Male	91 (91.0)	44 (84.6)
Age, mean ± SD years	55.6 ± 12.7	53.0 ± 12.1
Race/ethnicity
White	69 (69.0)	36 (69.2)
Black or African American	16 (16.0)	6 (11.5)
Asian	8 (8.0)	6 (11.5)
Native Hawaiian/Pacific Islander	4 (4.0)	1 (1.9)
Other	3 (3.0)	3 (5.8)†
Tobacco use history
Never	51 (51.0)	28 (53.8)
Former	26 (26.0)	13 (25.0)
Current	23 (23.0)	11 (21.2)
Body mass index, mean ± SD kg/m2	32.7 ± 5.6	32.7 ± 7.8
Baseline eGFR, mean ± SD ml/minute/1.73 m2 ‡, §	69.3 ± 17.8	71.1 ± 17.2
eGFR <60 ml/minute/1.73 m2	33 (33.3)	16 (30.8)
Gout characteristics
Time since first gout diagnosis, mean ± SD years	13.7 ± 10.6	14.3 ± 10.8
Presence of tophi at screening¶	74 (74.0)	41 (78.8)
Number of acute gout flares in prior year, mean ± SD	10.6 ± 12.9	11.3 ± 16.7
Number of acute gout flares in prior 6 months, mean ± SD	5.5 ± 6.7	6.1 ± 8.7
Baseline serum urate, mean ± SD mg/dl‡	8.74 ± 1.61	9.11 ± 1.65
Prior oral urate‐lowering therapy use (within past year)	83 (83.0)	45 (86.5)
Allopurinol	78 (78.0)	39 (75.0)
Febuxostat	15 (15.0)	10 (19.2)
Probenecid	3 (3.0)	3 (5.8)

^*Except where otherwise indicated, values are the number (%) of patients. eGFR = estimated glomerular filtration rate.

^†Includes 1 patient with missing race/ethnicity information.

^‡Last observation made prior to first open‐label methotrexate (MTX) dose (6 weeks before first pegloticase infusion [week –6]).

^§In the safety population (≥1 pegloticase infusion received), the pegloticase plus MTX group included 95 patients, and the pegloticase plus placebo group included 49 patients.

^¶Based on investigator or photographic assessment.