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Table 2 Pegloticase Treatment Parameters and Observed Laboratory Values

From: Urate-lowering therapy, serum urate, inflammatory biomarkers, and renal function in patients with gout following pegloticase discontinuation

Characteristic

Pegloticase treatment laboratory values a

Overall (N = 375)

Post-pegloticase discontinuation laboratory values b

Post-ULT initiation laboratory values c

SU, mg/dL

(N = 253)

(N = 350)

(N = 257)

 Mean (SD)

3.0 (3.9)

5.8 (3.5)

6.1 (2.5)

 Median (IQR)

0.9 (0.2, 6.6)

5.8 (3.5, 8.3)

5.8 (4.6, 7.4)

eGFR, mL/min/1.73m2

(N = 98)

(N = 317)

(N = 233)

 Mean (SD)

74.2 (26.8)

75.8 (27.5)

77.2 (26.8)

 Median (IQR)

74.5 (54.0, 95.0)

77.5 (56.4, 96.2)

79.0 (56.5, 98.6)

CRP, mg/L

(N = 38)

(N = 110)

(N = 72)

 Mean (SD)

18.4 (27.2)

10.3 (18.1)

7.4 (12.7)

 Median (IQR)

8.0 (2.4, 24.7)

3.7 (1.4, 9.8)

3.3 (1.8, 8.2)

ESR, mm/hr

(N = 28)

(N = 67)

(N = 48)

 Mean (SD)

28.4 (24.0)

21.5 (20.2)

21.7 (18.8)

 Median (IQR)

23.5 (6.8, 46.8)

17.0 (6.0, 27.5)

18.0 (6.0, 32.3)

Pegloticase treatment

   

Pegloticase infusions

   

Median (IQR)

8.0 (3.0, 14.0)

-

-

≥ 12 pegloticase infusions, n (%)

147 (39.2)

-

-

Median (IQR) treatment length, days

112.0 (33.0, 204.5)

-

-

SU < 6 on-treatment, n (%)

185 (73.1)

-

-

N

253

-

-

Tophi, n (%)

-

257 (68.5)

-

Laboratory value changes

  
  

On-treatment to post-pegloticase discontinuation

Post-pegloticase discontinuation to post-ULT initiation

SU, mg/dL

-

(N = 252)

(N = 257)

 Mean (SD)

-

2.8 (4.6)

0.1 (3.1)

 Median (IQR)

-

2.4 (0.0, 6.3)

0.0 (-1.0, 0.5)

eGFR, mL/min/1.73m2

-

(N = 93)

(N = 233)

 Mean (SD)

-

-2.8 (11.6)

-0.6 (10.2)

 Median (IQR)

-

-1.9 (-8.7, 3.7)

0.0 (-3.7, 0.6)

CRP, mg/L

-

(N = 18)

(N = 72)

 Mean (SD)

-

-4.2 (16.6)

-1.2 (15.5)

 Median (IQR)

-

-0.8 (-12.8, 0.0)

0.0 (0.0, 0.0)

ESR, mm/hr

-

(N = 9)

(N = 48)

 Mean (SD)

-

-9.0 (11.9)

-1.2 (11.9)

 Median (IQR)

-

-4.0 (-13.0, 0.0)

0.0 (0.0, 0.0)

Target SU

   

SU < 6 post-pegloticase discontinuation, n (%)

-

181 (51.7)

-

N

-

350

-

ULT restart

   

SU < 6 after post-ULT initiation, n (%)

-

-

131 (51.0)

N

-

-

257

Time between stopping and restarting ULT, days

   

Median (IQR)

-

-

92.0 (55.0, 173.0)

N

-

-

257

  1. SD = standard deviation; IQR = interquartile range; SU = serum urate; CRP = C-reactive protein; ESR = erythrocyte sedimentation rate; eGFR = estimated glomerular filtration rate; ULT = urate-lowering therapy
  2. Note: Oral ULTs should not be administered during pegloticase treatment (including the 2-week period following the last infusion)
  3. a On-treatment lab values were limited to 1–15 days after the second pegloticase infusion
  4. b Post-pegloticase discontinuation lab values were measured 2 weeks following the index date
  5. c Post-ULT lab values were measured > = 30 days after starting a ULT drug