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Table 5 Overall tophus complete response and target tophus complete response for patients in the open-label extension study a

From: Tophus burden reduction with pegloticase: results from phase 3 randomized trials and open-label extension in patients with chronic gout refractory to conventional therapy

Visit during

Biweekly pegloticase in

Monthly pegloticase in

Placebo in RCT and

All patientsc

OLE parameterb

RCT and continued

RCT and continued

initiated pegloticase

 
 

pegloticase in OLE

pegloticase in OLE

in OLE

 

(n= 45)

(n= 42)

(n= 26)

(N= 113)

Overall CR, n/N (% patients)

Week 13 visit

17 of 36 (47)

12 of 28 (43)

7 of 16 (44)

36 of 80 (45)

Week 25 visit

20 of 31 (65)

16 of 28 (57)

11 of 15 (73)

47 of 74 (64)

Week 53 visit

21 of 29 (72)

18 of 27 (67)

11 of 12 (92)

50 of 68 (74)

Week 77 visit

17 of 27 (63)

12 of 19 (63)

10 of 11 (91)

39 of 57 (68)

Week 101 visit

3 of 5 (60)

3 of 3 (100)

2 of 2 (100)

8 of 10 (80)

Final visit

23 of 39 (59)

20 of 34 (59)

13 of 21 (62)

56 of 94 (60)

TT-CR, n/N (% tophi)

All target tophi (N = 357)

Week 13 visit

55 of 164 (34)

36 of 104 (35)

17 of 89 (19)

108 of 357 (30)

Week 25 visit

67 of 136 (49)

52 of 103 (50)

39 of 79 (49)

158 of 318 (50)

Week 53 visit

70 of 138 (51)

62 of 100 (62)

53 of 64 (83)

185 of 302 (61)

Week 77 visit

85 of 138 (62)

40 of 61 (66)

51 of 62 (82)

176 of 261 (67)

Week 101 visit

4 of 9 (44)

10 of 10 (100)

8 of 12 (67)

22 of 31 (71)

Final visit

90 of 164 (55)

68 of 121 (56)

49 of 105 (47)

207 of 390 (53)

  1. aCR, complete response; OLE, open-label extension study; RCT, randomized controlled trial; TT-CR, target tophus complete response. bValues shown are number of patients (n) with overall tophus response-CR/total number of patients (N) evaluated at the visit or number of target tophi (n) with CR/total number (N) of target tophi evaluated at the visit. cThis population included all tophus-evaluable patients at each time point, both PUA responders and nonresponders, as defined by the primary endpoint in the RCTs.