Table 5

Overall tophus complete response and target tophus complete response for patients in the open-label extension studya
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)

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.

Baraf et al.

Baraf et al. Arthritis Research & Therapy 2013 15:R137   doi:10.1186/ar4318

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