Mean ( ± SD) change in SF-36 domain scores from baseline to Week 25. Shaded area shows changes in domain scores that are greater than or equal to minimum clinically important differences.
| Domain | PF | RP | BP | GH | VT | SF | RE | MH |
|---|---|---|---|---|---|---|---|---|
| Pegloticase biweekly, n = 61†† | 11.8*† (24.1) | 15.4*† (27.8) | 24.3*† (25.5) | 7.7* (17.5) | 9.9* (20.1) | 13.5*† (28.9) | 8.2 (30.6) | 10.1 (19.2) |
| Pegloticase monthly, n = 63†† | 9.5* (20.3) | 10.5* (28.6) | 17.9* (24.2) | 4.7 (17.2) | 4.3 (20.1) | 8.9 (26.5) | 4.6 (30.3) | 1.4 (16.8) |
| Placebo, n = 38†† | 0.25 (18.97) | 1.15 (20.90) | −1.13 (20.77) | 0.26 (14.97) | 0.33 (15.24) | 2.63 (23.99) | 4.61 (22.40) | 4.3 (18.1) |
↵* p values < 0.05 based on independent-groups t tests of means for treatment groups compared to placebo.
↵† Approached or met age/sex-matched normative values.
↵†† Number of subjects at Week 25; only patients with complete data through Week 25 are included in this analysis. BP: bodily pain; GH: general health; MH: mental health; PF: physical functioning; RE: role emotional; RP: role physical; SF: social functioning; VT: vitality.