| COMPARE | DISSOLVE 1 | DISSOLVE 2 | |
|---|---|---|---|
| Treatment groups | SEL-212 [ImmTOR (0.15 mg/kg) and pegadricase (0.2 mg/kg)] monthly vs pegloticase 8 mg bi-weekly for six months | SEL-110 (high dose: 0.15 mg/kg and low dose: 0.1 mg/kg) +SEL-035 (0.2 mg/kg) vs placebo | SEL-110 (high and low doses) +SEL-035 vs placebo |
| Population studied | n = 170 (n = 83 for SEL-212, n = 87 for pegloticase)Patients with uncontrolled gout | n = 112 Uncontrolled gout refractory to conventional treatment (US) | n = 153 Uncontrolled gout refractory to conventional treatment (Global) |
| Efficacy | Pegadricase did not meet the primary endpoint of statistical superiority SU (serum urate) < 6 mg/dL for at least 80% of the time during months 3 and 6 combined: 59% pegadricase vs 46% pegloticase, P = 0.181Decrease in mean SU levels compared to pegloticase (P = 0.0033) | Studies met the primary efficacy endpoint of achieving and maintaining a SU < 6 mg/dL for ≥ 80% of the time during the sixth treatment period. High-dose group: 56% and 46% of pts responded to treatment; Low-dose group: 48% and 40% of pts responded to treatment | |
| AEs n (%) | 45 (54.2%) | Pooled AEs: 3.4% and 4.5% infusion reactions to high and low doses, respectively.Serious AEs: 3.4% (n = 4 anaphylaxis, n = 2 gout flares) | |
| Gout flare | 27 (32.5%) | NA | |
| Infusion-related reaction | 13 (15.7%) | NA | |
| Headache | 4 (4.8%) | NA | |
| Hypertriglyceridemia | 3 (3.6%) | NA | |
| Aphthous ulcer | 2 (2.4%) | NA | |
NA: not available; pts: patients
