Schumacher HR et al. – Rilonacept markedly reduced the occurrence of gout flares (GFs) associated with initiation of uric acid–lowering therapy (ULT). The efficacy and safety profile suggest that rilonacept may have the potential to improve long–term disease control for some patients by improving adherence to ULT therapy by reducing flares during the first months after ULT initiation.Methods
- 241 adult patients with gout, ≥2 GFs within the past year, and serum urate ≥7.5 mg/dL were initiated on allopurinol 300 mg daily and randomly allocated 1:1:1 to receive 16 once–weekly subcutaneous injections of placebo, rilonacept 80mg (R80), or rilonacept 160mg (R160), with a double (loading) dose on Day 1.
- Allopurinol was titrated to achieve serum urate <6.0 mg/dL.
- The study was powered for the primary efficacy endpoint, number of GFs per patient through Week 16.
- More patients in the rilonacept groups (R80 80.0%, R160 86.4%) completed the study than in the placebo group (72.5%)(P<0.05 for R160 versus placebo).
- Over 16 weeks, mean number of GFs per patient was significantly reduced by rilonacept treatment (placebo 1.06,R80 0.29 [P<0.001], R160 0.21 [P<0.001]).
- Significantly lower proportions of patients reported 1 or more GFs with R80 (18.8%) and R160 (16.3%) relative to placebo (46.8%) (both P<0.001).
- Except for injection site reactions (1.3% placebo vs 8.8% R80 [P=0.0635, post–hoc analysis] and 19.8% R160 [P=0.0001, post–hoc analysis]), the incidence of adverse events was generally balanced among treatment groups.