Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial

摘要: Objective. To evaluate the efficacy and safety of IL-1 inhibitor rilonacept (IL-1 Trap) for gout flare (GF) prevention during initiation uric acid-lowering therapy (ULT) with allopurinol in a multiregional phase 3 clinical trial. Methods. Hyperuricaemic adults (n = 248) from South Africa, Germany Asia two or more GFs within past year were initiated on randomized 1:1:1 to once-weekly s.c. treatment placebo (PBO), 80 mg (R80) 160 (R160) 16 weeks. The primary endpoint was number per patient through week 16. Results. population predominantly male racially diverse (white, 53.2%; Asian, 33.1%; black, 13.7%). Across treatments, most patients completed study (87.892.9%). At weeks mean reduced by 71.3% R80 (0.35) 72.6% R160 (0.34) relative PBO (1.23; both P 70% having no flares, demonstrated an acceptable tolerability profile.