Background The IL-1 antagonist rilonacept demonstrated efficacy for gout flare (GF) prevention in patients (pts) initiating uric acid-lowering therapy (ULT) in two phase 3 trials of similar design (PRE-SURGE 1 and PRE-SURGE 2).
Objectives To evaluate the efficacy and safety of subcutaneous rilonacept for GF prevention in various patient subpopulations using pooled data from these trials.
Methods In both trials, pts with serum urate ≥7.5 mg/dL and ≥2 GFs within the past year who were initiating allopurinol were randomized to weekly treatment with rilonacept 80mg (R80), rilonacept 160mg (R160), or placebo (PBO). 16-week efficacy endpoints of GFs per pt and proportion of pts with ≥1 and ≥2 GFs were determined. Risk or rate ratios were estimated as treatment value divided by placebo value using generalized linear models and weighted for subgroup size; 1-risk ratio in percentage indicates relative risk reduction.
Results Baseline characteristics were similar across treatment groups. The population was mainly male (93%), white (67%), and mean age was 51.7±12.3 yrs. By week 16, the R80 (n=162) and R160 (n=165) pts experienced GF rate reductions of 72%>76% relative to PBO (1.15 GFs per pt) (n=161) (both P<.0001). Risk reductions for % of pts with ≥1 GFs were 57% (R80) and 64% (R160), and 79% and 85% for ≥2 GFs, respectively. Treatment effects were consistent with the individual studies. Significant reductions (P<.05) with R80 and R160 were observed for most endpoints when stratified by demographic and clinical characteristics, including race, age, disease duration, baseline uric acid level, presence vs. absence of visible tophi, and presence vs. absence of anti-drug (anti-rilonacept) antibodies during treatment; reductions were generally greater with R160. The most common category of adverse event (AE), infections, was balanced among treatments; the most frequent treatment-related AE, injection site reaction, was greatest with R160.
Conclusions Pooled efficacy and safety data are consistent with those from the individual trials in demonstrating efficacy and tolerability of rilonacept for GF prevention in pts initiating ULT. Reductions in GFs were broadly observed regardless of demographic or clinical characteristics.
Disclosure of Interest R. Evans Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., R. Terkeltaub Grant/Research support from: Regeneron Pharmaceuticals, Inc., Consultant for: Regeneron Pharmaceuticals, Inc., E. Mitha Grant/Research support from: Regeneron Pharmaceuticals, Inc., J. Wang Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., C. Barton Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., H. Schumacher Grant/Research support from: Regeneron Pharmaceuticals, Inc., Consultant for: Regeneron Pharmaceuticals, Inc.
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