
To assess efficacy, safety, pharmacokinetics, and immunogenicity of pegloticase+methotrexate (MTX) vs. pegloticase+placebo (PBO) co‐treatment in a randomized, controlled, double‐blind trial. MTX co‐therapy markedly increased pegloticase response rate over PBO (71.0% vs. 38.5%) during Month‐6 with no new safety signals. These findings verify higher treatment response rate, lower IR incidence, and lower immunogenicity when pegloticase is co‐administered with MTX.
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