A Randomized, Double‐Blind, Placebo‐Controlled Multicenter Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving Pegloticase: 12‐Month Findings

Autor: John K. Botson, Kenneth Saag, Jeff Peterson, Katie Obermeyer, Yan Xin, Brian LaMoreaux, Lissa Padnick‐Silver, Supra Verma, Suneet Grewal, Amar Majjhoo, John R. P. Tesser, Michael E. Weinblatt
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: ACR Open Rheumatology, Vol 5, Iss 8, Pp 407-418 (2023)
Druh dokumentu: article
ISSN: 2578-5745
DOI: 10.1002/acr2.11578
Popis: Objective To assess 12‐month safety and efficacy of pegloticase + methotrexate (MTX) versus pegloticase + placebo (PBO) cotherapy in a PBO‐controlled, double‐blind trial (A randomized, double‐blind, placebo‐controlled, multicenter, efficacy and safety study of methotrexate to increase response rates in patients with uncontrolled gout receiving pegloticase [MIRROR RCT]). Methods Patients with uncontrolled gout (serum urate level [SU] ≥7 mg/dl, oral urate‐lowering therapy failure or intolerance, and presence of one or more gout symptoms [one or more tophi, two or more flares in 12 months, gouty arthropathy]) were randomized 2:1 to receive pegloticase (8‐mg infusion every 2 weeks) with blinded MTX (oral 15 mg/week) or PBO for 52 weeks. Efficacy end points included proportion of responders (SU level
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