Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response by monitoring serum uric acid during pegylated uricase therapy
597089 Disclosed is a method for diagnosing the risk of infusion reactions in a patient undergoing PEGylated uricase therapy, comprising the steps of: determining uric acid levels in a biological sample obtained from said patient at least 2 hours after administration of PEGylated uricase, wherein a uric acid level of more than 4mg/dl indicates that said patient is at risk of infusion reactions and PEGylated uricase therapy is to be discontinued. Further disclosed is a method to predict whether a patient will develop infusion reaction after undergoing PEGylated uricase therapy, said method comprising the steps of: determining uric acid levels in a biological sample obtained from said patient at least 2 hours after administration of PEGylated uricase, wherein maintenance of a uric acid level at less than 4mg/dl indicates said uric acid level is associated with a lower likelihood of infusion reaction or wherein a uric acid level of at least 4mg/dl in said determined uric acid level indicates a higher likelihood of infusion reaction at a time point, when the uric acid level is measured. Further disclosed is a method to predict whether a patient will develop antibody-mediated PEGylated uricase clearance after being treated with PEGylated uricase without measuring anti-PEGylated uricase and anti-PEG antibodies titer, comprising the steps of: determining uric acid levels in a biological sample obtained from said patient at least 2 hours after administration of PEGylated uricase, wherein maintenance of a level at less than 4mg/dl indicates that uric acid level is associated with a lower likelihood of antibody-mediated PEGylated uricase clearance or wherein a uric acid level of at least 4mg/dl indicates that said determined uric acid level is associated with a higher likelihood of antibody-mediated PEGylated uricase clearance at a time point when said uric acid level is measured.
