Use of Pre-Infusion Serum Uric Acid Levels as a Biomarker for Infusion Reaction Risk in Patients on Pegloticase.

ABSTRACT:

Introduction

The aim of this work is to evaluate the impact of the timing of pre-infusion serum uric acid (sUA) test results for use in applying stopping rules for pegloticase to identify patients at risk for infusion reactions (IRs) while on therapy.

Methods

Data from the phase 3 clinical trials of pegloticase were reviewed and individual uric acid levels of the 85 patients who received the approved regimen of biweekly infusions were examined in relation to the occurrence of IRs.

Results

Of the 22 patients (26%) who experienced an IR on pegloticase therapy without uric acid stopping rules, only seven (8%) would have had IRs if pegloticase therapy had been discontinued after two consecutive pre-infusion sUA levels above 6 mg/dl. If pegloticase therapy was stopped afte

SUBMITTER: Keenan RT 

PROVIDER: S-EPMC6513953 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature