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Improvement in hepatic fibrosis estimated by Fibrosis-4 index in pegloticase treated chronic refractory gout patients
N. Schlesinger1, V.K. Rustgi2, A.E. Yeo3, P.E. Lipsky4
- Division of Rheumatology and Gout Center, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA. schlesna@rutgers.edu
- Hepatology, Center for Liver Diseases and Liver Masses, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
- Yeo Analytics, LLC, Jersey City, NJ, USA.
- AMPEL BioSolutions, LLC, Charlottesville, VA, USA.
CER15377
2023 Vol.41, N°1
PI 0060, PF 0066
Full Papers
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PMID: 35349415 [PubMed]
Received: 29/11/2021
Accepted : 21/02/2022
In Press: 23/03/2022
Published: 23/01/2023
Abstract
OBJECTIVES:
To determine whether lowering serum urate (SU) affects the course of non-alcoholic fatty liver disease (NAFLD).
METHODS:
Retrospective data analysis from chronic refractory gout patients who participated in two 6-month pegloticase randomised clinical trials compared patients who received pegloticase biweekly to those who received placebo. Patients with persistent urate-lowering to <1 mg/dL in response to biweekly pegloticase (responders, n=36) were compared to those who received placebo (n=43). NAFLD was assessed using the Fibrosis-4 (Fib-4) index. Comparisons between groups were carried out using 2 sample Wilcoxon tests or regression analysis.
RESULTS:
At baseline the mean (standard deviation [SD]) Fib-4 values were 1.40 (0.86) in pegloticase responders, and 1.04 (0.53) in patients receiving placebo. Patients receiving placebo exhibited a change of 0.26 (0.41) in Fib-4 score over 6 months vs 0.13 (0.62) for pegloticase responders (p=0.048). When only patients with a Fib-4 value >1.3 were considered (n=27), a significant difference in the change in the Fib-4 values between pegloticase responders vs. placebo was observed (-0.15 [0.67] vs. 0.7 [0.42], p=0.04). The correlation between the SU area under the curve (AUC) over the 6-month trial period and the change in Fib-4 value was R=0.33 (p=0.0004). Multivariable analysis indicated SU AUC was the only significant contributor to the change in Fib-4 values (p=0.018).
CONCLUSIONS:
Persistent lowering of SU significantly reduced Fib-4 scores, implying a possible effect on NAFLD progression. These results support the consideration of a complete analysis of the impact of profound urate-lowering on NAFLD as measured by the Fib-4 index.
