Pegloticase effectively treated gout in patients on dialysis, may lower ESA use
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A study of patients on hemodialysis found pegloticase was successful in treating gout, while also demonstrating the potential to lower erythropoiesis-stimulating agent dose requirements following the therapy.
According to Brad Marder, MD, medical director of Horizon Therapeutics, these results — which were presented virtually at the National Kidney Foundation Spring Clinical Meetings — are promising and provide “real-world evidence” pointing toward the effectiveness of the medication.
“The literature suggests a high prevalence of chronic kidney disease in patients with uncontrolled gout, but the pivotal trials for pegloticase did not formally study dialysis patients,” Marder, who told Healio Nephrology of the rationale behind the research, said. “While a phase 1 trial using pegloticase in patients on hemodialysis has demonstrated its efficacy despite the dialysis procedure, there is no literature regarding uncontrolled gout and the use of pegloticase in this patient group. As such, we sought to study real-world use via the [United States Renal Data System] USRDS database and provide a better understanding of potential treatment implications and options for those chronic kidney patients with uncontrolled gout undergoing dialysis.”
To this end, the researchers included 42 patients; the most common causes of end-stage kidney disease were diabetes, hypertension and glomerulonephritis. The mean interval between pegloticase doses was 14 days, with nine patients receiving at least 12 infusions of the drug.
Marder and colleagues observed that while hemoglobin levels were similar before and after pegloticase therapy (10.9 g/dL vs. 10.4 g/dL), patients who were also taking ESAs (both before and after pegloticase) had significantly lower dosing requirements after the therapy (specifically, the dosing requirement was lower by 14,574 units per month per patient).
“This finding means less medication may be required to manage the anemia that is common in patients with chronic kidney disease once gout has been effectively treated,” Marder said. “This finding is compelling because it implies that uncontrolled gout produces enough chronic and widespread inflammation to block red blood cell production. While this is an exploratory finding, we are excited about utilizing this hypothesis in further research because it reiterates that gout is not just an intermittent disease of the joints, but a progressive and systemic inflammatory condition with severe impacts throughout the body.”
As for next steps, Marder said it is important to remember that although some uric acid can be removed by dialysis, gout remains a challenge for a significant proportion of this patient population.
“We should feel compelled by these data to better understand pegloticase as a potential therapeutic option for dialysis patients failing to achieve control of their uric acid with other first-line agents,” he concluded.
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Bleyer AJ, et al. Abstract #183. Presented at: National Kidney Foundation Spring Clinical Meetings (virtual meting); April 6-10, 2021.
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