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Pegloticase effective for rapid resolution of tophi in gout
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Pegloticase quickly resolved tophi among patients with gout who responded to the treatment, according to data published in Arthritis Research & Therapy.
“Pegloticase is a recombinant mammalian uricase conjugated to polyethylene glycol approved in the United States for treatment of patients with chronic refractory gout,” Brian F. Mandell, MD, PhD, of the Cleveland Clinic, and colleagues wrote. “It profoundly decreases serum urate in biochemical responders to <1mg/dl. The results of the pegloticase randomized clinical trials provided the opportunity to determine the impact of persistent and markedly low levels of serum urate on the velocity of tophus resolution.”
To analyze the velocity with which tophi were resolved among those treated with pegloticase (Krystexxa, Horizon Pharma), Mandell and colleagues evaluated data from two identical randomized controlled studies of patients with refractory gout. Participants included a total of 66 patients treated with pegloticase and 21 who received placebo. All participants were adults with baseline serum urate level of 0.476 mmol/L or greater, and either at least three self-reported gout flares during the previous 18months, at least one tophus or gouty arthropathy, or a contraindication or nonresponse to treatment with allopurinol.
Participants’ tophi were assessed using computer-assisted measurements of standardized digital photographs. The researchers designated participants as “responders” or “nonresponders” based on the maintenance of a serum urate of less than 6mg/dL at months 3 and 6 of treatment. Researchers used linear regression analysis to determine the time of complete resolution of all tophi.
According to the researchers, of the 66 patients treated with pegloticase every 2 weeks, 23 were designated as responders, and 43 were nonresponders. Complete resolution of at least one tophus at 6months was achieved by 69.6% of responders, 27.9% of nonresponders and 14.3% of those who received placebo. In addition, 34.8% of biochemical responders, 11.6% of nonresponders and 0% of placebo-treated patients achieved complete resolution of all photographed tophi.
The mean velocity of resolution of all tophi was 60.1 mm2 per month among responders, with a mean projected time of complete resolution of 9.9months. In addition, there was a significant inverse correlation between serum urate area under the curve and tophus resolution velocity (r=–0.4; P=.0002). However, the researchers noted considerable heterogeneity in the velocity of resolution. Baseline tophus area was the only patient characteristic that correlated with velocity of tophus resolution.
“Pegloticase treatment causes a rapid resolution of tophi in responders, as predicted from the profound and persistent serum urate lowering associated with this therapy,” Mandell and colleagues wrote. “Even transient reductions in serum urate observed in nonresponders may result in complete resolution of tophi in some patients over the course of 6 months or less.” – by Jason Laday
Disclosure: Mandell reports being a clinical investigator for, and receiving consulting fees from, Horizon Pharma. Please see the study for all other authors’ relevant financial disclosures.
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