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pegloticase (Krystexxa)

Indications: - refractory gout Contraindications: - congestive heart failure (no data) - concurrent administration of xanthine oxidase inhibitor - allopurinol - febuxostat [4]* , * concurrent use of xanthine oxidase inhibitor may mask a rising serum urate level associated with pegloticase antibodies [4] Pregnancy category: C [4] safe for dialysis patients [5] Dosage: - 4-12 mg IV administration once every 2-4 weeks - 8 mg IV every 2 weeks most effective dose - pretreatment with glucocorticoid & antihistamine - treatment for 6 months [3] Monitor: - serum uric acid Adverse effects: - severe allergic reaction in 1/3 of patients - anti-pegloticase antibody present in about 75% of patients - associated with diminished 1/2 life of pegloticase in some patients Mechanism of action: - polyethylene glycol-conjugated uricase - metabolizes uric acid into allantoin that is then excreted into the urine - diminishes uric acid levels - diminishes risk of uric acid crystalization in soft tissue & joints Clinical trials: - effective response (defined by serum uric acid < 6 mg/dL) ~ 40% [3]

General

hydrolase hypouricemic agent

References

  1. FDA NEWS RELEASE - Sept. 14, 2010 FDA approves new drug for gout http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225810.htm
  2. Sundy JS et al. Reduction of plasma urate levels following treatment with multiple doses of pegloticase (polyethylene glycol-conjugated uricase) in patients with treatment-failure gout: Results of a phase II randomized study. Arthritis Rheum 2008 Sep; 58:2882. PMID: 18759308
  3. Sundy JS et al Efficacy and Tolerability of Pegloticase for the Treatment of Chronic Gout in Patients Refractory to Conventional Treatment: Two Randomized Controlled Trials JAMA. 2011;306(7):711-720 PMID: 21846852 http://jama.ama-assn.org/content/306/7/711.full
  4. Medical Knowledge Self Assessment Program (MKSAP) 17, 18 American College of Physicians, Philadelphia 2015, 2018.
  5. Monaco K Pegloticase Safe for Dialysis Patients With Gout. Significant drop in monthly ESA dose seen after treatment, too. MedPage Today April 9, 2021. https://www.medpagetoday.com/meetingcoverage/nkf/92017 - Bleyer A, et al Pegloticase therapy in gout patients undergoing dialysis: a USRDS database study. National Kidney Foundation (NKF) 2021; Abstract 183.