pegloticase (Krystexxa)
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Indications
Contraindications
- congestive heart failure (no data)
- concurrent administration of xanthine oxidase inhibitor
* concurrent use of xanthine oxidase inhibitor may mask a rising serum urate level associated with pegloticase antibodies[4]
Dosage
- 4-12 mg IV administration once every 2-4 weeks
- 8 mg IV every 2 weeks most effective dose
- pretreatment with glucocorticoid & antihistamine
- methotrexate coadministration can reduce risk for development of antibodies against pegloticase[4][6]
- treatment for 6 months[3]
Monitor
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
- most likely cause of treatment failure
- may exacerbate heart failure
- not associated with cardiovascular toxicity
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]
More general terms
References
- ↑ FDA NEWS RELEASE - Sept. 14, 2010 FDA approves new drug for gout http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225810.htm
- ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/18759308
- ↑ 3.0 3.1 3.2 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21846852 <Internet> http://jama.ama-assn.org/content/306/7/711.full
- ↑ 4.0 4.1 4.2 4.3 4.4 Medical Knowledge Self Assessment Program (MKSAP) 17, 18 American College of Physicians, Philadelphia 2015, 2018.
Medical Knowledge Self Assessment Program (MKSAP) 20 American College of Physicians, Philadelphia 2025 - ↑ 5.0 5.1 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. - ↑ 6.0 6.1 Botson JK, Saag K, Peterson J, et al. A randomized, placebo-controlled study of methotrexate to increase response rates in patients with uncontrolled gout receiving pegloticase: primary efficacy and safety findings. Arthritis Rheumatol. 2023;75:293-304. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36099211