Drug updated on 4/17/2024
Dosage Form | Injection (intravenous; 8 mg/mL) |
Drug Class | PEGylated uric acid specific enzymes |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of chronic gout in adult patients refractory to conventional therapy.
Summary
- Pegloticase (Kyrstexxa) is a recombinant PEGylated uricase that converts relatively insoluble urate to highly water-soluble allantoin, which is readily excreted by the kidneys.
- The drug has been indicated for refractory or uncontrolled gout and it's the first and only biologic treatment available for this condition.
- Clinical trials have shown a 6-month pegloticase responder rate of 42%, with non-responders largely developing high-titer anti-drug antibodies against pegloticase.
- A systematic review examined published cases of refractory gout patients treated with immunomodulation in combination with pegloticase.
- Ten publications describing 82 cases were identified where overall response rate was found to be at 82.9%. Patients co-treated with an individual immunomodulator had varying response rates: methotrexate -87.5%, mycophenolate mofetil -86.4%, azathioprine -63 .6%, leflunomide -66 .7%.
- The two patients who were treated using more than one immunomodulator both responded positively suggesting that combining therapies could potentially improve patient outcomes when treating uncontrolled gout using Kyrstexxa (pegloticase).
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Krystexxa (pegloticase) Prescribing Information. | 2022 | Horizon Therapeutics USA, Inc., Deerfield, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The effect of immunomodulators on the efficacy and tolerability of pegloticase: a systematic review. | 2021 | Seminars in Arthritis and Rheumatism |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2020 American College of Rheumatology guideline for the management of gout. | 2020 | American College of Rheumatology |