Drug updated on 10/17/2024
Dosage Form | Injection (intravenous; 8 mg/mL) |
Drug Class | PEGylated uric acid specific enzymes |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
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Summary
- Kyrstexxa (pegloticase) is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Pegloticase Response Rate in Combination with Immunomodulation: The overall response rate to Pegloticase in combination with immunomodulators was 82.9%, with response rates varying depending on the specific immunomodulator used (e.g., Methotrexate: 87.5%, Mycophenolate mofetil: 86.4%, Azathioprine: 63.6%).
- Pegloticase for Tophi in Gout: Biweekly Pegloticase 8 mg infusions resulted in a 40.4% resolution of tophi (21/52 participants) compared to 7.4% with placebo (2/27 participants), with a Risk Ratio (RR) of 5.45 (95% CI 1.38 to 21.54) and a Number Needed to Treat (NNT) of 3 (95% CI 2 to 6).
- Withdrawals due to adverse events were higher in the Pegloticase groups compared to placebo, with biweekly Pegloticase showing 17.6% (15/85 participants) vs. 2.3% (1/43 participants) in placebo (RR 7.59, 95% CI 1.04 to 55.55; NNTH 7, 95% CI 4 to 17) and monthly Pegloticase showing 19% (16/84 participants) vs. 2.3% (1/43 participants) in placebo (RR 8.19, 95% CI 1.12 to 59.71; NNTH 6, 95% CI 4 to 14).
- The Population Types and Subgroup Considerations section identifies patients with refractory or uncontrolled gout and patients with tophi in gout as specific populations. Higher response rates were observed with Pegloticase in combination with specific immunomodulators, and Pegloticase was particularly effective in reducing tophi in patients with gout.
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 |
Interventions for tophi in gout. | 2021 | Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2020 American College of Rheumatology guideline for the management of gout. | 2020 | American College of Rheumatology |