Pegloticase

(Krystexxa®)

Krystexxa®

Drug updated on 10/17/2024

Dosage FormInjection (intravenous; 8 mg/mL)
Drug ClassPEGylated 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.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • 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 TitleYearSource
Krystexxa (pegloticase) Prescribing Information.2022Horizon Therapeutics USA, Inc., Deerfield, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The effect of immunomodulators on the efficacy and tolerability of pegloticase: a systematic review.2021Seminars in Arthritis and Rheumatism
Interventions for tophi in gout.2021Cochrane Database of Systematic Reviews

Clinical Practice Guidelines

Document TitleYearSource
2020 American College of Rheumatology guideline for the management of gout.2020American College of Rheumatology