Pegloticase

(Krystexxa®)

Krystexxa®

Drug updated on 12/11/2024

Dosage FormInjection (intravenous; 8 mg/mL)
Drug ClassUric 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
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  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Pegloticase (biweekly) significantly increased tophi resolution in gout patients, with 21 out of 52 participants achieving resolution versus 2 out of 27 on placebo (relative risk (RR) 5.45, 95% confidence interval (CI) 1.38 to 21.54; number needed to treat (benefit) (NNTB) 3, 95% CI 2 to 6). Monthly dosing showed lower effectiveness (RR 2.86, 95% CI 0.68 to 11.97; NNTB 8, 95% CI 4 to 91).
  • Immunomodulation in refractory gout cases showed high response rates when combined with pegloticase: methotrexate (87.5%), mycophenolate mofetil (86.4%), azathioprine (63.6%), and leflunomide (66.7%), indicating a potential benefit for refractory cases.
  • Lesinurad (200 mg and 400 mg) combined with allopurinol did not significantly improve tophi resolution, while lesinurad (400 mg) with febuxostat may be marginally beneficial compared to the 200 mg dose with febuxostat (RR 1.11, 95% CI 0.85 to 1.46).
  • For pegloticase (biweekly), similar proportions of participants experienced adverse events compared to placebo (RR 0.99, 95% CI 0.91 to 1.07), though withdrawals due to adverse events were higher in the pegloticase group (15 out of 85) versus placebo (1 out of 43) (RR 7.59, 95% CI 1.04 to 55.55; number needed to harm (NNTH) 7, 95% CI 4 to 16).
  • For pegloticase (monthly), adverse event incidence was similar between pegloticase and placebo (RR 1.05, 95% CI 0.98 to 1.14), with increased withdrawals due to adverse events for pegloticase (16 out of 84) versus placebo (1 out of 43) (RR 8.19, 95% CI 1.12 to 59.71; NNTH 6, 95% CI 4 to 14).
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

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