Pegloticase

(Kyrstexxa®)

Kyrstexxa®

Drug updated on 5/17/2024

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.

Summary
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  • Pegloticase (Kyrstexxa) is recommended for the management of chronic gout in adult patients who have not responded to conventional treatment. Clinical trials indicate a 6-month responder rate of 42% when administered as a sole therapy, which markedly rises to an overall response rate of 82.9% when combined with various immunomodulatory drugs.
  • Two systematic reviews/meta-analyses provided insights into pegloticase's safety and effectiveness in comparison to other treatments for chronic gout that is resistant to conventional therapy.
  • The studies reveal that although there is no direct comparative data with other urate-lowering therapies such as allopurinol, febuxostat, or probenecid, pegloticase's distinct mechanism of action distinguishes it, particularly in refractory cases and especially when used in conjunction with immunosuppressants.
  • Regarding safety considerations, both biweekly and monthly dosing schedules reported high rates of adverse events including infusion reactions, which led to higher withdrawal rates; however, it was observed that about 80% of these were due to flares of the disease itself rather than the treatment.
  • Regarding population types and subgroup considerations: Individuals who have shown little or no response (refractory) to traditional urate-lowering therapies are identified as those who would benefit most from this medication. Moreover, those suffering from severe manifestations such as tophi also demonstrate significant improvement with the biweekly administration schedule.
  • Despite its increased risk profile related to adverse events, specifically infusion reactions, necessitating careful selection and monitoring of patients - additional research focused on different subgroups and long-term outcomes could enhance its utility in management strategies for chronic 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