Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 8 mg/mL) |
Drug Class | 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
- 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 Title | Year | Source |
---|---|---|
Krystexxa (pegloticase) Prescribing Information. | 2022 | Horizon Therapeutics USA, Inc., Deerfield, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
What are the core recommendations for gout management in first line and specialist care? Systematic review of clinical practice guidelines | 2023 | Bmc Rheumatology |
Interventions for tophi in gout | 2021 | The Cochrane Database Of Systematic Reviews |
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 |