From the Guidelines
Pegloticase is a medication used to treat severe gout in adults who have not responded to other treatments, specifically those with frequent gout flares or nonresolving subcutaneous tophi. It is an enzyme that breaks down uric acid in the body. The recommended dose is 8 milligrams administered intravenously every 2 weeks 1.
Key Points
- Treatment duration is typically 6 months, but may be extended based on patient response and tolerance 1.
- Patients should be monitored for infusion reactions and serum uric acid levels during treatment.
- Contraindications include glucose-6-phosphate dehydrogenase (G6PD) deficiency, due to the risk of hemolysis.
- Pegloticase is strongly recommended for patients with gout for whom XOI treatment, uricosurics, and other interventions have failed to achieve the SU target, and who continue to have frequent gout flares (≥2 flares/year) or who have nonresolving subcutaneous tophi 1.
Important Considerations
- The medication is not recommended as first-line treatment for gout, but rather for patients who have failed other treatments 1.
- Patients with infrequent gout flares and no tophi are not recommended to receive pegloticase due to the potential for serious allergic reactions and high costs 1.
From the FDA Drug Label
KRYSTEXXA® (pegloticase) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy The use of pegloticase (uricase) is for the treatment of chronic gout in adult patients who are refractory to conventional therapy 2.
- It is specifically indicated for patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors.
- Important Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia.
From the Research
Use of Pegloticase (Uricase)
Pegloticase, a recombinant polyethylene glycol-conjugated form of uricase, is used to treat chronic gout refractory to conventional therapy 3, 4. The primary function of pegloticase is to catalyze the oxidation of uric acid to allantoin, thereby reducing plasma uric acid levels.
Mechanism of Action
- Pegloticase works by breaking down uric acid into allantoin, which is more soluble and easily excreted by the kidneys 3, 5.
- This mechanism helps to reduce the formation of urate crystals, which are responsible for the symptoms of gout.
Efficacy
- Studies have shown that pegloticase is effective in reducing plasma uric acid levels and improving symptoms of gout, including tophi resolution, frequency of gout flares, and tender joint count 3, 4.
- Pegloticase has also been shown to improve health-related quality-of-life parameters, such as disability, pain, and physical function 3.
Administration and Dosage
- Pegloticase is administered intravenously, typically every 2 or 4 weeks 3, 4.
- The recommended dose of pegloticase is 8 mg every 2 or 4 weeks 3, 4.
Safety and Adverse Events
- Common adverse events associated with pegloticase include gout flares, infusion reactions, and anaphylaxis 3, 4.
- Exacerbation of pre-existing congestive heart failure has also been reported in some patients receiving pegloticase 3.
Pre-Infusion Prophylaxis
- Corticosteroids, such as methylprednisolone or hydrocortisone, are often used as pre-infusion medications to prevent infusion reactions 6.
- Studies have shown that methylprednisolone may be more effective than hydrocortisone in reducing the risk of infusion reactions and allowing for longer duration of pegloticase therapy 6.