Crealta announced results from two Phase 3 trials and one open-label extension trial on loss of urate-lowering response to Krystexxa (pegloticase) and risk of infusion reactions cited in the product’s Food and Drug Administration (FDA)-approved labeling. The findings were published in the Journal of Clinical Rheumatology.
In the analysis, data from two 6-month replicate Phase 3 randomized controlled trials (RCTs) and one open-label extension study was pooled and assessed for risk of infusion reactions. Infusion-related reactions were reported in 26% of patients receiving the FDA-approved dose (8mg/biweekly) and 5% in patients receiving placebo during the Phase 3 trials. Retrospective analyses showed that 91% of IRs occurred in patients receiving the FDA-approved dose who lost response to Krystexxa, as determined by a pre-infusion sUA level >6mg/dL. IRs occurred in fewer than one per 100 infusions in patients sustaining a sUA of <6mg/dL.
The authors emphasize the following recommendations for Krystexxa administration:
- Monitor serum uric acid (sUA) levels prior to each infusion.
- Discontinue therapy if sUA exceeds 6mg/dL, particularly when two consecutive measurements of sUA >6mg/dL occur.
- Premedicate patients with antihistamines and corticosteroids and monitor closely for signs and symptoms of IRs and anaphylaxis for an appropriate period of time.
Pegloticase is indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
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