Medication Approved for Uncontrolled Gout
The FDA approved an expanded indication for pegloticase (Krystexxa) injection for intravenous use co-administered with methotrexate to help more people with uncontrolled gout achieve a complete response to therapy. Pegloticase is a product of Horizon Therapeutics.
The approval for the new indication was based on trial data that showed:
- A greater than 30 percentage-point increase in patient response rate during Month 6: 71% of patients randomized to receive pegloticase with methotrexate versus 39% of patients randomized to receive pegloticase with placebo achieved the primary end point (serum uric acid <6 mg/dL at least 80% of the time during Month 6);
- Improvement in the patient response rate remained nearly 30 percentage points higher during Month 12: 60% of patients randomized to receive pegloticase with methotrexate achieved a complete response during Month 12 compared with 31% of patients randomized to receive pegloticase with placebo;
- Significant reduction in infusion reactions from 31% to 4%. No new safety signals were observed.
The most commonly reported adverse reactions associated with pegloticase administered with methotrexate are gout flares, arthralgia, COVID-19, nausea, and fatigue. Pegloticase labeling contains a Boxed Warning about anaphylaxis and infusion reactions, G6PD deficiency associated hemolysis, and methemoglobinemia. For full prescribing information, consult product labeling.