Shorter Pegloticase Infusions Maintain Safety and Efficacy in Uncontrolled Gout
A phase 4 trial suggests that pegloticase can be safely administered over 60 minutes—half the traditional infusion time—when coadministered with methotrexate, potentially easing logistical barriers for patients with uncontrolled gout. The findings come from the open-label AGILE trial, which evaluated whether shorter infusion durations could preserve safety and efficacy while improving treatment feasibility.
Pegloticase is indicated for patients with refractory gout who have failed conventional urate-lowering therapy, but the standard 120-minute, biweekly infusion schedule can limit access and adherence. The AGILE study sequentially evaluated 60-, 45-, and 30-minute infusion durations, selecting the optimal time based on safety outcomes assessed over 24 weeks.
Following safety review, the 60-minute cohort (n=116) was selected for continued evaluation. Infusion reactions occurred in 6.0% of patients, including anaphylaxis in 1.7%. A sustained urate-lowering response—defined as serum urate levels below 6 mg/dL for at least 80% of weeks 20 to 24—was achieved in 67.2% of patients. Pegloticase was discontinued due to infusion reactions, anaphylaxis, or loss of urate-lowering response in 19.0% of participants.
The safety profile remained consistent with expectations. At least one adverse event was reported in 77.6% of patients, while serious adverse events occurred in 3.4%. Investigators concluded that “safety, tolerability, and efficacy results of pegloticase infused for 60 minutes were comparable to traditional infusion durations (120 min).”
The authors noted that shorter infusion times could help address real-world barriers associated with prolonged infusion visits, particularly in patients requiring long-term therapy for refractory disease.
By demonstrating that a reduced infusion duration remains effective and well tolerated, the AGILE trial supports greater flexibility in pegloticase administration and may expand access to treatment for patients with severe, uncontrolled gout.
Reference
Troum OM, Botson JK, Fang F, Mohammad AS, Verma S, LaMoreaux B. Safety, tolerability, and efficacy of shorter infusion durations of pegloticase administered to patients with uncontrolled gout receiving methotrexate: AGILE trial. J Clin Rheumatol. 2026;32(1):e16-e22. doi:10.1097/RHU.0000000000002283
