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Shortened Pegloticase Infusions Feasible for Uncontrolled Gout, Reduces Treatment Burden
Infusion reaction rates and serum level lowering were similar between 120-minute and 60-minute infusion cohorts in the phase 4 AGILE study.
Shortened, 1-hour infusion times of pegloticase (Krystexxa; Amgen) in combination with methotrexate were well-tolerated with preserved efficacy in patients with uncontrolled gout, demonstrating a promising option for reducing treatment burden.1
These findings, from the phase 4 AGILE study, were presented at the American College of Rheumatology (ACR) Convergence 2024, held November 14-19 in Washington, DC, by Brian LaMoreaux, MD, MS, Executive Medical Director, Amgen.
“Pegloticase is currently approved to be given over a 2-hour period and this often has an impact… on [patients’] daily lives, if this is an every 2 week therapy for at least 6 to 12 months,” primary investigator Orrin Troum, MD, clinical professor of medicine, Keck School of Medicine, University of Southern California, and director, clinical rheumatology research, Providence St John's Hospital, Santa Monica, California, told HCPLive during the meeting.
Data from AGILE were from 215 participants who underwent a 4-week oral MTX run-in followed by 24 weeks of pegloticase+MTX treatment, and then 60-, 45-, or 30-min biweekly infusions. The study primarily evaluated infusion reactions (IRs) between cohorts and the 60-minute cohort was chosen for moving forward, given the 30-minute cohort had the highest IR rate (12.9%; n = 8/62) compared to 0% in the 45-and 6-minute cohorts. AGILE enrolled additional patients in the 60-minute cohort for a modified intent-to-treat (mITT) population of 116 participants.1
The mITT population was made up of 90% men with a mean age of 55.2 years (standard deviation [SD], 11.3), BMI of 33.6 kg/m2 (SD, 6.3), eGFR of 76.5 ml/min/1.73m2 (SD, 19.4); and a gout history of 12.0 years (SD, 10.4). Most (66%) had tophi. They had an average of 7.0 flares (SD, 7.1) in the prior year and a mean serum urate (SU) of 8.7 mg/dL (SD, 1.7).1
Troum and colleagues found that the IR rate was 6.0% (95%CI, 2.5-12.0%; n = 7) in the mITT group, including anaphylaxis (AR) in 2 patients (1.7%). AGILE met its primary endpoint, with the upper 95% CI bound for IR rate being less than 13% (as per a prespecified threshold)1 and similar to the 4.2% (including AR in 1.0%) in a prior pegloticase+MTX registrational trial with 120-min infusions (MIRROR RCT).2 The SU-response rate (SU < 6 mg/dL for ≥80% of Weeks 20-24 during Month 6) secondary endpoint was also met, with a 67.2% rate (95%CI, 57.9-75.7%) compared with 74.0%.1
“[It’s important that] patients that have gout, that have uncontrolled gout get to the rheumatologist that has familiarity with using pegloticase. Krystexxa has been available for many years now, with the co-administration of methotrexate doubling the efficacy and reducing the infusion reactions, it’s impressive. But the patients need to get to the appropriate physicians,” Troum said.
