Gout Remission Achieved in Approximately Half of Patients Treated with Pegloticase

In a post hoc analysis of the MIRROR randomized controlled trial, 47% of patients with gout treated with pegloticase over 52 weeks were able to achieve remission. These data revealed patients may benefit from being treated with the drug longer than 6 months.¹

“The harmful effects of gout are apparent with growing evidence supporting detrimental musculoskeletal and systemic health consequences of this condition, particularly of acute gout flares,” wrote a team of investigators led by Yael Klionsky, MD, clinical assistant professor, Rheumatology and Immunology, at Wake Forest University School of Medicine.¹ “Akin to treatment goals of other rheumatic diseases, the concept of treating gout to remission is important for improving patient care and better understanding its impact on patient quality of life (QoL).”

Remission was previously defined as the absence of tophi, absence of acute flare, a serum urate level (SU) of < 6 mg/dL, minimal disease-related pain, and minimal gout-related QoL impact over 12 months. The impact of QoL is measured by the patient global assessment (PGA) of gout (with minimal categorized as < 2 on a 10-point scale) and minimal gout-related pain is defined as < 2 on a 10- point scale.¹

Gout remission rates among patients receiving 52 weeks of pegloticase treatment, comprised of an 8 mg infusion every 2 weeks, were evaluated using data from the MIRROR trial. In this analysis, remission was defined as SU < 6 mg/dL, the absence of flare during a specific treatment month, PGA ≤1, Health Assessment Questionnaire Pain (HAQ-Pain) ≤10, swollen joint count (SJC) ≤1, and resolution of ≥1 tophus (for those with tophi prior to treatment initiation.¹

Patients receiving concomitant methotrexate were included in the remission analysis as methotrexate itself does not impact remission criteria, although it does increase the SU-lowering response rate of pegloticase and lowers overall reaction risk. Patients who achieved 2 consecutive SU > 6 mg/dL after week 2 subsequently discontinued treatment and were excluded from the analysis.¹

Among the 145 patients who were treated with ≥ 1 pegloticase infusion, most (90%, n = 130) were male, the mean age was 54.8 years, and the median time since gout diagnosis was 14 years. At baseline, the mean PGA was 4.9±2.4, the HAQ-Pain was 40.3±29.4, the HAQ-Health was 42.2±28.3, and most (76%, n = 110) had tophi prior to initiating pegloticase treatment.¹

Approximately 62% (n = 90) of patients remained on treatment through week 24, of which 70 received concomitant methotrexate and 20 received placebo. A total of 74 patients were treated with pegloticase through week 52, with 58 patients in the methotrexate co-therapy group and 16 in the placebo group.¹

Results, which were presented at the 2024 European Congress of Rheumatology (EULAR), showed at week 24, 20% (n = 18/90) were able to achieve gout remission, which increased to 47% (n = 35/74) at week 52. The rates of patients able to meet each remission criterion continued to increase from week 24 through week 52, particularly for tophus resolution (34% to 68%), HAQ-Pain (48% to 73%), PGA (52% to 74%), and flare as observed in month 6 (82%) and month 12 (97%). The resolution of ≥ 1 tophus was met by the fewest number of patients at both time periods.¹

“These data demonstrate that successful intensive SU-lowering with pegloticase and subsequent urate depletion result in marked improvements in both gout signs/symptoms and patient QoL,” concluded investigators.¹

References

1. ^{Klionsky Y, Torralba K, Obermeyer K, Padnick-Silver L, et al. Achievement of “Gout Remission” During Intensive Urate-Lowering Over 52 Weeks of Pegloticase Therapy. Presented at: EULAR. Vienna, Austria. June 12 – 15, 2024.}