Gout Remission With Pegloticase-Induced Intensive Urate-Lowering Therapy: A Post Hoc Clinical Trial Analysis.

Abstract

Objective: Gout is a type of painful inflammatory arthritis that affects patient health and quality of life, making remission a crucial goal. The Gout Hyperuricemia and Crystal-Associated Disease Network (G-CAN) recently proposed a standard definition for gout remission. Using adapted criteria from de Lautour et al and recent G-CAN criteria, this post hoc analysis used existing data from the Methotrexate to Increase Response Rates in Patients With Uncontrolled Gout Receiving Pegloticase (MIRROR) randomized controlled trial (NCT03994731) to determine potential gout remission rates in patients with pegloticase-induced intensive urate-lowering.

Methods: Based on the adapted gout remission criteria from de Lautour et al, remission was defined as meeting all of the following six criteria: resolution of ≥1 tophus, serum urate (SU) level <6 mg/dL, no gout flares in the previous three months, pain score ≤1 (10-point scale), swollen joint count ≤1, and Physician Global Assessment of Gout score ≤1. An abbreviated three-criteria definition, modeled after the G-CAN definition, included gout flare, SU level, and tophus resolution.

Results: A total of 145 patients received ≥1 dose of pegloticase (pegloticase with methotrexate, n = 96; pegloticase with placebo, n = 49), with 90 and 74 patients remaining on treatment through weeks 24 and 52, respectively. At weeks 24 and 52, 13.3% of patients (12 of 90) and 43.2% of patients (32 of 74) achieved gout remission using the six-criteria definition, and 36.7% (33 of 90) and 70.3% of patients (52 of 74) achieved remission using the three-criteria definition.

Conclusion: Using the study full and simplified definitions, nearly half to three-quarters of patients who remained on pegloticase for 52 weeks achieved gout remission. This novel analysis provides evidence that remission is possible in many patients with uncontrolled gout within one year of intensive, sustained urate-lowering.