Characteristics and Management of Uncontrolled Gout Prior to Pegloticase Therapy: A 2-year Claims Analysis

Rheumatol Ther. 2024 Nov 14. doi: 10.1007/s40744-024-00723-9. Online ahead of print.

Abstract

Objective: Gout is a progressive form of arthritis that causes significant pain and disability. Patients with treatment-refractory (or uncontrolled) gout experience a higher prevalence and severity of comorbidities than those whose gout is controlled. Pegloticase is a recombinant PEGylated uricase indicated for the treatment of gout in patients refractory to conventional therapy. We evaluated the treatment journey of patients with chronic uncontrolled gout before initiation of pegloticase therapy.

Methods: Using IQVIA's PharMetrics® Plus database, we conducted a retrospective observational analysis of adults with ≥ 1 pegloticase claim between April 1, 2011, and August 31, 2020. Demographics were assessed at baseline. Clinical outcomes, health care resource utilization (HCRU), and associated costs were compared over two 12-month periods (months 13-24 and 1-12) prior to the first pegloticase claim (index date).

Results: The study included 408 patients. Prevalence of all gout-associated conditions increased between months 1-12 and 13-24 (P < 0.05 for all). The percentage of patients with tophi increased from 15.4% to 61.5%, the percentage with ≥ 1 flare increased from 49% to 84%, and mean number of flares per patient increased from 1.0 to 2.1 (P < 0.0001 for all). The frequency of all categories of HCRU except emergency department visits also increased (P < 0.0001 for all), as did gout-related healthcare utilization (P£0.005).

Conclusions: Patients with uncontrolled gout experienced an increase in the clinical burden of disease and HCRU in the 2 years before the initiation of pegloticase. Earlier patient identification and initiation of potentially effective therapy may help alleviate these burdens.

Keywords: Flare; Gout; Health services research; Pegloticase; Registry; Treatment-refractory; Uncontrolled; Uric acid.

Plain language summary

Gout is a progressive and painful form of arthritis. Patients with uncontrolled gout have a higher risk of other health problems, including high blood pressure, heart disease, and kidney disease, compared to those whose gout is well controlled. Pegloticase is a medication for patients whose gout has not responded to other treatments. In this study, we used health claims data to understand the treatment journey of 408 patients with gout who were treated with pegloticase. In the 2 years before starting pegloticase, patients experienced increasingly severe gout symptoms as well as an increase in other conditions such as high blood pressure and kidney disease. As a result, these patients required progressively more medication, including opioids, and health care resources. These findings confirm that gout is a progressive condition, and that earlier identification of patients whose gout is not controlled is important to relieving the burden of this disease.