SAT0591 REAL-WORLD PATTERNS OF PEGLOTICASE USE FOR TREATMENT OF GOUT IN THE U.S.

Abstract

Background:Pegloticase is used in severe refractory gout or in cases of intolerance to other urate lowering therapies but the real-world use of pegloticase since its U.S. Food and Drug Administration approval in 2010 is not known.Objectives:We sought to evaluate the real-world patterns of pegloticase use in the U.S. and the incidence of safety outcomes with its use.Methods:We conducted a retrospective descriptive study using data from two U.S. commercial insurance claims databases (MarketScan and Optum, 2010-2018). We identified new initiators of pegloticase with ≥1 gout diagnosis code in the 365-day baseline period prior to pegloticase initiation. We measured the number and duration of pegloticase therapy. We assessed the risk of anaphylaxis, cardiovascular events including myocardial infarction or stroke, hospitalization for heart failure (new onset or exacerbations) while receiving pegloticase therapy.Results:Among 2.9 million patients with ≥1 diagnosis code for gout, we identified only 483 (179 in Optum and 304 in MarketScan) pegloticase initiators. The mean age and % female was 55.6 years, 10.9% for MarketScan and 60.6 years and 17.3% for Optum (Table). Cardiovascular comorbidities were prevalent in both cohorts. Hypertension was present in up to 85%, diabetes mellitus in 38%, chronic kidney disease in 46%, and heart failure in 21% of the patients. As expected, use of gout-related medications at baseline was common. The median duration of pegloticase therapy was 93 days (interquartile range [IQR] 56-186) in MarketScan and 105 (IQR 56-127) in Optum. The median number of pegloticase infusions was 4 (IQR 2-10) for MarketScan and 5 (IQR 2-12) in Optum. In MarketScan, 57 (18.8%) patients switched to allopurinol, 64 (21.1%) to febuxostat, and 2 (0.7%) to probenecid during the mean 0.5-year followup time. Similarly, during the mean 0.5-year followup time in Optum, 38 (21.2%) patients switched to allopurinol, 34 (19.0%) to febuxostat, and 2 (1.1%) to probenecid. During the mean 0.5-year follow-up time on pegloticase, there were 3 (0.6%) anaphylaxis, 7 (1.4%) composite cardiovascular, 31 (6.4%) heart failure hospitalizations, and 3 (0.6%) deaths in both datasets.Conclusion:Pegloticase is rarely used in gout, and the median duration of pegloticase therapy was 3 months. There were few anaphylaxis events captured in this claims-b ased study, while heart failure hospitalizations were common.Table.Select baseline characteristics of pegloticase initiatorsMarketScanOptumN304179Mean age (SD), years55.62 (12.83)60.58 (12.85)Female sex, %10.917.3ComorbiditiesHypertension, %73.084.9Diabetes mellitus, %34.938.0Heart failure, %12.520.7Coronary artery disease, %12.826.3Chronic kidney disease, %34.245.8Malignancy, %10.28.4Medication useNSAID/COXIB use, %51.340.0Colchicine use, %72.065.4Allopurinol use, %33.647.5Febuxostat use, %38.836.9Probenecid use, %8.24.5Oral steroid use, %67.172.1Anakinra use, %5.96.7Disclosure of Interests:Sarah Chen Employee of: After finishing the work for this abstract, she has moved to work for Gilead., Jun Liu: None declared, Seoyoung Kim Grant/research support from: Research grants from Pfizer, AbbVie, Bristol-Myers Squibb and Roche for unrelated studies