Pos0938 Canakinumab With or Without Corticosteroids Reduced Gout Flares Associated With Pegloticase Treatment Regardless of the Immunomodulator Used: A Real-World Database Study

Background: The initiation of uric acid lowering treatment is associated with gout flares, likely as a result of remodeling of crystal deposits during dissolution.1 The greater the reduction in serum uric acid, the more likely a flare will occur. The American College of Rheumatology guidelines recommend colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs), or prednisone for prophylaxis. Pegloticase can dramatically reduce serum uric acid levels; however, despite prophylaxis with colchicine, NSAIDs, and methylprednisolone (MP) gout flares still frequently occur. In MIRROR RCT, 54% of patients in the pegloticase + methotrexate treatment group experienced a gout flare the first month and 67% of patients had at least one flare over the 52-week study.2 Canakinumab is FDA approved for treatment of recurrent gout flares in patients who cannot be treated with NSAIDs, colchicine, or repeated courses of corticosteroids3 but to our knowledge has not been studied in conjunction with pegloticase treatment. Objectives: To evaluate the effectiveness of canakinumab when treating gout flares associated with pegloticase + various immunomodulator medications (IMM) in a real-world setting. Methods: Using 2 private rheumatology clinics, a large de-identified database was assembled. Using the pegloticase drug code (J2507), all patients that received ≥1 pegloticase infusion from January 1, 2021 thru December 9, 2023 were identified. Each of these patients was then analyzed for the use of ≥1 canakinumab 150mg injection which created the study population. Demographics (age, gender, race), date(s) of canakinumab and pegloticase administration, IMM used, labs (serum uric acid, estimated glomerular filtration rate (eGFR), liver function tests), gout flares, and pegloticase treatment response were gathered. Number of gout flares, type of IMM, and use of preinfusion MP were highlighted. Results: A total of 358,328 patients were screened from the database. At least 1 dose of pegloticase was administered to 50 patients, 26 of which also received at least 1 canakinumab injection, which became the study population. Patient ages ranged from 34-89 with an eGFR range of 33-112 mL/min/1.73m2. Two patients were on hemodialysis. Additional patient data are displayed (Table 1). All 26 patients took an IMM with pegloticase (18 methotrexate (MTX), 6 mycophenolate (MMF), 1 azathioprine (AZA), and 1 rituximab (RIX)). There was 1 reported gout flare with MTX (and preinfusion MP) (Figure 1) which resolved with a single colchicine and indomethacin dose. In 3 patients, canakinumab was started after multiple pegloticase infusions were given. Preinfusion MP was used in 3 patients, with one patient stopping the MP after the second infusion without flare. Mild, transient elevations in liver functions were seen in 3 patients and 1 patient experienced 2 infections. Pegloticase response rate was 73% (19/26) with 7 patients having side effects or increased uric acid. A 1-hour infusion rate was used in 4 patients. Table 1. Key demographic and treatment information in patients administered canakinumab for gout flares related to pegloticase+IMM treatment. Conclusion: Canakinumab is effective in reducing gout flares associated with pegloticase treatment with and without corticosteroids. The specific IMM used in combination (MTX, MMF, AZA, RIX) had no effect on the efficacy of the canakinumab treatment. These findings support the use of canakinumab without corticosteroids in all patients undergoing treatment for gout with pegloticase regardless of the IMM used. REFERENCES: 1 Xin F et al. Int J Cllin Exp Med 2015; 8(11): 21460–21465. 2 Botson JK et al. Arthritis Rheumatol 2023;75:293-304. 3 Canakinumab PI 2023. Acknowledgements: NIL. Disclosure of Interests: Darion Heald: None declared, John Botson Speaker bureau: Abbvie, Amgen, and Horizon Therapeutics (now Amgen, Inc.)., Consultant: Horizon Therapeutics (now Amgen, Inc.) and Novartis., Grant/research support: Study site and principal investigator: Horizon Therapeutics (now Amgen, Inc.) and Olatec., Jeff Peterson Speaker bureau: Eli Lilly, Horizon Therapeutics (now Amgen, Inc.), and Janssen., Consultant: GlaxoSmithKline, Horizon Therapeutics (now Amgen, Inc.), Novartis, and Union Chimique Belge., Grant/research support: Study site and principal investigator Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Horizon Therapeutics (now Amgen, Inc.), Olatec, and SetPoint Medical.