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The following is a summary of “Treatment-Emergent Major Adverse Cardiovascular and Thromboembolic Events were Infrequent During Clinical Trials of Pegloticase,” published in the January 2025 issue of Rheumatology by Troum et al.
Maintaining serum urate (SU) levels below 6 mg/dl reduces gout flares, but starting urate-lowering therapy (ULT) can trigger them. Gout flares may increase the risk of thromboembolic (TE) and cardiovascular (CV) events.
Researchers conducted a retrospective study on CV/TE event incidence after pegloticase initiation.
They analyzed pooled data from 4 trials, including 2 phase 3 trials (NCT00325195), an open-label trial (NCT03635957), and a randomized controlled trial (NCT03994731). Pegloticase (8 mg) was given every 2 or 4 weeks for 24 weeks, with some patients receiving methotrexate (15 mg/week). The high-risk window for CV/TE events was set at 120 days post-flare.
The results showed 5/328 (1.5%) patients had ≥1 CV/TE event during pegloticase treatment, including 3/244 (1.2%) on biweekly dosing (35.4 events/1000 person-years). All events occurred within the 120-day flare window.
Investigators found that CV/TE event incidence during pegloticase treatment was similar to the general gout population, indicating no increased risk.
Source: academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keaf017/7951311
