Prior research has shown that pegloticase therapy for uncontrolled gout does not require renal adjustments and is effective across all stages of CKD. Pegloticase with immunomodulating (IMM) co-therapy demonstrated an increased response rate compared with pivotal trials; however, aggregate safety data from the literature has not been reported. Therefore, researchers examined infusion reaction (IR) prevalence and adverse events (AEs) in the co-prescription of IMM with pegloticase. Studies of pegloticase (q2w) use with concurrent IMM were identified in a literature search and abstracts from professional society meetings (2012-2020). AEs were extracted and reported, including IRs, gout flares, and infections. Ten publications were identified using IMM with pegloticase; methotrexate was the most common IMM co-therapy. Due to the frequency of CKD in patients with gout, other IMM agents were frequently used, including mycophenolate mofetil, leflunomide, azathioprine, and cyclosporine. All reports included serum urate monitoring to evaluate the ongoing efficacy of pegloticase. Only 3.7% of patients experienced an IR during pegloticase treatment (0.3% of infusions). Severity was described for two of the three IRs and was listed as mild. No instances of severe IR or anaphylaxis were reported. Gout flares were reported in three studies and occurred in 72.2% of patients. The study team concluded that in addition to established improvements in pegloticase efficacy, the use of IMM co-therapy with pegloticase results in a favorable response rate and safety profile with low rate and severity of IRs.
