Abstract: PUB318
Safety of Pegloticase with Immunomodulation Co-Therapy: Literature Review
Session Information
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Peterson, Jeff R., Western Washington Medical Group Arthritis Clinic, Bothell, Washington, United States
- Roe, Nathan, Horizon Therapeutics plc, Deerfield, Illinois, United States
- Kenney, Howard M., Arthritis Northwest, Spokane, Washington, United States
- Abdellatif, Abdul A., Baylor College of Medicine, Division of Nephrology, Houston, Texas, United States
- LaMoreaux, Brian, Horizon Therapeutics plc, Deerfield, Illinois, United States
Background
Gout occurs frequently among Chronic Kidney Disease (CKD) patients. Pegloticase therapy for uncontrolled gout does not require renal adjustments and is effective across all stages of CKD. Efficacy can be limited by development of anti-drug antibodies, which also increase the risk of infusion reactions (IR). A recent study reviewed publications on pegloticase with immunomodulating (IMM) co-therapy and demonstrated an increased response rate compared to the pivotal trials; however, aggregate safety data from the literature has not been reported.1 The purpose of this study is to report IR prevalence and adverse events (AEs) of interest in publications which have evaluated the co-prescription of IMM with pegloticase.
Methods
Studies of pegloticase (q2w) use with concurrent IMM were identified in a search of PubMed and abstracts from professional society meetings (2012-2020). AEs were extracted and reported including IRs, gout flares, and infections. Gout flares and infection occurrence were not described in all studies, therefore, only studies where occurrence was specifically addressed were included.
Results
10 publications were identified using IMM with pegloticase consisting of 82 total patients. Methotrexate was the most common IMM co-therapy. Due to the frequency of CKD in gout patients, 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. 3/82 (3.7%) patients experienced an IR during pegloticase treatment (total of 3/955 [0.3%] of infusions). Severity was described for 2 of the 3 IRs and were listed as mild. No instances of severe IR or anaphylaxis were reported. Gout flares as a % of patients were reported for 3 studies and occurred in 25/34 (72.2%). Among the 10 publications, 2 clinical studies reported details on infections. In these 2 studies (n=36), 5 infections occurred.
Conclusion
Pegloticase administered with IMM co-therapy had a low rate of mild IRs with no anaphylaxis reported. This study demonstrates 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.
References
1. Keenan RT, et al. Semin Arthritis Rheum. 2021 Apr;51(2):347-352.
Funding
- Commercial Support – Horizon Therapeutics plc