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Comparison of Two Corticosteroid Pre-Infusion Regimens for Pegloticase in the United States: A Retrospective Analysis in Community Rheumatology Practices

BACKGROUND: Pegloticase is a recombinant porcine-like uricase enzyme that is FDA-approved for the treatment of chronic refractory gout in adults. Some patients receiving pegloticase develop anti-drug antibodies, which leads to both loss of pegloticase efficacy and an increased risk for infusion reac...

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Detalles Bibliográficos
Autores principales: Majjhoo, Amar, Kumar, Ada, Zdanis, Michael, LaMoreaux, Brian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6879681/
https://www.ncbi.nlm.nih.gov/pubmed/31673974
http://dx.doi.org/10.1007/s40801-019-00164-9
Descripción
Sumario:BACKGROUND: Pegloticase is a recombinant porcine-like uricase enzyme that is FDA-approved for the treatment of chronic refractory gout in adults. Some patients receiving pegloticase develop anti-drug antibodies, which leads to both loss of pegloticase efficacy and an increased risk for infusion reactions. In the pivotal trials, all patients received pre-infusion medications before each pegloticase dose, including intravenous (IV) hydrocortisone. In clinical practice, many clinicians use methylprednisolone for pre-infusion therapy with pegloticase; however, the efficacy of methylprednisolone compared with hydrocortisone as a pre-infusion medication for pegloticase has not been established. OBJECTIVE: The aim of this study was to compare the efficacy of methylprednisolone versus hydrocortisone as a pre-infusion medication for pegloticase. METHODS: Data were retrospectively collected from 92 qualifying patients treated with pegloticase and administered pre-infusion prophylaxis with either intravenous hydrocortisone or methylprednisolone. Patient demographics, steroid type and dose, duration of pegloticase therapy, overall number of infusions, and number of infusion reactions were assessed. RESULTS: Patients treated with methylprednisolone as a pre-infusion medication received on average 8.5 pegloticase infusions versus 4.9 infusions for patients who were treated with hydrocortisone (p < 0.001). In addition, a significantly lower proportion of patients receiving methylprednisolone had their course of therapy terminated early due to infusion reactions (8.2%) versus patients receiving hydrocortisone (41.9%, p < 0.01). CONCLUSION: In this retrospective chart-review project, patients were able to have a longer duration of pegloticase therapy, received a significantly greater number of infusions, and experienced fewer infusion reactions when methylprednisolone was used as the corticosteroid for pre-infusion prophylaxis compared with hydrocortisone. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s40801-019-00164-9) contains supplementary material, which is available to authorized users.