Real-world use of immunomodulators in patients receiving pegloticase for chronic gout

Authors: Christine Miller, PharmD; Drew Doyle, RPh; Barbara Prosser, RPh – Soleo Health


Pegloticase is an intravenous therapy for chronic gout in adult patients refractory to conventional therapy. The prescribing information for pegloticase was updated in July 2022 to include the use of methotrexate, as this combination has been proven to increase efficacy and decrease the risk of infusion reactions.


The objective of this study is to identify trends in the real-world use of methotrexate in conjunction with pegloticase.


A modification to this organization’s clinical assessment for pegloticase was made in July 2022 to reflect the updated product labeling. A retrospective analysis of patient records from 07/08/2022-03/31/2023 was conducted via the proprietary clinical outcomes program SoleMetrics®. Responses within the clinical assessment were compared to information within each patient’s referral documentation and medication profiles.


Thirty-four patients received pegloticase within the study time period. The initial analysis focused on the response within the clinical assessment and found that 14 of the 34 patients received methotrexate (41%). A post hoc analysis of each patient’s medication profile and referral documentation was performed. The combined results of the initial and post-hoc analysis revealed that 26 of the 34 patients (76%) received an immunomodulator.

Figure 1. Post hoc analysis of immunomodulator use

Figure 2. Clinical interventions performed


A therapy-specific assessment for pegloticase identifies trends in immunomodulator prescribing habits. Although the prescribing information for pegloticase specifies the use of methotrexate, this study found that prescribers order mycophenolate at almost the same rate as methotrexate. Clinicians within this complex specialty pharmacy have the opportunity to intervene when an immunomodulator is not ordered in combination with pegloticase as a result of the assessment change, contributing to improved durability of response along with efficacy and tolerance. The results of this study also present the opportunity to modify the existing assessment to capture use of all immunomodulators, further analyze the occurrence of adverse events with or without the use of immunomodulators, and continue gathering pertinent real-world data around the treatment of chronic gout.

Authors of this presentation disclose the following concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation: Nothing to disclose

Originally presented at NASP 2023 Annual Meeting and Expo

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