Background/Purpose: Pegloticase, a recombinant, PEGylated uricase enzyme, is used to treat uncontrolled gout in patients who do not improve on or are intolerant of oral urate-lowering therapies. As with other biologics, anti-drug antibodies (ADAs) against pegloticase can develop and cause infusion reactions and loss of treatment efficacy.¹ As a result of ADA formation, the pegloticase response rate in clinical trials was 42%.² DMARDs (e.g., azathioprine, methotrexate) are frequently used when treating autoimmune diseases with biologics to attenuate ADA development, often resulting in a more successful response to biologic therapy, and lower adverse event rates.³ Starting with a case-series presentation in late 2018, growing evidence in the literature supports using pegloticase with immunomodulation co-therapy, consistently showing a marked increase in treatment responder rates.^4-8 However, little is known about whether this practice is being implemented in clinical practice and, if so, how treatment patterns have changed over time. This study examined a large medical claims database to better understand immunomodulator use with pegloticase in the United States.

Methods: The IQVIA database contains 1.3 billion claims (made from November 2014 thru December 2019) of 30 million patients diagnosed with gout or chronic kidney disease. Patients who had received pegloticase were identified and classified based on immunomodulator use. Patients who were prescribed methotrexate or azathioprine within 60 days (before or after) of receiving the first pegloticase infusion were considered to have received co-administration of pegloticase/immunomodulator.

Results: Pegloticase/immunomodulation co-therapy rates were consistently low (1.2%-3.9%) from 2015 through 2018 (Figure 1). However, this rate markedly increased to 15.0% in 2019. The majority of patients (86%) who started an immunomodulator did so within 30 days of their first pegloticase infusion. Methotrexate was more commonly used as the immunomodulator compared to azathioprine.

Conclusion: A dramatic increase in the use of immunomodulators with pegloticase was observed in 2019, most likely sparked by a case series presented in November 2018 that showed a marked improvement in treatment response rate with methotrexate/pegloticase co-therapy^4,5 compared to pegloticase alone.² Therefore, physicians appear to be using DMARDs with increasing frequency in patients with uncontrolled gout who are treated with pegloticase to potentially maximize treatment response rates. Controlled trials are currently ongoing to further validate this therapeutic approach.

References:

1. Lipsky PE, et al. Arthritis Res Ther 2014;16:R60.
2. Sundy JS, et al. JAMA 2011;306:711-20.
3. Krieckaert CL, et al. Arthritis Res Ther 2010;12:217.
4. Botson J, Peterson J. Arthritis Rheumatol. 2018;70 (suppl 10).
5. Botson J, Peterson J. Ann Rheum Dis. 2019;78: A1289.
6. Albert J, et al. Arthritis Rheumatol 2019;71 (suppl 10).
7. Bessen SY, et al. Semin Arthritis Rheum 2019;49:56-61.
8. Botson J, et al. Ann Rheum Dis 2020, 79.

Note – Immunomodulation/pegloticase co-therapy usage defined as any patient starting either methotrexate or azathioprine within 60 days before or after their first pegloticase infusion, excluding immunotherapy usage one year before starting pegloticase.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/trends-in-immunomodulation-pegloticase-co-therapy-from-2015-2019-a-claims-database-study/