Pegloticase plus immunomodulatory drugs improves treatment persistence in gout
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Adding immunomodulatory therapy to pegloticase for gout improves treatment persistence, according to data from a large observational registry presented at ACR Convergence 2021.
“This retrospective analysis provides insights into the real-world use of pegloticase with immunomodulation for patients with uncontrolled gout,” Brian LaMoreaux, MD, MS, medical director of medical affairs at Horizon Therapeutics, told Healio Rheumatology. “The American College of Rheumatology’s Rheumatology Informatics System for Effectiveness (RISE) database is a large national database that many rheumatologists provide de-identified data for, though this database has not been leveraged to date to examine gout and pegloticase outcomes.”
“Recognizing that uncontrolled gout is a debilitating disease with long-term systemic consequences, it is important to maximize therapeutic options for patients,” he added. “Over the past few years, published literature has indicated that when pegloticase is used with an immunomodulator, the response rate can be significantly improved.”
To examine treatment persistence and adverse events in patients with gout who receive pegloticase (Krystexxa, Horizon Therapeutics) with concomitant immunomodulatory drugs, LaMoreaux, and colleagues conducted a retrospective cohort study of data from the RISE registry. Focusing on the period from January 2016 through June 2020, the researchers identified 700 patients from the registry with procedure codes for pegloticase. The first code date for each individual was defined as the index date.
Using this data, LaMoreaux and colleagues divided the pegloticase users into two groups based on concomitant immunomodulatory therapy. Immunomodulatory users were defined as those with at least one immunomodulatory prescription within 60 days of the index date. In all, 124 of the patients receiving pegloticase were included in the immunomodulatory treatment group, with the remaining 576 classified as non-immunomodulatory users.
The researchers calculated the proportion of patients who ever achieved a serum urate of 6 mg/dL or less, as well as those with laboratory abnormalities, within 180 days after the index date. In addition, they used a Cox regression model to analyze time to pegloticase discontinuation, controlling for age, sex, race, BMI, national area deprivation index, concurrent medications and number of medication risk categories — based on comorbidity based on drugs for specific diseases.
Among the patients who received concomitant immunomodulatory drugs, the most common was methotrexate, at 79%, followed by azathioprine, at 12.1%.
According to the researchers, 90% of patients met the serum urate target during follow-up. The median number of pegloticase infusions for those who used immunomodulatory therapy was seven, compared with five for non-users. In addition, those who received immunomodulatory treatment were less likely to discontinue pegloticase, compared with those who did not. After adjustment, the hazard ratio for pegloticase discontinuation associated with concomitant immunomodulatory therapy was 0.57 (95% CI, 0.43-0.78).
Approximately 5% of the total pegloticase group demonstrated laboratory abnormalities. This figure was not higher among those on immunomodulatory treatment.
“Gout is a chronic, systemic, and progressive disease that needs to be treated early and aggressively,” LaMoreaux said. “This new analysis of real-world experience of pegloticase from the ACR RISE database adds to the body of data supporting the effective and safe use of concomitant immunomodulation for this subset of patients and suggests using concomitant immunomodulation co-therapy improves pegloticase persistence. These findings are consistent with previous clinical trials and in-practice analyses.”
“This includes topline data recently announced from the MIRROR randomized controlled trial, which showed 71% of patients achieved a complete response rate using pegloticase with methotrexate, compared to a 40% response rate in patients who received pegloticase with placebo,” he added. “Horizon’s goal through the continued study of immunomodulatory therapy in use with pegloticase is to provide robust, controlled data to support clinicians as they seek to use evidence-based medicine to effectively reduce the urate burden and improve outcomes for patients living with uncontrolled gout.”
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Yun H. Abstract 1529. Presented at: ACR Convergence 2021; November 5-9, 2021 (virtual meeting).
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