Pegloticase Use and Quality of Life in Uncontrolled Gout, with Brian LaMoreaux, MD

New research presented at the European Congress of Rheumatology (EULAR) 2023 annual meeting from the MIRROR trial is offering insight into the effects of pegloticase (Krystexxa) plus methotrexate on quality of life in patients with uncontrolled gout.

Presented at the conference by John Botson, MD, RPh, director of Rheumatology at the Orthopedic Physicians Alaska, results of the study provide an overview of the effects of pegloticase plus methotrexate was associated with improvements in quality of life as well as multiple disease indices.¹

“Pegloticase treatment resulted in meaningful improvements in both clinical measures and quality of life in patients with uncontrolled gout. Patients co-treated with methotrexate experienced greater improvements in HAQ-Pain and Health scores after 52 weeks of therapy, likely reflective of the higher urate-lowering response rate observed in the presence of methotrexate immunomodulation,” wrote investigators.¹

Since the US Food and Drug Administration’s approval of the supplemental Biologics License Application for pegloticase (Krystexxa) plus methotrexate has been finding its role in the treatment algorithms of patients with uncontrolled gout. This approval, which occurred in 2022, was based on data from the phase 4 MIRROR trial.²

In the EULAR 2023 study, Botson and a team of investigators sought to examine the impact of pegloticase plus methotrexate on quality of life and prespecified patient-reported outcomes from within the trial. The specific outcomes of interest for the analysis were change from baseline to week 52 in Health Assessment Questionnaire (HAQ) indices, Physician Global Assessment of Gout (PhGA), and tender/swollen joint counts, with decreases in measures reflecting improvement for PhGA as well as tender/swollen joint counts.¹

Upon analysis, results suggested all HAQ measures improved during the study However, investigators pointed out the treatment group difference in the week 52 change from baseline in HAQ-disability was not statistically significant, which investigators suggest makes further PRO analyses exploratory. Further analysis suggest the PhGA score improved from baseline to week 52 (-4.2±0.2 vs -3.8±0.3), with a median observed score of 1.0 and 1.0 in the methotrexate and placebo groups, respectively, at week 52. Additionally, the number of tender/swollen joints declined significantly throughout the study period.¹

With an interest in learning more about this study and how results can help guide the care of patients with uncontrolled gout, we sat down with Brian LaMoreaux, MD, medical director of Horizon Therapeutics, to learn more.

Disclosures: Dr. LaMoreaux is a shareholder and employee of Horizon Therapeutics.

References:

1. Botson J, Obermeyer K, LaMoreaux B, et al. QUALITY OF LIFE AND CLINICAL GOUT ASSESSMENT CHANGES IN UNCONTROLLED GOUT PATIENTS UNDERGOING PEGLOTICASE THERAPY AS PART OF THE MIRROR RANDOMIZED CONTROLLED TRIAL. Paper presented at: European Congress of Rheumatology (EULAR) 2023. Milan, Italy. May 31 - June 3, 2023.
2. Pine L. FDA approves pegloticase injection plus methotrexate for patients with uncontrolled gout. HCP Live. July 8, 2022. Accessed June 1, 2023. https://www.hcplive.com/view/fda-approves-pegloticase-injection-plus-methotrexate-for-patients-with-uncontrolled-gout.