Methotrexate (MTX) and pegloticase combination therapy was found to reduce the incidence of gout flares over a period of 12 months, according to study results presented at the American College of Rheumatology (ACR) Convergence, held virtually from November 5 to 9, 2020.

Researchers enrolled adult patients with gout from 6 sites. Key inclusion criteria were uncontrolled gout, defined as serum uric acid (sUA) of 6 mg/dL or greater, and either an intolerance to urate lowering therapy (ULT), functionally limiting tophaceous deposits, or sUA of 6 mg/dL or greater despite oral ULT. Mean sUA at baseline was 9.2 (SD, 2.5) mg/dL. Patients were initiated with 15 mg of oral MTX per week and 1 mg of folic acid daily for 4 weeks before the first pegloticase infusion, and continued with 8 mg of pegloticase therapy every 2 weeks for a total of 52 weeks with concomitant MTX and folic acid. Primary outcome was the percentage of responders at month 6, defined as sUA less than 6 mg/dL for at least 80% of the time.

Of a total of 14 patients (mean age, 49.3±8.7 years; 100% men) included in the analysis, 11 (78.6%) were considered 6-month pegloticase responders; 8 patients continued receiving pegloticase and MTX combination therapy and remained responders at 12 months. Mean sUA fell below the lower limit of detection 12 weeks after initiation of the first pegloticase infusion, and remained undetected until week 52. Gout flares occurred in 13 patients (92.9%) in the first 12 weeks and in 2 patients (25%) during weeks 36 to 52. More than 1 patient experienced adverse events, including diarrhea, nasopharyngitis, and sinusitis, during the study.


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“Responders at month 6 who remained on treatment continued to be responders at month 12 with sUA remaining below 1 mg/dL,” the researchers noted. Overall, MTX/pegloticase co-therapy was well tolerated and reduced incidence of gout flares over time.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Botson J, Peloso P, Obermeyer K, et al. A multicenter, efficacy and safety study of methotrexate to increase response rates in patients with uncontrolled gout receiving pegloticase (MIRROR): 12-month results of an open-label study. Presented at: ACR Convergence 2020; November 5-9, 2020. Abstract 0677.