Pegloticase in Combination With Methotrexate in Patients With Uncontrolled Gout: A Multicenter, Open-label Study (MIRROR)
| Autor: | Howard M. Kenney, Katie Obermeyer, John K. Botson, Michael E. Weinblatt, John Tesser, Ralph Bennett, Jeff Peterson, Paul M. Peloso, Brian LaMoreaux |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Gout Urate Oxidase Immunology Placebo law.invention Gout Suppressants Polyethylene Glycols 03 medical and health sciences 0302 clinical medicine Rheumatology Randomized controlled trial law Internal medicine Immunology and Allergy Medicine Humans In patient 030212 general & internal medicine 030203 arthritis & rheumatology business.industry Middle Aged medicine.disease Discontinuation Uric Acid Clinical trial Methotrexate Treatment Outcome Pegloticase business medicine.drug |
| Zdroj: | The Journal of rheumatology. 48(5) |
| ISSN: | 0315-162X |
| Popis: | ObjectiveTo examine the efficacy and safety of pegloticase in combination with methotrexate (MTX) in patients with uncontrolled gout in an exploratory, open-label clinical trial (ClinicalTrials.gov: NCT03635957) prior to a randomized, controlled trial.MethodsA multicenter, open-label efficacy and safety study of pegloticase with MTX co-treatment was conducted in patients with uncontrolled gout. Patients were administered oral MTX (15 mg/week) and folic acid (1 mg/day) 4 weeks prior to and throughout pegloticase treatment. The primary study outcome was the proportion of responders, defined as serum uric acid (sUA) < 6 mg/dL for ≥ 80% of the time during Month 6 (Weeks 20, 22, and 24). All analyses were performed on a modified intent-to-treat population, defined as patients who received ≥ 1 pegloticase infusion.ResultsSeventeen patients were screened and 14 patients (all men, average age 49.3 ± 8.7 years) were enrolled. On Day 1, mean sUA was 9.2 ± 2.5 mg/dL, and 12 of the 14 patients had visible tophi. At the 6-month timepoint, 11/14 (78.6%, 95% CI 49.2–95.3%) met the responder definition, with 3 patients discontinuing after meeting protocol-defined treatment discontinuation rules (preinfusion sUA values > 6 mg/dL at 2 consecutive scheduled visits). All patients tolerated MTX. No new safety concerns were identified.ConclusionIn this study, an increased proportion of patients maintained therapeutic response at 6 months when treated concomitantly with MTX and pegloticase as compared to the previously reported 42% using pegloticase alone. These results support the need for a randomized study of MTX or placebo with pegloticase to validate these open-label findings. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|