Methotrexate-Pegloticase Combination in Refractory Gout - MIRROR Study Save
The MIRROR study, an open-label pilot trial in refractory, uncontrolled gout patients, showed that pegloticase given in combination with methotrexate was safe and effective and maintained responses for 6 months after initiation.
A total of 14 patients were enrolled with a mean serum uric acid (sUA) of 9.2 mg/dL and 12/14 patients had tophi. Patients were given oral methotrexate (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 (sUA <6 mg/dL) for ≥80% of the time during at weeks 20, 22, and 24.
At 6 months, 11 patients (78.6%) qualified as responders and 3 patients discontinuing treatment for pre-infusion sUA values greater than 6 mg/dL for 2 consecutive scheduled visits. No new safety concerns were identified.
These results suggest that adding MTX to PEG yields higher than expected numbers of responders as the registration trials for PEG reported 42% response rates.
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