Results of phase III MIRROR trial of Krystexxa in gout published in Arthritis & Rheumatology
Horizon Therapeutics announced the publication of data from the MIRROR randomized controlled clinical trial of Krystexxa (pegloticase) injection with methotrexate, a commonly used immunomodulator, in Arthritis & Rheumatology [https://doi.org/10.1002/art.42335]
The co-administration of Krystexxa with an immunomodulator like methotrexate has increasingly been employed for patients with uncontrolled gout (chronic gout refractory to oral therapies) to help reduce the development of anti-drug antibodies, which can affect treatment efficacy. Following a series of case studies and an open-label study, the MIRROR randomized controlled trial (Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving Krystexxa trial, NCT03994731) was conducted and evaluated differences in treatment response for Krystexxa with methotrexate compared to Krystexxa with placebo.
The Month 6 MIRROR randomized controlled trial results included the following results. Greater than 30 percentage-point increase in patient response rate during Month 6 (p<0.0001): 71% (71 of 100) of patients randomized to receive krystexxa with methotrexate vs 39% (20 of 52) of patients randomized to receive krystexxa with placebo achieved the primary efficacy endpoint. marked reduction in infusion reactions: during the treatment period, 4% (4 of 96) of patients who received krystexxa with methotrexate experienced infusion reactions vs 31% (15 of 49) of patients who received krystexxa with placebo. no new safety signals were observed. over a 20 percentage-point increase in the complete resolution of at least one tophus at week 24 (p="0.043):" among patients with validated tophi at baseline, 35% (18 of 52) of patients who were randomized to receive krystexxa with methotrexate had complete resolution of at least one tophus at week 24 vs 14% (4 of 29) of patients who were randomized to receive krystexxa with placebo.
See: "A Randomized Placebo-Controlled Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled GOut Receiving Pegloticase (MIRROR RCT): Primary Efficacy and Safety Findings" John K. Botson et al. Arthritis & Rheumatology 13 September 2022 https://doi.org/10.1002/art.42335
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