Horizon Therapeutics announced that Month 12 data from the MIRROR randomized controlled trial of KRYSTEXXA injection with methotrexate will be featured in Plenary I as part of the American College of Rheumatology Convergence 2022. Additional presentations include new imaging analyses describing the effects of urate-lowering therapy on joint health and vascular inflammation for people with chronic gout refractory to conventional therapies, also known as uncontrolled gout. This analysis extends the MIRROR randomized controlled trial body of data through Month 12 of treatment, showing a sustained patient response rate and similar safety profile to the Month 6 findings. Of patients randomized to receive KRYSTEXXA with methotrexate, 60% (60 of 100) achieved serum uric acid level less than 6 mg/dL for at least 80% of of the time during Month 12 treatment versus 30.8% for those randomized to receive KRYSTEXXA with placebo. Of patients with validated tophi at baseline, 53.8% in the KRYSTEXXA with methotrexate group had complete resolution of at least one tophus, no new tophus and no single tophus showing progression at Week 52 compared with 31.0% in the KRYSTEXXA with placebo group. Pharmacokinetic and immunogenicity findings through treatment Month 12 were consistent with Month 6 findings, indicating higher KRYSTEXXA exposure and lower KRYSTEXXA immunogenicity in those who received methotrexate co-therapy. 12-month Findings of the Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy and Safety Study of Methotrexate to Increase Response Rates in Patients with Uncontrolled GOut Receiving Pegloticase: Imaging studies demonstrate effect of aggressive urate-lowering therapy on urate deposits in the joints and vasculature: An imaging analysis from the MIRROR randomized controlled trial used dual-energy computed tomography to visualize and quantify monosodium urate crystal deposits, which are caused by elevated uric acid levels, in the hands, elbows, feet and knees of participating uncontrolled gout patients at specified timepoints throughout the 52-week treatment period. In total, eight participants were included in the imaging analysis. MSU volume had markedly decreased in both treatment groups at Week 52. These volume reductions were comparable in different regions of the same patients and occurred similarly with sustained urate-lowering in both treatment groups. Reduction in Monosodium Urate Crystal Deposit Volume During the MIRROR RCT Trial in Patients Treated with Pegloticase Plus Methotrexate Co-therapy: A Serial Dual-Energy Computed Tomography Analysis The Mount Sinai Hospital initiated a trial using DECT imaging and fluorodeoxyglucose positron emission tomography combined with computed tomography to quantify the presence of MSU deposits in the vasculature of uncontrolled gout patients and correlate this to vascular inflammation to further understand a possible link between uncontrolled gout and cardiovascular risk. In this analysis, ten patients with uncontrolled gout were treated with co-therapy of an immunomodulator and KRYSTEXXA every two weeks for up to six months. DECT and FDG-PET/CT scans were completed at baseline and after up to six months of treatment to detect vascular MSU deposition and arterial inflammation. The analysis found a statistically significant decrease in arterial inflammation after treatment across all arteries studied and a trend toward a decrease in MSU volume.
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