Tolerance of methotrexate co-administered with pegloticase in patients with uncontrolled gout: overview of the findings from the mirror RCT

Stomatitis was rare (<i>n</i> = 1). Renal function remained stable in both groups. Liver function did not worsen among alcohol users and chronic kidney disease subgroups.</p> <p>MTX co-administration with pegloticase did not increase the incidence of liver dysfunction or infection in a post hoc analysis of MIRROR, suggesting that MTX was well tolerated in patients with uncontrolled gout.</p> <p><a target="_blank" href="clinicaltrials.gov/">https://clinicaltrials.gov/</a> identifier is NCT03994731.</p> <p>Gout is the most common form of inflammatory arthritis in the US.

Preferred treatments include therapies that lower serum urate levels, called urate-lowering therapies (ULTs). However, people who do not respond to or cannot take ULTs are at an increased risk of developing uncontrolled gout, which typically includes symptoms such as gout flares, tophi (swollen bumps under the skin), and persistent pain.Pegloticase is the first and only treatment approved by the US Food and Drug Administration for people with uncontrolled gout and is often taken together with methotrexate to reduce the development of antibodies that can increase the risk of infusion reactions and cause pegloticase to become less effective at lowering serum urate levels and improving symptoms.

However, some people have negative side effects when taking methotrexate, particularly those with advanced chronic kidney disease (CKD) and those who consume alcohol, leading healthcare providers to avoid or closely monitor the use of methotrexate in these patients.In this report of patients with uncontrolled gout who were treated with pegloticase and methotrexate, we describe the negative side effects seen in people with advanced CKD and people who used alcohol (1–3 drinks per week) to better understand if methotrexate is safe to use in these groups.

Overall, methotrexate was well tolerated; similar numbers and types of negative side effects were described, and liver and kidney function did not worsen. These findings support methotrexate as a medication that can be safely used in these groups with close supervision by a healthcare provider.</p>