Methotrexate Dose Has Minimal Effects on Methotrexate-Related Toxicity in Patients with Early Rheumatoid Arthritis Treated in Combination with Adalimumab – Results of Concerto Trial

The CONCERTO trial evaluated the dose-response of methotrexate (MTX)-related toxicities in patients with early rheumatoid arthritis treated with adalimumab (ADA) and varying doses of MTX (2.5, 5, 10, or 20 mg). The study included 395 patients, with 358 completing the 26-week trial. The overall incidence of MTX-related adverse events (AEs) was low, though some AEs, such as infection and abnormal hair loss, appeared to increase with higher MTX doses. No significant differences were observed in hematologic or liver enzyme changes among the different MTX doses. The findings suggested that the lowest effective MTX dose in combination with ADA might be preferable to minimize AEs.