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

    June 2013 in “ Annals of the rheumatic diseases ”
    Gerd R. Burmester, A. Kivitz, Ronald F. van Vollenhoven, S. Florentinus, P.M. Karunaratne, H. Küpper, Maxime Dougados, Roy Fleischmann
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    Studysummary This study concluded that while methotrexate-related adverse events were infrequent in early rheumatoid arthritis patients taking adalimumab, some increased with higher methotrexate doses, suggesting use of the lowest effective dose. Our plain-language summary of this paper — not a Tressless recommendation.
    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.
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