Key clinical point: A nearly 50% reduction in methotrexate dose at the time of initiating a tumor necrosis factor inhibitor (TNFi) is possible in patients with rheumatoid arthritis (RA) who had an inadequate response to the initial maximum tolerated dose of methotrexate.
Major finding: Reduced-dose methotrexate+adalimumab was noninferior to maximal-dose methotrexate+adalimumab in achieving Simplified Disease Activity Index-based remission at week 48 (adjusted risk difference 6.4%; 90% CI −7.0% to 19.8%) and less frequently caused adverse events after 24 weeks (20% vs 35%). No deaths were reported.
Study details: Findings are from the MIRACLE trial including 291 methotrexate-naive patients with RA and inadequate response to the maximum tolerated methotrexate dose who were randomly assigned to initiate adalimumab in combination with the maximum tolerated dose or a reduced dose of methotrexate.
Disclosures: This study was funded by Eisai. Three authors declared being employees and shareholders of Eisai. Several authors declared receiving speaker honoraria, grants, research support, consulting fees, or royalties from Eisai and other sources.
Source: Tamai H et al and MIRACLE study collaborators. Reduced versus maximum tolerated methotrexate dose concomitant with adalimumab in patients with rheumatoid arthritis (MIRACLE): A randomised, open-label, non-inferiority trial. Lancet Rheumatol. 2023;5(4):E215-E224 (Apr). Doi: 10.1016/S2665-9913(23)00070-X