Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): A randomized, controlled trial

TLDR

Several treatment strategies have proven value in ameliorating rheumatoid arthritis, but the optimal approach for preventing long‑term joint damage and functional decline remains unclear. The study aimed to compare clinical and radiographic outcomes of four distinct treatment strategies in early RA patients. A multicenter, randomized trial assigned 508 patients to sequential monotherapy, step‑up combination, initial combination with prednisone, or initial combination with infliximab, with therapy adjustments every three months to achieve low disease activity. After one year, patients receiving initial combination therapy with prednisone or infliximab achieved lower D‑HAQ scores (0.5 vs 0.7) and less radiographic progression (median Sharp/Van der Heijde scores 0.5–1.0 vs 2.0–2.5) than those on sequential monotherapy or step‑up combination, with no significant difference in adverse events.

Abstract

Several treatment strategies have proven value in the amelioration of rheumatoid arthritis (RA), but the optimal strategy for preventing long-term joint damage and functional decline is unclear. We undertook this study to compare clinical and radiographic outcomes of 4 different treatment strategies, with intense monitoring in all patients.In a multicenter, randomized clinical trial, 508 patients were allocated to 1 of 4 treatment strategies: sequential disease-modifying antirheumatic drug monotherapy (group 1), step-up combination therapy (group 2), initial combination therapy with tapered high-dose prednisone (group 3), and initial combination therapy with the tumor necrosis factor antagonist infliximab (group 4). Treatment adjustments were made every 3 months in an effort to obtain low disease activity (a Disease Activity Score in 44 joints of < or =2.4).Initial combination therapy including either prednisone (group 3) or infliximab (group 4) resulted in earlier functional improvement than did sequential monotherapy (group 1) and step-up combination therapy (group 2), with mean scores at 3 months on the Dutch version of the Health Assessment Questionnaire (D-HAQ) of 1.0 in groups 1 and 2 and 0.6 in groups 3 and 4 (P < 0.001). After 1 year, mean D-HAQ scores were 0.7 in groups 1 and 2 and 0.5 in groups 3 and 4 (P = 0.009). The median increases in total Sharp/Van der Heijde radiographic joint score were 2.0, 2.5, 1.0, and 0.5 in groups 1-4, respectively (P < 0.001). There were no significant differences in the number of adverse events and withdrawals between the groups.In patients with early RA, initial combination therapy including either prednisone or infliximab resulted in earlier functional improvement and less radiographic damage after 1 year than did sequential monotherapy or step-up combination therapy.