Initial combination therapy with prednisone or infliximab improved outcomes in early rheumatoid arthritis more than DMARDs alone

摘要

QuestionnnIn patients with early rheumatoid arthritis (RA), which treatment regimen is most effective for prevention of joint damage and functional decline? nnMethodsnnDesign: Randomized controlled trial.nnAllocation: Concealed.*nnBlinding: Blinded (outcome assessors).*nnFollow-up period: 1 year.nnSetting: 20 hospitals in western Netherlands.nnPatients: 508 patients 18 years of age (mean age 54 y, 68% women) with active RA for 2 years and no previous treatment with a disease-modifying antirheumatic drug (DMARD).nnIntervention: Group 1 (n = 126): sequential monotherapy with methotrexate (MTX) 15 mg/wk, followed stepwise, if Disease Activity Score in 44 joints (DAS44) > 2.4, by MTX 25 to 30 mg/wk, then monotherapy with sulfasalazine (SSZ) 2000 to 3000 mg/d, and then leflunomide 20 mg/d. Group 2 (n = 121): step-up combination therapy starting with MTX as above, then, if DAS44 still > 2.4, addition of SSZ, then hydroxychloroquine 400 mg/d, and then prednisone 7.5 mg/d. Group 3 (n = 133): combined therapy with prednisone 60 mg/d (tapered in 7 wk to 7.5 mg/d), MTX 7.5 mg/wk (increased to 25 to 30 mg/wk if DAS44 > 2.4), and SSZ 2000 mg/d. Group 4 (n = 128): combined therapy with infliximab 3 mg/kg at week 0, 2, and 6, then every 8 weeks (dose was increased stepwise if DAS44 > 2.4, up to 10 mg/kg) and MTX 25 to 30 mg/wk. Treatment adjustments were guided by DAS44, which was measured every 3 months. For responding patients, drugs were tapered to monotherapy at a maintenance dose; treatment could be reintroduced if disease activity flared.nnOutcomes: Change in joint damage in the hands and feet assessed by radiography (erosion score [0 to 280], joint space narrowing score [0 to 168], and total of the 2 scores), functional disability (assessed by the Health Assessment Questionnaire [0 to 3]), clinical remission (DAS44 < 1.6), and adverse events.nnPatient follow-up: 92% to 97% (intention-to-treat analysis).