Combination disease-modifying antirheumatic drug therapy reduced work disability in early rheumatoid arthritis.

M e t h o d s Design: Randomized controlled trial (Finnish Rheumatoid Arthritis Combination Therapy trial). Allocation: {Concealed}†.* Blinding: Blinded {outcome assessors}†.* Follow-up period: 5 years. Setting: 18 hospitals in Finland. Patients: 162 patients 18 to 65 years of age (mean age 45.5 y, 62% women) with RA of recent onset (< 2 y) and presence of active disease who had never received DMARDs and were still working or potentially employable. Intervention: Combination therapy with DMARDs (simultaneous sulfasalazine, 500 to 1000 mg twice/d; methotrexate, 7.5 to 15 mg/wk; hydroxychloroquine, 300 mg/d; plus prednisolone, 5 to 10 mg/d) (combinationtherapy group, n = 80) or single therapy with a DMARD (initially sulfasalazine, 2 to 3 g/d, which was replaced with methotrexate 7.5 to 15 mg/wk if clinical response was < 25% at 6 mo) with or without prednisolone (singletherapy group, n = 82). After 2 years, the drug treatment strategy was no longer restricted and patients with inadequate response to single DMARD therapy were allowed to switch to combination DMARD therapy. Outcomes: Cumulative duration of all work disability (sick leaves plus RA-related disability pensions) was obtained from social insurance registers or case records. Patient follow-up: 97.5%.