Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease. Therapy is based on disease-modifying agents. Methotrexate (MTX) is used in first-line therapy and, in the case of failure, its alternatives include leflunomide, which was recommended in Poland within the National Health Fund Therapeutic Program.
Objectives: The purpose of the study was to evaluate the parameters of quality of life of Polish patients with high RA activity during treatment with leflunomide. Additional aims were to evaluate the effectiveness and safety of treatment.
Material and methods: We performed a retrospective analysis of the data from the PLUS study. The PLUS study comprised 887 adult patients from 30 centers. During the study patients received leflunomide in a maintenance dose of 20 mg or 10 mg once daily. Before the study, 100 mg of leflunomide had been administered daily for 3 days, followed by a maintenance dose of 20 mg/day or 10 mg/day for at least a month before enrollment. The PLUS study observation time was up to 12 months with 1 control visit every 3 months. The patients' quality of life was assessed with Health Assessment Questionnaire Disability Index (HAQ-DI). Erythrocyte sedimentation rate (ESR), Disease Activity Score (DAS28) and CRP (C-reactive protein) concentration were used to assess the disease activity.
Results: Six hundred seventy-nine patients completed the study. The HAQ-DI decreased after 3 months of observation (mean value 1.46 vs baseline 1.63; p = 0.001) and remained stable. The percentage of patients with HAQ-DI less than 1 and greater than 2 increased from 12.2% to 17.8% and decreased from 33.2% to 20.3%, respectively (p < 0.0001); DAS28 progressively decreased on subsequent visits. C-reactive protein and ESR decreased after 3 months and remained stable. Adverse events were observed in 4.4% of patients.
Conclusions: Treatment with standard leflunomide doses is safe and allows for significant clinical improvement.
Keywords: disease-modifying antirheumatic drugs; leflunomide; rheumatoid arthritis.