COMPARATIVE EFFICIENCY AND TOLERABILITY OF CURRENT THERAPIES FOR EARLY RHEUMATOID ARTHRITIS

Abstract

Objecti v e : to compare the efficiency and safety of four treatment regimens using methotrexate (MT), leflunomide (LEF), and a combination of MT and glucocorticoids (GC) for early rheumatoid arthritis (RA) (disease duration <2 years). Subjects and methods. 141 patients with early RA (of them there were 122 women; mean age 51 years; mean disease duration 7.8 months; mean DAS28 6.0) were randomized to 4 treatment groups: 1) MT 10–20 mg/week (n = 35); 2) MT 10–20 mg/week + oral GC equivalent to 10 mg/day of prednisolone (n = 34); 3) MT 10–20 mg/week + oral CG + single intravenous administration of methylprednisolone (MP) 1000 mg at baseline (n = 35); 4) LEF 20 mg/day (n = 37). The patients were matched for main clinical and demographic characteristics. The duration of treatment was 1 year. Its efficiency was evaluated according to the European League Against Rheumatism (EULAR) criteria. Results . 125 patients completed one-year treatment. At this time, 11.4% of the patients achieved remission (DAS28 <2.6) in the MT group, 37.5% in the MT+GC group, 29.4% in the MT+GC+MP group, and 16.2% in the LEF group. Adverse events, mainly of mild intensity, were recorded in 9 patients in each MT group. A total of 7 patients had to discontinue treatment because of its inefficiency. Conclusion. All the four therapy regimens demonstrated a significant efficiency in patients with early RA; the total remission rate was 24%. The combination of MT and GC produced the most pronounced effect. The tolerability of treatment was good in all groups.