WESTPORT, CT (Reuters Health) – Leflunomide (LEF) is a safe and effective first-line treatment for active rheumatoid arthritis (RA), according to a report in the September issue of Arthritis and Rheumatism, and early improvements are sustained over 2 years without new or increased toxicity.
"Three 6- to 12-month, double-blind, randomized, controlled trials have shown leflunomide (LEF; 20 mg/day, loading dose 100 mg x 3 days) to be effective and safe for the treatment of RA," write Dr. Stanley Cohen, of St. Paul Medical Center in Dallas, Texas, and colleagues. They investigated whether the clinical benefit of leflunomide, as compared with methotrexate (MTX) treatment, was maintained over 24 months of treatment.
The study began with 98 patients treated with LEF, 36 treated with placebo, and 101 treated with MTX. The mean maintenance doses of LEF and MTX in year 2 were 19.6 mg/day and 12.6 mg/week, respectively.
Of the 199 patients who continued into the second year of treatment, 83 (85%) patients receiving LEF and 80 (79%) receiving MTX completed the 24 months, according to the report. The American College of Rheumatology (ACR) improvement response rates of at least 20% were higher in the LEF-treated patients than the MTX-treated patients, at 79% and 67%, respectively (p = 0.049).
"The mean change in total Sharp radiologic damage scores at year 2 compared with year 1 and baseline (LEF 1.6 versus MTX 1.2) showed statistically equivalent sustained retardation of radiographic progression in the active treatment groups," the investigators report.
The team found that 1.6% of LEF-treated patients, 1.6% of placebo-treated patients and 3.7% of MTX-treated patients experienced serious treatment-related adverse events.
Arthritis Rheum 2001;44:1984-1992
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