Leflunomide Is Effective in the Treatment of Rheumatoid Arthritis
Joel M. Kremer
(64th Annual Meeting of the American College of Rheumatology) Results of a randomized, placebo-controlled, multicenter study showed that twice as many patients receiving both leflunomide and methotrexate for treatment of rheumatoid arthritis demonstrated significant therapeutic benefits compared with a control group receiving a placebo and methotrexate. The 24-week, multicenter trial included 263 patients with active rheumatoid arthritis who were unresponsive to treatment with methotrexate alone. Patients were randomized to receive 10 mg per day of leflunomide with methotrexate (130 patients; mean dose of 16.7 mg per week) or placebo with methotrexate (133 patients; mean dose of 16.2 mg per week). Dose adjustments were made depending on tolerability and efficacy. Forty-six percent of patients in the leflunomide group responded to the therapy while only 20 percent of patients in the control group responded to therapy. The researchers used the American College or Rheumatology’s (ACR) 20 percent response rate to assess the efficacy of the treatment at 24 weeks. The ACR criteria for response includes: (1) at least a 20 percent improvement in both tender and swollen joint count and (2) at least a 20 percent improvement in three of the following five criteria: patient’s assessment of disease activity, investigator’s assessment of disease activity, pain intensity, functional/disability measur, and acute phase reactants. The combination therapy was well tolerated; minor adverse effects included diarrhea, nausea and dizziness.–JOEL M. KREMER, Center for Rheumatology, Albany, New York.
COPYRIGHT 2001 American Academy of Family Physicians
COPYRIGHT 2001 Gale Group