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DG DISPATCH - ACR: Adjuvant Leflunomide Effective For Rheumatoid Arthritis Unresponsive To Methotrexate By Maria Bishop Special to DG News PHILADELPHIA, PA -- November 1, 2000 -- Patients with rheumatoid arthritis who cannot find relief with traditional methotrexate therapy respond significantly to leflunomide adjuvant treatment, researchers have found. At the 64th Annual Scientific Meeting of the American College of Rheumatology (ACR) in Philadelphia, Pennsylvania, a multi-centre, double-blind, placebo-controlled study was described to support these claims. Over the course of 24 months, United States researchers at several centers across the country, led by Joel M. Kremer, MD, a rheumatologist at Albany Medical College, Albany, New York, examined 266 patients with active rheumatoid arthritis who were taking methotrexate without improvement of disease symptoms. The study was comprised of two arms. In the treatment arm, patients were randomized to receive leflunomide 100 mg daily for two days, followed by 10 mg daily. Dose adjustments were allowed. They also received a mean weekly dose of 16.7 mg of methotrexate. Patients in the placebo arm received mean doses of 16.2 mg per week of methotrexate only. Assessments were made every two weeks from baseline through week 8, and then every four weeks through week 24. The primary end point of this trial was an ACR20 response rate, indicating a 20 percent improvement in patient-reported tender joints and swollen joints, as well as three or more improved physician assessments using approved indices. At 24 weeks, 46.2 percent of participants in the treatment group had achieved an ACR20 response versus 19.5 percent of those in the placebo group. In addition, noted the researchers, using the "last observation carried forward" method of extrapolation, the ACR20, 50 and 70 response rates for the treatment group were 51.5 percent, 26.2 percent and ten percent, respectively. Side effects included diarrhea (22 percent for the treatment arm versus 10 percent for the placebo arm); nausea (12 percent and eight percent, respectively); and dizziness (five percent and two percent, respectively). This research was supported by Aventis Pharmaceuticals. Related Link: Aventis Pharmaceuticals. E-mail this page to a friend or colleague! To print, use this version