Efficacy and safety of auranofin in patients with active early rheumatoid arthritis.

The efficacy and safety of auranofin, an oral gold compound, were investigated for the treatment of patients with active early rheumatoid arthritis (RA). The 48 patients enrolled in the study had RA that satisfied the diagnostic standards set in 1987 by the American College of Rheumatology, was of less than 5 years' duration, and was of stage I or II and class 1 or 2 according to the Steinbrocker system. Auranofin 3 mg was administered orally twice daily for 12 months. All patients also received nonsteroidal anti-inflammatory drugs as a basic therapy. Some patients also received steroids, although the dose was limited to < 5 mg/d prednisolone equivalent. No other disease-modifying antirheumatic drug (DMARD) was administered. On the first day of the trial and after 3, 6, and 12 months of treatment, clinical symptoms, modified Lansbury index, C-reactive protein, erythrocyte sedimentation rate, rheumatoid factor, and the patients' assessments of severity of pain, judged using a visual analog scale, were evaluated. All of these measurements had improved significantly after 12 months of treatment. Moreover, no adverse events were observed during the treatment period. Therefore, the results confirm that auranofin is an effective and safe DMARD and is useful as a first-line therapy in the treatment of patients with RA.