Auranofin versus placebo in the treatment of rheumatoid arthritis.

In a six-month, multicenter, double-blind study involving 340 patients, auranofin, 3 mg twice daily, was compared with placebo in the treatment of adult-onset rheumatoid arthritis. All patients were continued on a therapeutic regimen of salicylates and/or a newer nonsteroidal anti-inflammatory drug. Patients in both treatment groups who completed six months of therapy with coded medications showed significant improvement in the clinical features of rheumatoid arthritis (that is, number of tender and swollen joints, severity of pain, grip strength and duration of morning stiffness); however, the mean improvement was greater in the auranofin-treated group. Fifty-two percent of the auranofin-treated patients compared with 24 percent of the placebo-treated patients (p less than 0.05) were judged by their physician to have shown marked or moderate improvement. Only in the auranofin-treated patients was there significant improvement from baseline in the laboratory parameters of disease activity: erythrocyte sedimentation rate, IgA, IgG, and IgM. After at least three months of therapy, 30 percent (46 of 152) of the placebo-treated patients but only 9 percent (13 of 152) of the auranofin-treated patients (p less than 0.05) withdrew from coded medication due to insufficient therapeutic effect. Study medication was discontinued by 5 percent (eight of 152) of the auranofin-treated patients and 3 percent (four of 152) of the placebo-treated patients because of adverse therapy events (p = 0.24). This study demonstrates the efficacy of auranofin when added to salicylates and/or nonsteroidal anti-inflammatory drugs in the treatment of rheumatoid arthritis.