A double-blind study comparing sodium aurothiomalate and auranofin in patients with rheumatoid arthritis previously stabilized on sodium aurothiomalate.

Auranofin, an orally active gold preparation, was compared with sodium aurothiomalate in a double-blind trial in patients with rheumatoid arthritis fulfilling the ARA criteria, who had been stabilized on sodium aurothiomalate for at least six months. Twenty-four patients have so far been entered in the trial, of whom fourteen have been randomly allocated to receive auranofin and ten to receive sodium aurothiomalate. After initial stabilization, patients receive either auranofin 6 mg daily and placebo injection, or sodium aurothiomalate 50 mg monthly and placebo tablets. Five patients have completed one year on auranofin. The remaining nine patients were withdrawn because of loss of efficacy (two), side-effects, (five), loss of efficacy and side-effects (one) and default (one). Four patients have completed one year's treatment with sodium aurothiomalate. Of the remaining six patients, two were withdrawn because of side-effects, three because of poor disease control and one because of side-effects and poor disease control. Diarrhoea occurred in eight patients receiving auranofin. Rashes occurred in both groups but otherwise there were no serious side-effects. The efficacy of both drugs appeared similar, there being no significant differences in morning stiffness, fatiguability, visual analogue pain score, grip strength and articular index. There were also no significant differences in laboratory parameters of efficacy. Auranofin appears to control disease activity in rheumatoid arthritis but diarrhoea is a frequent side-effect.