Comparison of auranofin, gold sodium thiomalate, and placebo in the treatment of rheumatoid arthritis

Abstract

A prospective controlled, double-blind multicenter trial compared placebo, auranofin (an orally administered gold complex), and parenteral gold sodium thiomalate (GST) in patients with active rheumatoid arthritis (RA). Of 193 patients who received any treatment, the only important improvement identified for either auranofin or GST was for pain/tenderness scores. When 161 patients who completed 20 weeks of treatment were examined, both auranofin and GST treatments were superior to placebo as measured by improvement in number of painful and/or tender joints, joint pain/tenderness scores, physician's assessment of disease activity, and decrease in erythrocyte sedimentation rate when elevated at entry. GST was superior to placebo in improvement of joint swelling scores, anemia, thrombocytosis, and rheumatoid factor. No drug-related remissions were observed. The only statistically significant advantages of GST over auranofin for efficacy were an increase in hemoglobin concentration and decrease of thrombocytosis with GST. Withdrawals for adverse effects were 5 times more frequent with GST treatment. Thrombocytopenia, proteinuria, elevated liver enzymes, "nitritoid" reactions, and "gold pneumonitis" were observed only in the GST treatment group. These results confirm that both parenteral and oral gold may be effective for the treatment of RA, that GST tends to show greater efficacy than auranofin, and that auranofin has fewer significant adverse effects than GST. However, long-term benefits, tolerability, and safety cannot be inferred from this study.

The stability of health status in rheumatoid arthritis: a five-year study of patients with established disease.

“…Two different patient populations were involved: 51 per cent were from clinical settings where they were receiving routine specialty care while 49 per cent were initially involved in a 21-week cooperative drug trial which compared placebo, oral gold, and injectable gold. 9 Since the study was not designed to assess the effect of treatment, there were no restrictions on therapy and no data were collected on which drugs patients had taken.…”

Outcome assessment in clinical trials evidence for the sensitivity of a health status measure

“…A comprehensive description of the study design is provided elsewhere (22). In brief, the trial was conducted at 10 university rheumatology centers under the auspices of the NIH-sponsored Cooperative Systematic Studies of Rheumatic Diseases project.…”

Clinical pharmacology of gold

“…Comparison of Auranofin versus gold sodium thiomalate in this study (Ward et al, 1983), demonstrated that the injectable gold sodium thiomalate was superior to the oral gold drug for improvement in anaemia and thrombocytosis. Both Auranofin and gold sodium thiomalate were superior to placebo for improvement in number of tender joints, joint pain/tenderness score, physicians overall assessment and ESR.…”

“…However, a related compound 2,3,4,6-tetra-o-acetyll-thio-ß-D-glucopyranosato-S-(triethylphosphine) gold (Auranofin) was shown to exhibit antiarthritic properties . Subsequent studies demonstrated that this compound was beneficial in the treatment of rheumatoid arthritis (Ward, 1983;Finkelstein, 1976).…”

“…In 1983 Ward and his colleagues who comprised the Cooperative Systematic Studies of Rheumatic Diseases group reported a prospective controlled double-blind multi-centre trial which compared placebo, Auranofin and gold sodium thiomalate (Ward et al, 1983). Of the 208 patients who fulfilled entry criteria, 193 were eligible for study and 161 patients completed 20 weeks of therapy.…”