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.