Oral Gold vs. Sulfasalazine: Lackluster Performance
ABSTRACT & COMMENTARY
Synopsis: More subjects with rheumatoid arthritis discontinued auranofin than discontinued sulfasalazine in an open-label, randomized, prospective trial lasting five years. Diarrhea was the most frequent adverse effect with auranofin, while rash most often led to discontinuation of sulfasalazine.
Source: McEntegart A, et al. J Rheumatol 1996;23: 1887-1890.
Two hundred patients, predominantly female, with rheumatoid arthritis of about 10 years duration and with a mean age of about 56 years, were randomized to receive either auranofin or sulfasalazine in an open-label study that lasted five years. Efficacy measures were Ritchie joint index, duration of morning stiffness, pain, erythrocyte sedimentation rate (ESR), and C- reactive protein (CRP). The most striking difference was the larger number of withdrawals due to toxicity in the auranofin group (49) vs. the sulfasalazine group (24). While there were more withdrawals due to lack of efficacy in the sulfasalazine group (34) than for auranofin (26), overall there were more withdrawals from the auranofin than the sulfasalazine group. (See Figure.) Leukopenia developed in six subjects while on sulfasalazine and in three on auranofin. One auranofin-treated subject developed thrombocytopenia. All the hematologic toxicity resolved with the discontinuation of the offending drug. None of the three deaths in the sulfasalazine group or four deaths in the auranofin group were due to adverse drug effects. There were no significant differences in efficacy when articular index and duration of morning stiffness were compared between groups. Both agents produced significant decreases compared to baseline in articular index, morning stiffness, ESR, and C-reactive protein at one year of study, but by five years, only sulfasalazine demonstrated a continued, statistically significant improvement in these variables compared to baseline. The authors point out that the small number of subjects remaining in the auranofin group may have led to a loss of statistical power.
COMMENT BY JERRY M. GREENE, MD
The open-label design of this study exposes it to potential observer bias. It is also important to point out that the authors enrolled patients who had previously received intramuscular gold injections, assigning those who had adverse effects or lack of therapeutic effect to the sulfasalazine group in a non-random fashion. The authors, recognizing this potential confounder, removed all the subjects previously treated with IM gold from their analysis and still found more subjects continuing sulfasalazine for five years than continuing auranofin. More toxicity, no better efficacythis does not sound like the Midas touch for oral gold.
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