Sulfasalazine has a better efficacy/toxicity profile than auranofin--evidence from a 5 year prospective, randomized trial.

OBJECTIVE: To compare results of medium to longterm sulfasalazine and auranofin treatment in active rheumatoid arthritis (RA). METHODS: 200 patients with active RA were enrolled in a prospective, randomized trial comparing sulfasalazine (target dosage, 40 mg/kg/day) with auranofin (6-9 mg/day). Patients were assessed annually for 5 years, using clinical and laboratory measures of disease activity. Risk of discontinuing treatment was compared using life table analysis. RESULTS: 31% of patients continued sulfasalazine for at least 5 years, compared to only 15% continuing auranofin (p < 0.05). Patients previously given intramuscular (i.m.) gold did particularly badly during auranofin treatment (only 1/26 continued therapy for 5 years), but after excluding all patients previously treated with i.m. gold from both groups more patients continued sulfasalazine for > 5 years (p < 0.05). Patients continuing therapy at 5 years had significantly milder disease at enrollment than those who did not. The patients continuing auranofin treatment at 5 years were no better than at the outset of the trial, and may represent a subgroup of patients with a good prognosis. Patients continuing sulfasalazine, however, showed sustained response over the 5 year period. CONCLUSION: Sulfasalazine therapy was more likely to be continued for 5 years, suggesting better tolerability and/or efficacy than auranofin, and produced evidence of continuing benefit. Patients previously withdrawn from i.m. gold therapy because of inefficacy or minor toxicity should not be given auranofin therapy.