[Sulfasalazine in the treatment of rheumatoid arthritis. A multicenter open study of 150 patients during 6 months]

Abstract

One hundred and fifty patients with rheumatoid arthritis were given sulfasalazine in a daily dosage of 2 g during an open-label, multicenter, six-month trial. Improvements were apparent as early as four weeks after initiation of the drug. Improvements in clinical parameters and erythrocyte sedimentation rate were statistically significant. In the patients who remained on the study protocol, clinical and biological improvements continued over time and were more marked after six months. Overall clinical safety was satisfactory: 30 patients were withdrawn from the trial for adverse events, all of which resolved after discontinuation of the study drug. Most of these adverse events (93%) developed within two months of initiation of the drug, demonstrating the need for hematologic and hepatic tests at regular intervals during the first three months of sulfasalazine therapy. Thirty-four patients had not previously received maintenance therapy; in this subgroup, only one patient was withdrawn for ineffectiveness. In view of its favorable risk/benefit ratio and fast action, sulfasalazine may be a useful first-line drug in patients with rheumatoid arthritis.