Objectives Evaluation of the efficacy and tolerance of sulphasalazine (SALAZOPYRIN EN-tabs) in the management of Reactive arthritis (ReA) triggered by a urogenital infection.
Methods We conducted an open randomised trial on 2 parallel groups of patients, 30 patients each during 12 months (30 treated with SALAZOPYRIN EN 1–2 g/day, versus 30 treated with NSAID or analgesics). Tolerability and safety were assessed with whole blood picture test for liver and renal function, gastro-intestinal (G-I) adverse effects, and other side effects. Every month the efficiency of treatment was checked by clinical and laboratory methods.
Results There were no significant differences in demographic, clinical and laboratory parameters among the two groups at the study entry. By the end of the study, there was evidence of significant improvement shown by pain score, ability of movement, and reduction in the acute phase response in sulphasalazine (SALAZOPYRINE EN) group. Adverse reactions in the sulphasalazine (SALAZOPYRINE EN) group (12% of patients) occurred mainly in the first ten weeks of treatment and were mild, reversible and did not require termination of therapy. In 1% of patients these were severe enough to stop treatment.
The NSAID group encountered adverse reactions in 27% of patients and 4% required termination of therapy.
Conclusion Sulphasalazine (SALAZOPYRINE EN) proved to be a good first choice as a second-line of a disease modifying antirheumatic drug because of its early efficacy (8 weeks), persistent efficacy and its good tolerance.