SULFASALAZINE IN THE TREATMENT OF SPONDYLARTHROPATHY - A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objective. To assess the efficacy and tolerability of sulfasalazine (S SZ) in the treatment of spondylarthropathy, Methods. We conducted a 6- month randomized, placebo-controlled, double-blind, multicenter study of patients with spondylarthropathy whose disease had remained active despite treatment with nonsteroidal antiinflammatory drugs, Patients w ere treated with SSZ (3 gm/day) or placebo. The primary efficacy varia bles were the physician's and patient's overall assessments, pain, and morning stiffness. End points were analyzed in the intent-to-treat an d completer patient populations; the time course of effect was analyze d in the completer patient population, Results. Of the 351 patients en rolled, 263 (75%) completed the 6-month treatment period. The withdraw al rates were 35 (20%) and 53 (30%) in the placebo and SSZ groups, res pectively, In the intent-to-treat analysis of end point efficacy, the between-treatment difference reached statistical significance only for 1 of the 4 primary outcome variables, the patient's overall assessmen t of disease activity, for which 60% of the patients taking SSZ improv ed by at least 1 point on a 5-point scale, in contrast to 44% of the p atients taking placebo, Laboratory markers of inflammation also showed statistically significant change in favor of SSZ, In subgroup analysi s, the most impressive effects were seen in patients with psoriatic ar thritis, both for the 4 primary efficacy variables and for secondary e fficacy variables such as the number of inflamed joints. Adverse event s were more frequent in the SSZ group than the placebo group, but all were transient or reversible after cessation of treatment, Conclusion. The results of this study show that SSZ had greater efficacy than pla cebo in the treatment of active spondylarthropathy, notably in patient s with psoriatic arthritis.