SULFASALAZINE IN PSORIATIC-ARTHRITIS - A RANDOMIZED, MULTICENTER, PLACEBO-CONTROLLED STUDY

A prospective double-blind, placebo-controlled, randomized study of 24 weeks duration was carried out comparing the efficacy and tolerabilit y of sulphasalazine (SSZ) versus placebo in patients with psoriatic ar thritis. A total of 120 patients were included in nine centres. All pa tients had active disease and fulfilled the criteria of definite psori atic arthritis of at least 3 months duration. They received either SSZ (2.0 g/day) or placebo. Efficacy variables included pain, patient's o verall assessment of joint and skin improvement, morning stiffness, Ri tchie articular index, ESR and CRP. An intention-to-treat (ITT) analys is was performed for the 117 patients who qualified (three patients di d not qualify due to missing data after baseline). A per-protocol anal ysis was performed for the 81 patients who completed the 6 months stud y period (SSZ = 38, placebo = 43). Major reasons for withdrawal were i nadequate response (SSZ = 4, placebo = 7) and adverse events (SSZ = 8, placebo = 12). Pain was the only statistically significantly differen t primary outcome variable at end point in favour of SSZ in the ITT an alysis. No significant differences were present in other clinical or b iological variables, although there was a trend in favour of SSZ for s ome variables. SSZ, at a dose of 2.0 g/day appeared to be a safe treat ment in patients with psoriatic arthritis. At this dosage, its efficac y was only demonstrated for the pain variable.