COMPARISON OF SULFASALAZINE AND PLACEBO IN THE TREATMENT OF PSORIATIC-ARTHRITIS - A DEPARTMENT-OF-VETERANS-AFFAIRS COOPERATIVE STUDY

Objective. To determine whether sulfasalazine (SSZ) at a dosage of 2,0 00 mg/day is effective for the treatment of active psoriatic arthritis (PsA) resistant to nonsteroidal antiinflammatory drug therapy. Method s. Two hundred twenty-one patients with PsA were recruited from 15 cli nics, randomized (double-blind) to SSZ or placebo treatment, and follo wed up for 36 weeks. Treatment response was based on joint pain/tender ness and swelling scores and physician and patient global assessments. Results. Longitudinal analysis revealed a trend favoring SSZ treatmen t (P = 0.13). At the end of treatment, response rates were 57.8% for S SZ compared with 44.6% for placebo (P = 0.05). The Westergren erythroc yte sedimentation rate declined more in the PsA patients taking SSZ th an in those taking placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal comp laints, including dyspepsia, nausea, vomiting, and diarrhea. Conclusio n. SSZ at a dosage of 2,000 mg/day is well tolerated and may be more e ffective than placebo in the treatment of patients with PsA.