SULFASALAZINE IN THE TREATMENT OF JUVENILE CHRONIC ARTHRITIS - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY

Objective. To assess the efficacy, tolerability, and safety of sulfasa lazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Met hods. we conducted a 24-week randomized, placebo-controlled, double-bl ind, multicenter study of patients with active JCA of both oligoarticu lar and polyarticular onset. Patients were treated with a dosage of 50 mg/kg/day of SSZ (maximum 2,000 mg/day) or placebo. The efficacy vari ables were joint scores, physician's, parents', and patient's overall assessments, and laboratory parameters of inflammation. Results, Of th e 69 patients enrolled, 52 (75%) completed the trial. Six patients (18 %) withdrew from the placebo group, and 11 (31%) withdrew from the SSZ group (P = 0.18), In the intention-to-treat analysis of end point eff icacy, between-group differences were significant for the overall arti cular severity score (P = 0.02), all global assessments (P = 0.01), an d the laboratory parameters (P < 0.001), Adverse events occurred more frequently in the SSZ group and were the main reason for withdrawal (P < 0.001), but in all instances, these events were transient or revers ible upon cessation of treatment. Conclusion, The results of this firs t placebo-controlled study show that SSZ is effective and safe in the treatment of children with oligoarticular- and polyarticular-onset JCA , although it was not well tolerated in one-third of the patients.