Sulfasalazine in the treatment of juvenile chronic arthritis: A randomized, double-blind, placebo-controlled, multicenter study

Autor: B. A. C. Dijkmans, R. ten Cate, W. H. J. Van Luijk, M. A. J. van Rossum, P F Dijkstra, NM Wulffraat, A. H. Zwinderman, Theo J. W. Fiselier, W. Kuis, L.W.A. van Suijlekom-Smit, Johanna C. M. Oostveen, M.J.A.M. Franssen, R. M. van Soesbergen, C. F. P. Van Ede
Přispěvatelé: General Paediatrics, AII - Amsterdam institute for Infection and Immunity, Epidemiology and Data Science, APH - Methodology
Rok vydání: 1998
Předmět:
Zdroj: Arthritis and rheumatism, 41(5), 808-816. John Wiley and Sons Inc.
Arthritis and Rheumatism, 41, 808-816
Arthritis and Rheumatism, 41, 5, pp. 808-816
ISSN: 1529-0131
0004-3591
DOI: 10.1002/1529-0131(199805)41:5<808::aid-art6>3.0.co;2-t
Popis: Objective. To assess the efficacy, tolerability, and safety of sulfasalazine (SSZ) in the treatment of juvenile chronic arthritis (JCA). Methods. We conducted a 24-week randomized, placebo-controlled, double- blind, multicenter study of patients with active JCA of both oligoarticular 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 variables were joint scores, physician's, parents', and patient's overall assessments, and laboratory parameters of inflammation. Results. Of the 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 efficacy, between-group differences were significant for the overall articular severity score (P = 0.02), all global assessments (P = 0.01), and 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 reversible upon cessation of treatment. Conclusion. The results of this first 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.
Databáze: OpenAIRE
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