TY - JOUR
T1 - Sulfasalazine in the treatment of juvenile chronic arthritis
T2 - A randomized, double-blind, placebo-controlled, multicenter study
AU - Van Rossum, Marion A.J.
AU - Fiselier, Theo J.W.
AU - Franssen, Marcel J.A.M.
AU - Zwinderman, Aeilko H.
AU - Ten Cate, Rebecca
AU - Van Suijlekom-Smit, Lisette W.A.
AU - Van Luijk, Wilma H.J.
AU - Van Soesbergen, Renée M.
AU - Wulffraat, Nico M.
AU - Oostveen, Johanna C.M.
AU - Kuis, Wietse
AU - Dijkstra, Piet F.
AU - Van Ede, Clemens F.P.
AU - Dijkmans, Ben A.C.
PY - 1998/5
Y1 - 1998/5
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=0031969434&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/1529-0131(199805)41:5<808::AID-ART6>3.0.CO;2-T
DO - https://doi.org/10.1002/1529-0131(199805)41:5<808::AID-ART6>3.0.CO;2-T
M3 - Article
C2 - 9588731
SN - 0004-3591
VL - 41
SP - 808
EP - 816
JO - Arthritis and rheumatism
JF - Arthritis and rheumatism
IS - 5
ER -