Sulfasalazine in the treatment of juvenile chronic arthritis: a randomized, double-blind, placebo-controlled, multicenter study. Dutch Juvenile Chronic Arthritis Study Group.
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.


CONCLUSIONS
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.
van Rossum
M A
MA
Leiden University Hospital, The Netherlands.
Fiselier
T J
TJ
Franssen
M J
MJ
Zwinderman
A H
AH
ten Cate
R
R
van Suijlekom-Smit
L W
LW
van Luijk
W H
WH
van Soesbergen
R M
RM
Wulffraat
N M
NM
Oostveen
J C
JC
Kuis
W
W
Dijkstra
P F
PF
van Ede
C F
CF
Dijkmans
B A
BA
D000293:Adolescent; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D001175:Arthrography; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007596:Joints / Q000473:pathology / Q000503:physiopathology; D008297:Male; D011446:Prospective Studies; D012449:Safety; D012720:Severity of Illness Index; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D012460:Sulfasalazine