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 2,000 mg/day is effective for the treatment of active psoriatic arthritis (PsA) resistant to nonsteroidal antiinflammatory drug therapy.


METHODS
Two hundred twenty-one patients with PsA were recruited from 15 clinics, randomized (double-blind) to SSZ or placebo treatment, and followed up for 36 weeks. Treatment response was based on joint pain/ tenderness and swelling scores and physician and patient global assessments.


RESULTS
Longitudinal analysis revealed a trend favoring SSZ treatment (P = 0.13). At the end of treatment, response rates were 57.8% for SSZ compared with 44.6% for placebo (P = 0.05). The Westergren erythrocyte sedimentation rate declined more in the PsA patients taking SSZ than in those taking placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints, including dyspepsia, nausea, vomiting, and diarrhea.


CONCLUSIONS
SSZ at a dosage of 2,000 mg/day is well tolerated and may be more effective than placebo in the treatment of patients with PsA.
Clegg
D O
DO
VAMC, Salt Lake City, Utah, USA.
Reda
D J
DJ
Mejias
E
E
Cannon
G W
GW
Weisman
M H
MH
Taylor
T
T
Budiman-Mak
E
E
Blackburn
W D
WD
Vasey
F B
FB
Mahowald
M L
ML
Cush
J J
JJ
Schumacher
H R
HR
Silverman
S L
SL
Alepa
F P
FP
Luggen
M E
ME
Cohen
M R
MR
Makkena
R
R
Haakenson
C M
CM
Ward
R H
RH
Manaster
B J
BJ
Anderson
R J
RJ
Ward
J R
JR
Henderson
W G
WG
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010919:Placebos / Q000627:therapeutic use*; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D016312:Treatment Refusal
D000893:Anti-Inflammatory Agents; D010919:Placebos; D012460:Sulfasalazine