Comparison of sulfasalazine and placebo in the treatment of reactive arthritis (Reiter's syndrome). A Department of Veterans Affairs Cooperative Study.
OBJECTIVE
To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective in the treatment of reactive arthritis (ReA) that has been unresponsive to nonsteroidal antiinflammatory drug (NSAID) therapy.


METHODS
One hundred thirty-four patients with ReA who had failed to respond to NSAIDs were recruited from 19 clinics, randomized (double-blind) to receive either SSZ or placebo, and followed up for 36 weeks. The definition of treatment response was based on joint pain/tenderness and swelling scores and physician and patient global assessments.


RESULTS
Longitudinal analysis revealed improvement in the patients taking SSZ compared with those taking placebo, which appeared at 4 weeks and continued through the trial (P = 0.02). At the end of treatment, response rates were 62.3% for SSZ treatment compared with 47.7% for placebo treatment. The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints.


CONCLUSIONS
SSZ at a dosage of 2,000 mg/day is well tolerated and effective in patients with chronically active ReA.
Clegg
D O
DO
VAMC, Salt Lake City, Utah, USA.
Reda
D J
DJ
Weisman
M H
MH
Cush
J J
JJ
Vasey
F B
FB
Schumacher
H R
HR
Budiman-Mak
E
E
Balestra
D J
DJ
Blackburn
W D
WD
Cannon
G W
GW
Inman
R D
RD
Alepa
F P
FP
Mejias
E
E
Cohen
M R
MR
Makkena
R
R
Mahowald
M L
ML
Higashida
J
J
Silverman
S L
SL
Parhami
N
N
Buxbaum
J
J
Haakenson
C M
CM
Ward
R H
RH
Manaster
B J
BJ
Anderson
R J
RJ
Henderson
W G
WG
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016918:Arthritis, Reactive / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010919:Placebos / Q000627:therapeutic use*; D000091402:Prohibitins; D012460:Sulfasalazine / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D016312:Treatment Refusal
D000893:Anti-Inflammatory Agents; C000717331:PHB2 protein, human; D010919:Placebos; D000091402:Prohibitins; D012460:Sulfasalazine