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Comparison of sulfasalazine and placebo in the treatment of reactive arthritis (Reiter's syndrome). A Department of Veterans Affairs Cooperative Study.

AbstractOBJECTIVE:
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.
CONCLUSION:
SSZ at a dosage of 2,000 mg/day is well tolerated and effective in patients with chronically active ReA.
AuthorsD O Clegg, D J Reda, M H Weisman, J J Cush, F B Vasey, H R Schumacher Jr, E Budiman-Mak, D J Balestra, W D Blackburn, G W Cannon, R D Inman, F P Alepa, E Mejias, M R Cohen, R Makkena, M L Mahowald, J Higashida, S L Silverman, N Parhami, J Buxbaum, C M Haakenson, R H Ward, B J Manaster, R J Anderson, W G Henderson
JournalArthritis and rheumatism (Arthritis Rheum) Vol. 39 Issue 12 Pg. 2021-7 (Dec 1996) ISSN: 0004-3591 [Print] United States
PMID8961907 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)
Chemical References
  • Anti-Inflammatory Agents
  • PHB2 protein, human
  • Placebos
  • Prohibitins
  • Sulfasalazine
Topics
  • Adult
  • Anti-Inflammatory Agents (adverse effects, therapeutic use)
  • Arthritis, Reactive (drug therapy)
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Patient Compliance
  • Placebos (therapeutic use)
  • Prohibitins
  • Sulfasalazine (adverse effects, therapeutic use)
  • Treatment Outcome
  • Treatment Refusal

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