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

Arthritis Rheum. 1996 Dec;39(12):2021-7. doi: 10.1002/art.1780391211.


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.

Conclusion: SSZ at a dosage of 2,000 mg/day is well tolerated and effective in patients with chronically active ReA.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Anti-Inflammatory Agents / adverse effects
  • Anti-Inflammatory Agents / therapeutic use*
  • Arthritis, Reactive / drug therapy*
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Patient Compliance
  • Placebos / therapeutic use*
  • Prohibitins
  • Sulfasalazine / adverse effects
  • Sulfasalazine / therapeutic use*
  • Treatment Outcome
  • Treatment Refusal


  • Anti-Inflammatory Agents
  • PHB2 protein, human
  • Placebos
  • Prohibitins
  • Sulfasalazine