Comparison of sulfasalazine and placebo in the treatment of reactive arthritis (Reiter's syndrome). A department of veterans affairs cooperative study

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Abstract
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.

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