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 (do...

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Published in:Arthritis and rheumatism 1996-12, Vol.39 (12), p.2013-2020
Main Authors: Clegg, Daniel O., Reda, Domenic J., Mejias, Edwin, Cannon, Grant W., Weisman, Michael H., Taylor, Thomas, Budiman‐Mak, Elly, Blackburn, Warren D., Vasey, Frank B., Mahowald, Maren L., Cush, John J., Schumacher, H. Ralph, Silverman, Stuart L., Alepa, F. Paul, Luggen, Michael E., Cohen, Miriam R., Makkena, Rama, Haakenson, Clair M., Ward, Richard H., Manaster, B. J., Anderson, Robert J., Ward, John R., Henderson, William G.
Format: Article
Language:English
Subjects:
Adult
Anti-Inflammatory Agents - adverse effects
Anti-Inflammatory Agents - therapeutic use
Arthritis, Psoriatic - drug therapy
Double-Blind Method
Female
Humans
Longitudinal Studies
Male
Middle Aged
Patient Compliance
Placebos - therapeutic use
Sulfasalazine - adverse effects
Sulfasalazine - therapeutic use
Treatment Outcome
Treatment Refusal
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Summary: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. Conclusion. 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.
ISSN:0004-3591
1529-0131
DOI:10.1002/art.1780391210