Open AccessComparison of sulfasalazine and placebo in the treatment of ankylosing spondylitis. A department of veterans affairs cooperative study
Author(s) -
Clegg Daniel O.,
Reda Domenic J.,
Weisman Michael H.,
Blackburn Warren D.,
Cush John J.,
Can Grant W.,
Mahowald Maren L.,
Schumacher H. Ralph,
Taylor Thomas,
BudimanMak Elly,
Cohen Miriam R.,
Vasey Frank B.,
Luggen Michael E.,
Mejias Edwin,
Silverman Stuart L.,
Makkena Rama,
Alepa F. Paul,
Buxbaum Joel,
Haakenson Clair M.,
Ward Richard H.,
Manaster B. J.,
Anderson Robert J.,
Ward John R.,
Henderson William G.
Publication year - 1996
Publication title -
arthritis & rheumatism
Language(s) - English
Resource type - Journals
eISSN - 1529-0131
pISSN - 0004-3591
DOI - 10.1002/art.1780391209
Subject(s) - medicine , ankylosing spondylitis , placebo , sulfasalazine , erythrocyte sedimentation rate , arthritis , rheumatoid arthritis , adverse effect , gastroenterology , surgery , disease , pathology , ulcerative colitis , alternative medicine
Objective . To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective for the treatment of active ankylosing spondylitis (AS) that is not controlled with nonsteroidal antiinflammatory drug therapy. Methods . Two hundred sixty‐four patients with AS were recruited from 15 clinics, randomized (double‐blind) to SSZ or placebo treatment, and followed up for 36 weeks. Treatment response was based on morning stiffness, back pain, and physician and patient global assessments. Results . While longitudinal analysis revealed a trend favoring SSZ in the middle of treatment, no difference was seen at the end of treatment. Response rates were 38.2% for SSZ and 36.1% for placebo ( P = 0.73). The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo ( P < 0.0001). AS patients with associated peripheral arthritis showed improvement that favored SSZ ( P = 0.02). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints. Conclusion . SSZ at a dosage of 2,000 mg/day does not seem to be more effective than placebo in the treatment of AS patients with chronic, longstanding disease. SSZ is well tolerated and may be more effective than placebo in the treatment of AS patients with peripheral joint involvement. This effect is more pronounced in treatment of the peripheral arthritis in this subgroup of AS patients.