Comparison of sulfasalazine and placebo in the treatment of ankylosing spondylitis. A department of veterans affairs cooperative study

Abstract

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 (doubleblind) 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 c 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.Ankylosing spondylitis (AS) is a disease characterized by sacroiliitis and spondylitis commonly involving the lumbar spine and, less commonly, the thoracic and cervical spine. Despite a number of advances in the immunogenetics of AS, the etiology of this disease has not been elucidated. Thus, treatment remains empirical and unsatisfactory. Patient education about the natural history and course of AS is an important adjunct to treatment. Nonsteroidal antiinflammatory drugs (NSAIDs) have been the foundation of medical therapy,

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

“…Patient self-assessment measures included morning stiffness, night pain, patient global assessment, and Spondylitis Functional Index, as described in the article on SSZ in ankylosing spondylitis, which appears elsewhere in this issue of Arthritis and Rheumatism (9).…”

“…A detailed description of the analytic methods appears elsewhere in this issue ofArthritis and Rheumatism (9). Briefly, the change in primary and secondary outcome measures from baseline to the last available followup were analyzed using t-tests for continuous data and chi-square tests for ordinal and categorical data.…”

Extraintestinal Manifestations of Crohn’s Disease

“…At least ten double-blind studies have evaluated the efficacy of sulfasalazine, but none included patients with IBD arthropathies. A meta-analysis of five randomized controlled studies in 1990 concluded that there are some beneficial effects of sulfasalazine therapy [22] in AS, but this was followed by two large multicenter trials showing that efficacy of this treatment was limited to the peripheral joint involvement of the disease [23,24,25]. While less well evaluated, the use of mesalamine is supported by the results of two small studies [21, 26, 27].…”

Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab

“…(UCSF) index 14,15 , and the Berlin index 10 . However, there is no consensus or a clear recommendation regarding which of these enthesitis indices should be used, especially in pSpA 16,17 .…”