COMPARISON OF SULFASALAZINE AND PLACEBO IN THE TREATMENT OF ANKYLOSING-SPONDYLITIS - A DEPARTMENT-OF-VETERANS-AFFAIRS COOPERATIVE STUDY

Objective. To determine whether sulfasalazine (SSZ) at a dosage of 2,0 00 mg/day is effective for the treatment of active ankylosing spondyli tis (AS) that is not controlled with nonsteroidal antiinflammatory dru g therapy. Methods. Two hundred sixty-four patients with AS were recru ited from 15 clinics, randomized (double-blind) to SSZ or placebo trea tment, and followed up for 36 weeks. Treatment response was based on m orning stiffness, back pain, and physician and patient global assessme nts. Results. While longitudinal analysis revealed a trend favoring SS Z in the middle of treatment, no difference was seen at the end of tre atment. 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 associ ated peripheral arthritis showed improvement that favored SSZ (P = 0.0 2). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints. Conclusion. SSZ at a dosage o f 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 we ll tolerated and may be more effective than placebo in the treatment o f AS patients with peripheral joint involvement. This effect is more p ronounced in treatment of the peripheral arthritis in this subgroup of AS patients.