Objectives: To assess the effect of sulfasalazine (SSZ) on inflammatory back pain (IBP) due to active undifferentiated spondyloarthritis (uSpA) or ankylosing spondylitis in patients with symptom duration <5 years.
Methods: Patients with IBP and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >3 from 12 centres were randomly assigned to 24 weeks’ treatment with SSZ 2 g/day or placebo. The primary outcome variable was the change in BASDAI over 6 months. Secondary outcomes included measures of spinal pain, physical function and inflammation.
Results: 230 patients (50% men, age range 18–64 years, 67% human leucocyte antigen B27 positive) were treated with either SSZ 2×1 g/day or placebo for 6 months. Enthesitis was found in 50%, and peripheral arthritis in 47% of the patients. The mean (SD) BASDAI dropped markedly in both groups: by 3.7 (2.7) and 3.8 (2.4), respectively, as did most secondary outcome measures. No noticeable difference in treatment was observed between groups. Patients with IBP and no peripheral arthritis had significantly (p = 0.03) more benefit with SSZ (BASDAI 5.1 (1.3) to 2.8 (2.3)) than with placebo (5.2 (1.6) to 3.8 (2.4)). Spinal pain (p = 0.03) and morning stiffness (p = 0.05) improved with SSZ in these patients, but other secondary outcomes were not markedly different.
Conclusion: SSZ was no better than placebo for the treatment of the signs and symptoms of uSpA; however, SSZ was more effective than placebo in the subgroup of patients with IBP and no peripheral arthritis.
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- BASDAI, Bath Ankylosing Spondylitis Disease Activity Index
- BASFI, Bath Ankylosing Spondylitis Functional Index
- DMARD, disease-modifying antirheumatic drug
- ESR, erythrocyte sedimentation rate
- ESSG, European Spondyloarthropathy Study Group
- HLA, human leucocyte antigen
- IBP, inflammatory back pain
- NSAID, non-steroidal anti-inflammatory drug
- SpA, spondyloarthritis
- SSZ, sulfasalazine
- uSpA, undifferentiated spondyloarthritis
- WOMAC, Western Ontario and MacMaster
Published Online First 10 April 2006
Funding: This study was sponsored by Pfizer GmbH, Karlsruhe, Germany (originally Pharmacia & Upjohn), who provided the study drug and financial support.
Competing interests: None.
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