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Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial
  1. J Braun1,
  2. J Zochling1,
  3. X Baraliakos1,
  4. R Alten2,
  5. G Burmester3,
  6. K Grasedyck4,
  7. J Brandt5,
  8. H Haibel6,
  9. M Hammer7,
  10. A Krause8,
  11. F Mielke9,
  12. H-P Tony10,
  13. W Ebner11,
  14. B Gömör12,
  15. J Hermann13,
  16. H Zeidler14,
  17. E Beck15,
  18. M Baumgaertner16,
  19. J Sieper6
  1. 1Rheumazentrum-Ruhrgebiet, Herne, Germany
  2. 2Schlossparkklinik, Berlin, Germany
  3. 3Charité, Campus Mitte, Berlin
  4. 4University Hospital Eppendorf, Hamburg, Germany
  5. 5Rheumatologische Gemeinschaftspraxis, Berlin-Steglitz, Germany
  6. 6Charité, Campus Benjamin Franklin, Berlin
  7. 7Rheumatology Department, St Josef’s Stift Sendenhorst, Senderhorst, Germany
  8. 8Immanuel Hospital, Berlin
  9. 9Rheumatology Praxis, Berlin
  10. 10University of Würzburg, Würzburg, Germany
  11. 11Second Department of Internal Medicine, Lainz Hospital, Vienna, Austria
  12. 12Polyclinic of the Hospitaller Brothers of St John of God, Budapest, Hungary
  13. 13Division of Rheumatology, Department of Internal Medicine, Medical University Graz, Graz, Austria
  14. 14Rheumatology Department, University of Hannover, Hannover, Germany
  15. 15Anfomed GmbH, Erlangen, Germany
  16. 16Pfizer GmbH, Karlsruhe, Germany
  1. Correspondence to:
    J Braun
    Rheumazentrum-Ruhrgebiet, Landgrafenstrasse 15, 44652 Herne, Germany; J.Braun{at}


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.

  • 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

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  • 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.