Ann Rheum Dis 64:124-126 doi:10.1136/ard.2003.019174
  • Concise report

Six months open label trial of leflunomide in active ankylosing spondylitis

  1. H Haibel1,
  2. M Rudwaleit1,
  3. J Braun2,
  4. J Sieper1,3
  1. 1Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin Hospital, Berlin, Germany
  2. 2Centre of Rheumatology Ruhrgebiet, Herne, Germany
  3. 3German Rheumatism Research Centre, Berlin, Germany
  1. Correspondence to:
    MsH Haibel
    Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany;
  • Accepted 16 March 2004


Objective: To examine the potential therapeutic effects of leflunomide in patients with active AS in an open label study.

Patients and methods: Twenty patients with AS fulfilling the 1984 modified New York criteria with a Bath AS Disease Activity Index (BASDAI) >3 were given leflunomide for 6 months. Clinical outcome assessments included disease activity (BASDAI), function (BASFI), metrology (BASMI), patient’s and physician’s global assessment, peripheral joint assessment, quality of life (SF-36), global pain, and CRP. Primary end point was a reduction of disease activity as measured by the BASDAI of >25% at 6 months.

Results: A BASDAI 25% improvement was noted in 5/20 (25%) patients and a BASDAI 50% improvement in 4/20 (20%) patients. The absolute BASDAI did not change significantly over the 6 month study (4.9 at baseline v 4.3 at week 24, p>0.05). Similarly, no significant change was found for the BASFI, BASMI, patient’s and physician’s global assessment, SF-36 mental component, and CRP. For the 10 patients with peripheral arthritis, the mean number of inflamed joints was significantly reduced from 1.7 at baseline to 0.9 at week 12 (p = 0.034) and 0.2 at week 24 (p = 0.039).

Conclusion: In this open study of patients with active AS only those with peripheral arthritis improved significantly with leflunomide treatment. Axial symptoms did not improve.


  • The topic of this paper forms part of Dr Haibel’s thesis