Document Detail

Six months open label trial of leflunomide in active ankylosing spondylitis.
MedLine Citation:
PMID:  15608310     Owner:  NLM     Status:  MEDLINE    
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.
H Haibel; M Rudwaleit; J Braun; J Sieper
Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Annals of the rheumatic diseases     Volume:  64     ISSN:  0003-4967     ISO Abbreviation:  Ann. Rheum. Dis.     Publication Date:  2005 Jan 
Date Detail:
Created Date:  2004-12-20     Completed Date:  2005-02-17     Revised Date:  2008-11-20    
Medline Journal Info:
Nlm Unique ID:  0372355     Medline TA:  Ann Rheum Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  124-6     Citation Subset:  IM    
Medical Department I, Rheumatology, Charité, Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany.
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MeSH Terms
Anti-Inflammatory Agents, Non-Steroidal / adverse effects,  therapeutic use*
Antirheumatic Agents / adverse effects,  therapeutic use*
Arthritis / drug therapy
Arthritis, Psoriatic / drug therapy
Isoxazoles / adverse effects,  therapeutic use*
Middle Aged
Patient Dropouts
Severity of Illness Index
Spondylitis, Ankylosing / drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 0/Antirheumatic Agents; 0/Isoxazoles; 75706-12-6/leflunomide

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