Six months open label trial of leflunomide in active ankylosing spondylitis.

Abstract

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.

• Authors: H Haibel, M Rudwaleit, J Braun, J Sieper
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 64 Issue 1 Pg. 124-6 (Jan 2005) ISSN: 0003-4967 [Print] England
• PMID: 15608310 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Antirheumatic Agents
• Isoxazoles
• Leflunomide

Topics

• Adult
• Aged
• Anti-Inflammatory Agents, Non-Steroidal (adverse effects, therapeutic use)
• Antirheumatic Agents (adverse effects, therapeutic use)
• Arthritis (drug therapy)
• Arthritis, Psoriatic (drug therapy)
• Female
• Humans
• Isoxazoles (adverse effects, therapeutic use)
• Leflunomide
• Male
• Middle Aged
• Patient Dropouts
• Severity of Illness Index
• Spondylitis, Ankylosing (drug therapy)
• Treatment Outcome