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.

journal_name

Ann Rheum Dis

authors

Haibel H,Rudwaleit M,Braun J,Sieper J

doi

10.1136/ard.2003.019174

subject

Has Abstract

pub_date

2005-01-01 00:00:00

pages

124-6

issue

1

eissn

0003-4967

issn

1468-2060

pii

64/1/124

journal_volume

64

pub_type

临床试验,杂志文章
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    更新日期:1980-06-01 00:00:00

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