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Leflunomide in psoriatic arthritis: Results from a large european prospective observational study.
MedLine Citation:
PMID:  23042698     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: To determine the "real-world" clinical effectiveness and safety of leflunomide in patients with psoriatic arthritis (PsA). METHODS: This prospective, multinational 24-week observational study involved adult patients with active PsA who initiated treatment with leflunomide.Patients were evaluated at baseline, 12 weeks, and 24 weeks.The primary outcome was response as assessed by Psoriatic Arthritis Response Criteria (PsARC) in patients with pre- and post-treatment data.A modified PsARC response analysis included patients with joint counts, but no severity scores.Other effectivenessevaluations included global assessments, fatigue, pain, skin disease, dactylitis, and nail lesions.All patients were evaluated for safety. RESULTS: A total of 514 patients were enrolled in this study (mean age, 50.7 years; mean disease duration,6.1 years). In the primary effectivenessanalysis, 380 of 440patients (86.4%; 95% confidence interval 82.8% - 89.4%) achieved a PsARC response at 24 weeks. Significant improvements were observed in tender and swollen joint scores and counts, patient and physician global assessments, fatigue, pain, skin disease, dactylitis, and nail lesions.The discontinuation rate was 12.3%.Ninety-eight adverse drug reactions occurred in 62 (12.1%) patients; 3 were serious (2 increased liver enzymes, 1 hypertensive crisis). CONCLUSION: Leflunomide is an effective and well toleratedoption for PsA in daily clinical practice, with beneficial effects on peripheral arthritis and on other PsA manifestations, including pain, fatigue, dactylitis, and skin disease. © 2012 by the American College of Rheumatology.
Authors:
Frank Behrens; Christoph Finkenwirth; Karel Pavelka; Jiří Stolfa; Alenkašipek- Dolnicar; Diamant Thaçi; Harald Burkhardt
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-6
Journal Detail:
Title:  Arthritis care & research     Volume:  -     ISSN:  2151-4658     ISO Abbreviation:  Arthritis Care Res (Hoboken)     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-8     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101518086     Medline TA:  Arthritis Care Res (Hoboken)     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 by the American College of Rheumatology.
Affiliation:
CIRI/Division of Rheumatology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany. Frank.Behrens@kgu.de.
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