Dr. Behrens has received speaking fees (less than $10,000) from Sanofi-Aventis.
Leflunomide in psoriatic arthritis: Results from a large European prospective observational study
Version of Record online: 26 FEB 2013
Copyright © 2013 by the American College of Rheumatology
Arthritis Care & Research
Volume 65, Issue 3, pages 464–470, March 2013
How to Cite
Behrens, F., Finkenwirth, C., Pavelka, K., S̆tolfa, J., S̆ipek-Dolnicar, A., Thaçi, D. and Burkhardt, H. (2013), Leflunomide in psoriatic arthritis: Results from a large European prospective observational study. Arthritis Care Res, 65: 464–470. doi: 10.1002/acr.21848
- Issue online: 21 FEB 2013
- Version of Record online: 26 FEB 2013
- Accepted manuscript online: 6 OCT 2012 10:27AM EST
- Manuscript Accepted: 29 AUG 2012
- Manuscript Received: 20 FEB 2012
To determine the “real-world” clinical effectiveness and safety of leflunomide in patients with psoriatic arthritis (PsA).
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 the Psoriatic Arthritis Response Criteria (PsARC) in patients with pre- and posttreatment data. A modified PsARC response analysis included patients with joint counts, but no severity scores. Other effectiveness evaluations included global assessments, fatigue, pain, skin disease, dactylitis, and nail lesions. All patients were evaluated for safety.
A total of 514 patients were enrolled in this study (mean age 50.7 years, mean disease duration 6.1 years). In the primary effectiveness analysis, 380 (86.4%) of 440 patients (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 drug reactions were serious (2 increased liver enzymes, 1 hypertensive crisis).
Leflunomide is an effective and well-tolerated option for PsA in daily clinical practice, with beneficial effects on peripheral arthritis and on other PsA manifestations, including pain, fatigue, dactylitis, and skin disease.