Leflunomide in psoriatic arthritis: results from a large European prospective observational study.

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 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. 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 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). CONCLUSION: 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.

Incidence of scleroderma spectrum disorders in Slovenia.

OBJECTIVES: This paper aims to investigate the incidence of scleroderma spectrum disorders (SDS) in Slovenia. METHODS: From 01.01.2007 to 31.12.2009 we prospectively examined all patients over 18 years of age suspected of suffering from SDS who were referred to our department, which is the only Rheumatology referral centre in the Ljubljana region serving a population of 518.921 Caucasians over 18. Patient work-up consisted of clinical assessment, laboratory and imaging studies, and functional tests. The working classification of SDS proposed by Maricq and Valter was used to classify patients as having CREST syndrome, digital scleroderma disease (SD), intermediate SD, diffuse SD, undifferentiated connective tissue disease with SD features, and SD sine scleroderma. Patients with certain features of SDS who did not fit any specific class were classified as having prescleroderma using LeRoy's classification of early systemic sclerosis. RESULTS: We examined 100 patients. Forty-one new cases of SDS were diagnosed (37 females, 4 males), aged 58.9±15.1 years (24-86 years). CONCLUSIONS: The overall age-adjusted annual incidence of SDS in Slovenia is 2.6 per 100.000 adults per year (95%CI=1.7-3.5).