International multicenter psoriasis and psoriatic arthritis reliability trial for the assessment of skin,joints, nails,and dactylitis

Objective

Clinical trials in psoriasis and psoriatic arthritis (PsA) involve assessment of the skin and joints. This study aimed to determine whether assessment of the skin and joints in patients with PsA by rheumatologists and dermatologists is reproducible.

Methods

Ten rheumatologists and 9 dermatologists from 7 countries met for a combined physical examination exercise to assess 20 PsA patients (11 men, mean age 51 years, mean PsA duration 11 years). Each physician assessed 10 patients according to a modified Latin square design that enabled the assessment of patient, assessor, and order effect. Tender joint count (TJC), swollen joint count (SJC), dactylitis, physician's global assessment (PGA) of PsA disease activity (PGA‐PsA), psoriasis body surface area (BSA), Psoriasis Area and Severity Index (PASI), Lattice System Physician's Global Assessment of psoriasis (LS‐PGA), National Psoriasis Foundation Psoriasis Score (NPF‐PS), modified Nail Psoriasis Severity Index (mNAPSI), number of fingernails with nail changes (NN), and PGA of psoriasis activity (PGA‐Ps) were assessed. Variance components analyses were carried out to estimate the intraclass correlation coefficient (ICC), adjusted for the order of measurements.

Results

There is excellent agreement (ICC ≥0.80) on the mNAPSI, substantial agreement (0.6 ≥ ICC < 0.80) on the TJC, PASI, and NN, moderate agreement (0.4 ≥ ICC < 0.60) on the PGA‐Ps, LS‐PGA, NPF‐PS, and BSA, and fair agreement (0.2 ≥ ICC < 0.40) on the SJC, dactylitis, and PGA‐PsA. The only measure that showed a significant difference between dermatologists and rheumatologists was dactylitis (P = 0.0005).

Conclusion

There is substantial to excellent agreement on the TJC, PASI, NN, and mNAPSI among rheumatologists and dermatologists.     

International spondyloarthritis interobserver reliability exercise--the INSPIRE study: II. Assessment of peripheral joints, enthesitis, and dactylitis

OBJECTIVE: To determine whether the assessments of peripheral joints and enthesitis were reproducible for both AS and PsA with axial disease, and whether dactylitis assessment is reproducible in patients with PsA. METHODS: A group of 20 rheumatologists from 11 countries with expertise in spondyloarthritis (SpA) met for a combined physical examination exercise to assess 10 patients with PsA with axial involvement (9 men, 1 woman, mean age 52 yrs, disease duration 17 yrs) and 9 patients with AS (7 men, 2 women, mean age 38 yrs, disease duration 16 yrs). A modified Latin-square design that enabled assessment of patient, assessor, and order effect was used. Measures included were number of tender and swollen joints, presence of enthesitis using 6 different indices, and dactylitis score. Data were analyzed using intraclass correlation (ICC) adjusted for order of measurements. RESULTS: The majority of the variance was contributed by the patients. There was no order effect. The assessment of tender joints (ICC 0.69) was more reliable than the assessment of swollen joints (ICC 0.54). Moreover, there was better agreement in patients with PsA (ICC 0.78) than in patients with AS (ICC 0.62). There was excellent agreement on the number of active enthesitis sites (ICC 0.86). All the enthesitis indices provided substantial to excellent agreement among observers. Agreement for the dactylitis score was substantial (ICC 0.70). CONCLUSION: The assessment of peripheral joints is more reliable in patients with PsA. Enthesitis instruments can be used reliably in patients with AS and patients with PsA with spinal involvement. The Leeds dactylitis instrument functions well in PsA.     

Atherosclerotic vascular events in a single large lupus cohort: prevalence and risk factors

OBJECTIVE: To determine prevalence and type of atherosclerotic vascular events (AVE) occurring after entry to the University of Toronto Lupus Clinic; and to compare risk factors in patients with systemic lupus erythematosus (SLE) with AVE to matched SLE controls without AVE. METHODS: Patients with SLE attending the University of Toronto Lupus Clinic who did not have AVE prior to clinic entry were included. Patients have been followed at 2-6 months since 1970 according to a standard protocol. Cases with AVE were matched for sex, era at first clinic visit (1970s, 1980s, 1990s +), inception status, age at first visit, and duration of followup. Chi-square, Fisher's exact, paired T test, and McNemar test were used. Comparison of risk factors for the development of AVE was done using a stepwise conditional logistic regression model for matched pairs. RESULTS: In a total cohort of 1087 SLE patients followed from 1970 until 2004, the prevalence of AVE was 10.9%, and in 561 inception patients it was 9.6%. In multivariate analyses, neuropsychiatric involvement was significantly associated with AVE in both the total and inception cohorts. Smoking was also associated with AVE in the inception cohort, whereas the number of coronary artery disease (CAD) risk factors and vasculitis were significant in the total cohort. CONCLUSION: AVE are major contributors to the clinical presentation of late-stage lupus. A combination of lupus related factors and classic CAD risk factors contributed to the development of AVE.     

Clinical manifestations and coronary artery disease risk factors at diagnosis of systemic lupus erythematosus: data from an international inception cohort

Systemic Lupus International Collaborating Clinics (SLICC) comprises 27 centres from 11 countries. An inception cohort of 918 SLE patients has been assembled according to a standardized protocol between 2000 and 2006. Clinical features, classic coronary artery disease (CAD) risk factors, as well as other potential risk factors were collected. Of the 918 patients 89% were females, and of multi racial origin. Less than half the patients were living in a permanent relationship, 58% had post secondary education and 51% were employed. Eight percent had family history of SLE. At enrolment, with at mean age of diagnosis of 34.5 years, a significant number of patients already had CAD risk factors, such as hypertension (33%) and hypercholesterolemia (36%). Only 15% of the patients were postmenopausal, 16% were current smokers and 3.6% had diabetes at entry to the SLICC-RAS (Registry for Atherosclerosis). A number of patients in this multi-racial, multi-ethnic inception cohort of lupus patients have classic CAD risk factors within a mean of 5.4 months from diagnosis. This cohort will be increased to 1500 patients to be followed yearly for 10 years. This will provide a unique opportunity to evaluate risk factors for accelerated atherosclerosis in SLE.     

Biologic therapy of psoriatic arthritis

Psoriatic arthritis is now recognized as a potentially serious and disabling disease. Traditional therapies have not been very effective in controlling signs and symptoms or preventing progression of damage. Based on the pathogenesis of the disease new therapies have been introduced, particularly anti-TNF agents and anti-T cell agents. Several of those have shown excellent responses in clinical variables, health related quality of life and function, and in preventing radiological progression. However, not all patients have responded, and the long-term safety of these drugs remains unknown.     

Effect of infliximab therapy on employment, time lost from work, and productivity in patients with psoriatic arthritis

OBJECTIVE: To examine the effect of infliximab on employment status, time lost from work, and productivity in a double-blind, placebo-controlled study of patients with active psoriatic arthritis (PsA). METHODS: Two hundred adult patients with PsA were randomized to intravenous infusions of either infliximab 5 mg/kg or placebo at Weeks 0, 2, 6, 14, and 22, with early escape at Week 16. Employment status, workdays missed, and productivity were assessed at baseline and at Week 14. The effect of PsA on daily productivity was assessed using a visual analog scale. RESULTS: At baseline, similar percentages of patients in both treatment groups were employed and similar percentages missed workdays; the mean productivity score at baseline was similar between groups (roughly 3 on a scale of 0 to 10). At Week 14, median productivity increased significantly in the infliximab group compared with the placebo group (67.5% vs 9.2%; p < 0.0001). Compared with the placebo group, higher proportions of patients in the infliximab group improved employment status from unemployed at baseline to employed at Week 14 (11.5% vs 0%; p = 0.084) and from part-time to full-time employment (30.0% vs 10.0%; p = 0.582). Among patients employed at baseline and Week 14, a lower proportion of patients in the infliximab group than in the placebo group had missed workdays in the 4 weeks prior to Week 14 (p = 0.138). CONCLUSION: After 14 weeks of treatment, infliximab improved productivity in patients with active PsA. There was also a trend toward increased employment and reduced time lost from work for patients treated with infliximab.