Etanercept improves the health-related quality of life of patients with psoriasis: results of a phase III randomized clinical trial

In this randomized, double-blind, phase III trial, patients with psoriasis received etanercept for 24 weeks or placebo for 12 weeks followed by etanercept for 12 weeks. At week 12, improvement in Dermatology Life Quality Index was 47% to 61% with etanercept compared with 11% with placebo (P < .0001). Etanercept rapidly and substantially improved patients' health-related quality of life.     

Cardiovascular safety of ustekinumab in patients with moderate to severe psoriasis: results of integrated analyses of data from phase II and III clinical studies

Background Patients with psoriasis are believed to be at an increased risk of cardiovascular (CV) morbidity, and the effect of biological agents on CV safety is not fully understood. Objectives To evaluate the effect of ustekinumab on CV events using detailed analyses of pooled data from the phase II/III clinical studies of its use in moderate to severe psoriasis. Methods The incidence of major adverse CV events [MACE: myocardial infarction (MI), stroke or CV death] is reported. Meta‐analyses using risk difference and odds ratio estimates are presented based on data collected during the placebo‐controlled period of ustekinumab trials. The cumulative numbers of events and rates of MIs and strokes over time were compared with those expected in the psoriasis and/or general populations. Results During the placebo‐controlled period (12/20 weeks), five MACE were reported in 1582 ustekinumab‐treated patients [0·3%; 95% confidence interval (CI) 0·1–0·7%] compared with no events in 732 placebo‐treated patients (0·0%; 95% CI 0·0–0·5%). MACE rates were stable over time during both the controlled and uncontrolled study periods, with 19 of 3117 ustekinumab‐treated patients (0·6%) experiencing 21 events for a combined event rate per 100 patient‐years of follow‐up of 0·44 (95% CI 0·27–0·67) through up to 3 years. Standardized incidence ratios for comparison of ustekinumab clinical data with external data sources ranged from 0·34 to 0·52, suggesting no increased risk of MI or stroke in ustekinumab‐treated patients compared with the general U.S. and psoriasis populations. Conclusions The totality of available clinical data suggests neither a detrimental nor a beneficial effect of ustekinumab on serious CV events. Additional data are needed to define the net effect of ustekinumab on CV events.     

Comorbidities,metabolic risk profile and health‐related quality of life in German patients with plaque‐type psoriasis: a cross‐sectional prospective study

Background Patients with psoriasis experience a higher risk of cardiovascular and metabolic comorbidities and have a high burden of treatment. There is still a gap between treatment options and quality of care. The purpose of this study was to determine the demographic data, comorbidities, and the limitations of quality of life in patients with plaque‐type psoriasis. Materials and methods This epidemiological evaluation was designed as a single‐center, cross‐sectional, prospective study in Marburg, Germany. To investigate the association between mild to severe psoriasis and comorbidities, data were obtained from 133 patients. Results The average Psoriasis Area and Severity Index was 13.4, and the average Dermatology Life Quality Index was 6.3. Among the patients with severe psoriasis, 95% had been prescribed systemic treatments. Comorbidities were evaluated, with depression 30.8%, arterial hypertension 39.1%, and hypercholesterolemia 20.3% in all patients. Conclusions Our findings underscore the importance of cardiovascular and metabolic risk screening for all patients with psoriasis. There is still a need for systemic treatments and the definition of treatment goals for psoriasis as a systemic inflammatory disease. Such goals should integrate parameters that include comorbidities and an improvement in health‐related quality of life.     

Comorbidities and health‐related quality of life in Spanish patients with moderate to severe psoriasis: A cross‐sectional study (Arizona study)

Psoriasis is a common, chronic inflammatory immunologically mediated disease of the skin, showing a high prevalence of associated comorbidities, and strongly affecting patients' health‐related quality of life (HR‐QOL), with profound impact on the psychological aspect. We aimed to establish the correlation between HR‐QOL and the associated comorbidities in patients with moderate to severe psoriasis in Spain. A cross‐sectional, observational, epidemiological study was conducted at 68 dermatology‐based centers across Spain. From October 2010 to June 2011, all adult patients diagnosed with moderate to severe psoriasis at least 6 months prior to the study visit and receiving or not receiving treatment for psoriasis were eligible for inclusion. A total of 1022 patients were included. The study population showed mean 36‐item short‐form (SF‐36) physical and mental health scores and Dermatological Life Quality Index (DLQI) of 49.7, 46.2 and 5.3, respectively. The multiple linear regression models showed that patients with moderate to severe psoriasis and a diagnosis of psoriatic arthritis (PsA), hypertension, diabetes mellitus, sleep disturbances or obesity were found to have lower SF‐36 health physical scores. Female patients with depression or anxiety disorders had lower SF‐36 health mental scores. Patients diagnosed with moderate to severe psoriatic disease and associated anxiety disorder had greater DLQI scores. Moderate to severe psoriasis has a significant burden on the HR‐QOL of patients. Regardless of sex, patients with several comorbidities such as PsA, hypertension or obesity were found to have worse scores in the physical component of the QOL questionnaire, whilst women were more affected in the mental health component than men.