Background: Newer therapies provide high levels of skin clearance in patients with moderate to severe psoriasis. However, insufficient evidence exists on the impact of total skin clearance from the patient's perspective. Objectives: To examine effects of total skin clearance on health-related quality of life (HRQoL) and psoriasis symptom severity in subjects with moderate to severe psoriasis. Methods: Pooled data from a phase 2 dose-ranging trial in psoriasis using brodalumab (antibody to interleukin-17 receptor A) were used to compare subjects with static physician global assessment (sPGA) 1 versus sPGA 0 and subjects with Psoriasis Area and Severity Index (PASI) 75 to 5100 versus PASI 100 at week 12 based on no impairment in Dermatology Life Quality Index (DLQI ¼ 0) and no psoriasis symptoms (Psoriasis Symptom Inventory ¼ 0). Results: Of subjects with sPGA 0 (clear) and 1 (almost clear), 61.4% and 45.7% had a DLQI ¼ 0 (p ¼ 0.15), and 65.5% and 32.6% had a Psoriasis Symptom Inventory ¼ 0 (p ¼ 0.001), respectively. Significantly more subjects with sPGA 1 continued to report itching, redness, scaling, and flaking compared to subjects with sPGA 0. Similar results were observed based on PASI score. Conclusions: A higher proportion of subjects with total skin clearance reported no impairment in HRQoL and no psoriasis symptoms than those who were almost clear.

The PSI is a short, low burden, patient-reported measure of psoriasis symptom severity with documented evidence of content validity.

Currently available chronic HF PRO measures do not fulfill all the recommendations provided in the FDA PRO guidance and therefore may not support an FDA-approved product label claim. Future investigations are merited to develop a PRO measure for use in patients with chronic HF in accordance with the FDA guidance.

BackgroundIn the UK, referrals to specialists are initiated by general practitioners (GPs). Study objectives were to estimate the incidence of diagnosed psoriasis in the UK and identify factors associated with GP referrals to dermatologists.MethodsNewly diagnosed patients with psoriasis were identified in The Health Improvement Network (THIN) database between 01 July 2007-31 Oct 2009. Incidence of diagnosed psoriasis was calculated using the number of new psoriasis patients in 2008 and the mid-year total patient count for THIN in 2008. A nested case–control design and conditional logistic regression were used to identify factors associated with referral.ResultsIncidence rate of diagnosed adult psoriasis in 2008 was 28/10,000 person-years. Referral rate to dermatologists was 18.1 (17.3-18.9) per 100 person-years. In the referred cohort (N=1,950), 61% were referred within 30 days of diagnosis and their median time to referral was 0 days from diagnosis. For those referred after 30 days (39%, median time to referral: 5.6 months), an increase in the number of GP visits prior to referral increased the likelihood of referral (OR=1.87 95% CI:1.73-2.01). A prescription of topical agents such as vitamin D3 analogues 30 days before referral increased the likelihood of being referred (OR=4.67 95% CI: 2.78-7.84), as did corticosteroids (OR=2.45 95% CI: 1.45-4.07) and tar products (OR=1.95 95% CI: 1.02-3.75).ConclusionsEstimates of the incidence of diagnosed adult psoriasis, referral rates to dermatologists, and characteristics of referred patients may assist in understanding the burden on the UK healthcare system and managing this population in primary and secondary care.

BackgroundPsoriasis symptoms have a significant negative impact on health-related quality of life, impairing physical functioning and well-being.ObjectiveTo evaluate the impact of brodalumab, a human anti-interleukin-17R monoclonal antibody, on psoriasis symptom severity as measured by a novel patient-reported outcome measure, the Psoriasis Symptom Inventory, and dermatology-specific health-related quality of life as measured by the Dermatology Life Quality Index (DLQI).MethodsThis was a secondary analysis of a phase II, randomized, double-blind, placebo-controlled clinical study of patients with moderate-to-severe psoriasis (n = 198) treated with brodalumab or placebo. This analysis assessed Psoriasis Symptom Inventory scores and DLQI scores over time. Analyses were conducted on all patients who were randomized and received one or more injections of the study drug according to intention to treat using last observation carried forward to impute missing data.ResultsAt week 12, subjects in the brodalumab groups had significant improvements in mean Psoriasis Symptom Inventory total scores [8·5 (70 mg), 15·8 (140 mg), 16·2 (210 mg) and 12·7 (280 mg)] compared with placebo (4·8). Mean improvements in DLQI were clinically meaningful (≥ 5·7) in the brodalumab groups (6·2, 9·1, 9·6 and 7·1, respectively) and significantly greater than placebo (3·1). Improvements in Psoriasis Symptom Inventory were observed as early as week 2 and in DLQI by week 4. All eight Psoriasis Symptom Inventory item scores improved significantly among the brodalumab groups by week 12.ConclusionsResults were from a single randomized clinical trial and may not generalize to broader patient populations. However, treatment with brodalumab provided significant improvement in psoriasis symptoms in patients with moderate-to-severe psoriasis.

The PSI is a short and valid unidimensional measure of psoriasis symptom severity that is well suited for use in clinical trials.

Introduction: The Psoriasis Symptom Inventory is a patient-reported outcome instrument that assesses severity of psoriasis signs and symptoms. In early qualitative research, patients reported pain related to psoriasis skin lesions and redness of affected areas of skin as key symptoms. Methods: Individual concept elicitation interviews and cognitive interviews were conducted in adults with moderate to severe plaque psoriasis. Interviews were audio-recorded and transcribed. Concepts were identified, coded and grouped by similar content using Atlas.ti software. Results were evaluated using qualitative research methods. Results: Of 30 patients recruited, 20 patients participated in concept elicitation interviews and 10 participated in cognitive interviews. Concept codes for skin pain and descriptions of color comprised 11% and 15%, respectively, of all symptom-related expressions. Of 90 pain-related expressions, 22 were about pain related to unconscious scratching and 68 were about pain from the psoriasis lesions. Of 199 color-related expressions, 72 were about red or reddish lesion color. Patients with darker skin tones were found to interpret redness consistently. Discussion: These results provide further support to content validity of pain and redness concepts in the Psoriasis Symptom Inventory. Conclusions: Symptoms of skin pain and redness are highly relevant to patients with psoriasis.

A large proportion (36%) of patients changed or discontinued biologic therapy within the first year. These patients experienced limited PASI response, if any, suggesting an unmet need for this population.