Usefulness of the Psoriatic Arthritis Screening and Evaluation Questionnaire to Monitor Disease Activity in Management of Patients with Psoriasis: Findings from the EPI-PSODE Study.

BACKGROUND: Psoriasis and psoriatic arthritis (PsA) are included in the group of immune-mediated inflammatory diseases (IMIDs) caused by systemic inflammation; however, indicators for monitoring inflammatory activity in patients with psoriasis, such as the Psoriasis Area and Severity Index (PASI), are limited. OBJECTIVE: To determine whether the Psoriatic Arthritis Screening and Evaluation (PASE) questionnaire can be used to monitor disease activity in patients with psoriasis. METHODS: This was a multicenter, noninterventional, cross-sectional study. Demographic factors and PASI and PASE scores were collected to investigate associations between each. RESULTS: PASE data were available for 1,255 patients, of whom 498 (39.7%) had a score of ≥37. Compared with the group with PASE score <37, the group with score ≥37 had a higher proportion of women (34.9% vs. 48.8%, p<0.0001), older mean age at diagnosis (36.4 vs. 41.7 years, p<0.0001), more severe disease activity using PASI and body surface area measures (p=0.0021 and p=0.0008, respectively), and higher mean body mass index (23.7 vs. 24.1, p=0.0411). In a multiple linear regression model, PASE score was positively associated with cutaneous disease activity (p<0.0001). CONCLUSION: After risk-adjustment, PASE was positively associated with PASI, which suggests that PASE can be sensitive to disease activity. Since psoriasis is regarded as one of the IMIDs, PASE may be utilized as a tool not only to screen PsA but also to monitor disease activity.

The Clinical Profile of Patients with Psoriasis in Korea: A Nationwide Cross-Sectional Study (EPI-PSODE).

BACKGROUND: Psoriasis is an immune-mediated, chronic inflammatory disease affecting multiple aspects of patients' lives. Its epidemiology varies regionally; however, nationwide epidemiologic data on psoriasis depicting profile of Korean patients has not been available to date. OBJECTIVE: To understand nationwide epidemiologic characteristics and clinical features of adult patients with psoriasis visited university hospitals in Korea. METHODS: This multicenter, non-interventional, cross-sectional study recruited 1,278 adult patients with psoriasis across 25 centers in Korea in 2013. Various clinical data including PASI, BSA, DLQI, SF-36 and PASE were collected. RESULTS: A total of 1,260 patients completed the study (male:female=1.47:1). The mean age was 47.0 years with a distribution mostly in the 50s (24.9%). Early onset (<40 years) of psoriasis accounted for 53.9% of patients. The mean disease duration was 109.2 months; mean body mass index was 23.9 kg/m2; and 12.7% of patients had a family history of psoriasis. Plaque and guttate types of psoriasis accounted for 85.8% and 8.4%, respectively. Patients with PASI ≥10 accounted for 24.9%; patients with body surface area ≥10 were 45.9%. Patients with DLQI ≥6 accounted for 78.8%. Between PASI <10 and PASI ≥10 groups, significant difference was noted in age at diagnosis, disease duration, blood pressure, waist circumference of female, and treatment experiences with phototherapy, systemic agents, and biologics. CONCLUSION: This was the first nationwide epidemiologic study of patients with psoriasis in Korea and provides an overview of the epidemiologic characteristics and clinical profiles of this patient population.

Relation between the Peripherofacial Psoriasis and Scalp Psoriasis.

BACKGROUND: Facial involvement of psoriasis is known to be one of the clinical manifestations that indicate the severity of the psoriasis and thought to be more closely associated with certain distribution. Centrofacial (CF) psoriasis has been suggested to be related with severity of systemic disease while peripherofacial (PF) psoriasis has been thought to have connection with scalp psoriasis. OBJECTIVE: To analyze the epidemiologic characteristics, clinical features and subjective feelings of patients with facial psoriasis and to find out relationship between scalp psoriasis and facial involvement according to the facial types. METHODS: One hundred nineteen facial psoriasis patients were categorized into 3 types according to the distribution: PF type, CF type and mixed facial (MF) type. Onset and duration of facial and scalp psoriasis, and their relationship were questioned. Severity and extent of psoriasis on whole body, face, and scalp were rated by clinicians. RESULTS: There was no significant difference of whole body psoriasis area and severity index (PASI) and body surface area (BSA) score but scalp PASI and BSA was much higher in PF psoriasis compared to CF psoriasis (scalp PASI, 17.9 vs. 10.1; p=0.005) (scalp BSA, 40.9 vs. 22.2; p=0.002). According to the questionnaire, patient's objective feeling about the spreading of scalp lesion to facial area was markedly more prominent in the patients with peripheral involvement (PF+MF, 90.1%; CF, 54.2%; p<0.0001). CONCLUSION: Among subtypes of facial psoriasis, PF psoriasis is closely associated with spreading of scalp lesion into the face rather than reflecting the disease severity.

A multicenter, randomized, open-label pilot trial assessing the efficacy and safety of etanercept 50 mg twice weekly followed by etanercept 25 mg twice weekly, the combination of etanercept 25 mg twice weekly and acitretin, and acitretin alone in patients with moderate to severe psoriasis.

BACKGROUND: Etanercept, a soluble tumor necrosis factor receptor, and acitretin have been shown to be effective in treating psoriasis. Acitretin is widely used in Korea. However, the combination of etanercept plus acitretin has not been evaluated among Korean patients with psoriasis. The objective of this study was to investigate the efficacy and safety of combination therapy with etanercept and acitretin in patients with moderate to severe plaque psoriasis. METHODS: Sixty patients with psoriasis were randomized to receive etanercept 50 mg twice weekly (BIW) for 12 weeks followed by etanercept 25 mg BIW for 12 weeks (ETN-ETN); etanercept 25 mg BIW plus acitretin 10 mg twice daily (BID) for 24 weeks (ETN-ACT); or acitretin 10 mg BID for 24 weeks (ACT). The primary efficacy measurement was the proportion of patients achieving 75 % improvement in Psoriasis Area and Severity Index (PASI 75) at week 24. Secondary end points included 50 % improvement in PASI (PASI 50) at week 24 and clear/almost-clear by Physician Global Assessment (PGA) at each visit through week 24. RESULTS: The proportions of patients achieving PASI 75, PASI 50, and PGA clear/almost-clear at week 24 in the ETN-ETN (52.4, 71.4, and 52.4 %, respectively) and ETN-ACT groups (57.9, 84.2, and 52.6 %, respectively) were higher than in the ACT group (22.2, 44.4, and 16.7 %, respectively). The incidence of adverse events was similar across all arms. This was an open-label study with a small number of patients. CONCLUSION: In Korean patients with moderate to severe plaque psoriasis, etanercept alone or in combination with acitretin was more effective than acitretin. All treatments were well tolerated throughout the study. TRIAL REGISTRATION: This study was registered on July 7, 2009 at ClinicalTrials.gov, NCT00936065 .

Facial Psoriasis Log-based Area and Severity Index: A valid and reliable severity measurement method detecting improvement of facial psoriasis in clinical practice settings.

Facial psoriasis is often observed in moderate to severe degrees of psoriasis. While we previously demonstrated construct validity of the facial Psoriasis Log-based Area and Severity Index (fPLASI) system for the cross-sectional evaluation of facial psoriasis, its reliability and accuracy to detect clinical improvement has not been confirmed yet. The aim of this study is to analyze whether the fPLASI properly represents the range of improvement for facial psoriasis compared with the existing facial Psoriasis Area and Severity Index (fPASI) after receiving systemic treatments in clinical practice settings. The changing severity of facial psoriasis for 118 patients was calculated by the scales of fPASI and fPLASI between two time points after systemic treatments. Then, percentage changes (ΔfPASI and ΔfPLASI) were analyzed from the perspective of both the Physician's Global Assessment of effectiveness (PGA) and patients' Subjective Global Assessment (SGA). As a result, the distribution of the fPASI was more heavily clustered around the low score range compared with the fPLASI at both first and second visits. Linear regression analysis between ΔfPASI and ΔfPLASI shows that the correlation coefficient was 0.94, and ΔfPLASI represented greater percentage changes than ΔfPASI. Remarkably, degrees of clinical improvement measured by the PGA matched better with ΔfPLASI, while ΔfPASI underestimated clinical improvements compared with ΔfPLASI from treatment-responding groups by the PGA and SGA. In conclusion, the fPLASI represented clinical improvement of facial psoriasis with more sensitivity and reliability compared with the fPASI. Therefore, the PLASI system would be a viable severity measurement method for facial psoriasis in clinical practice.

Comparison of Treatment Goals for Moderate-to-Severe Psoriasis between Korean Dermatologists and the European Consensus Report.

BACKGROUND: The development of therapies for psoriasis has led to the need for a new strategy to the treatment of patients with moderate-to-severe psoriasis. New consensus guidelines for psoriasis treatment have been developed in some countries, some of which have introduced treatment goals to determine the timing of therapeutic regimens for psoriasis. OBJECTIVE: To investigate the opinions held by Korean dermatologists who specialize in psoriasis about treatment goals, and to compare these with the European consensus. METHODS: Korean dermatologists who specialize in psoriasis were asked 11 questions about defining the treatment goals for psoriasis. The questionnaire included questions about the factors used to classify the severity of psoriasis, defining the induction and maintenance phases of psoriasis treatment, defining treatment responses during the induction phase, and defining treatment responses during the maintenance phase. RESULTS: The Korean consensus showed responses that were almost similar to the European consensus, even without using the Delphi technique, which uses repeated rounds of questions to reach a consensus. Only one response that related to psoriasis severity in the context of the quality of patients' lives differed from the European consensus. CONCLUSION: The concept of using treatment goals in the treatment of moderate-to-severe psoriasis can be applied to Korean psoriasis patients. Since a tool for assessing the quality of patients' lives is not commonly used in Korea, the development of a simple, rapidly completed, and region-specific health-related quality of life assessment tool would enable treatment goals to be used in routine clinical practice.

Remission period in psoriasis after multiple cycles of narrowband ultraviolet B phototherapy.

The aim of this study was to investigate the duration of remission periods in psoriasis after narrowband ultraviolet B (NB-UVB) phototherapy, especially during multiple cycles of treatment. We analyzed 63 patients (101 cases) demonstrating marked improvement after NB-UVB phototherapy. The remission period was defined as the duration of time from the end of phototherapy until treatment using either phototherapy or systemic treatments was required again. It was found that an age of 60 years or older, history of systemic therapy within 6 months and three or more phototherapy cycles were significantly associated with shorter remission periods. Furthermore, multivariate analysis confirmed that three or more phototherapy cycles (odds ratio [OR], 4.0; 95% confidence interval [CI], 1.73-9.33; P = 0.001) and a history of systemic therapy (OR, 2.2; 95% CI, 1.27-3.95; P = 0.005) were independently associated with the shorter remission period. In conclusion, when planning NB-UVB phototherapy for psoriatic patients who have undergone multiple phototherapy cycles, clinicians should consider the possibility of shorter remission periods.

Clinical study on psoriasis patients for past 30 years (1982-2012) in Seoul National University Hospital Psoriasis Clinic.

Psoriasis is a chronic relapsing disorder which shows variable clinical features. The long-term clinical study with many patients is important to elucidate the epidemiologic characteristics and clinical features of psoriasis. The purpose of this study was to analyze the epidemiologic characteristics and clinical features of psoriasis in Korean patients. Epidemiologic and clinic data and assessments for severity of extent and activity of psoriasis were collected from the medical records of 5084 patients, who had been newly diagnosed with psoriasis in the Psoriasis Clinic of Seoul National University Hospital between 1982 and 2012. The sex ratio of the psoriasis patients was 1.2:1 (male 54.6%, female 45.4%). The peak age of onset in males was 20s, while it was the teenage years in females. A total of 63.5% of patients developed psoriasis before 30 years of age. Family history of psoriasis was observed in 26.0% of patients. Moderate to severe extent of involvement were more frequently observed in male patients and patients under 30 years of onset age than in females and patients 30 years or over of onset age, respectively. Moderate to severe disease activity were also more frequently presented in male patients, but not in patients under 30 years of onset age. The most common morphological type was nummular (56.7%), followed by large plaque (28.5%) and guttate (8.5%). Nail involvement accompanied in 26.4% of patients. We demonstrated the epidemiologic and clinical characteristics of psoriasis in Korean patients.

Objective measurements of erythema, elasticity and scale could overcome the inter- and intra-observer variations of subjective evaluations for psoriasis severity.

BACKGROUND: Most conventional subjective assessments for psoriasis have inevitable inter- and intra-observer variations. OBJECTIVE: We investigated the objective bioengineering parameters of color and mechanical properties which are possible substitutes of the erythema, scale, and thickness scores of psoriatic plaque. METHODS: Age, gender, and Psoriasis Severity Index (PSI) were noted. In addition, bioengineering parameters of color, mechanical properties, and scale were obtained. RESULTS: The most prominently correlated bioengineering parameters were hue (tan(-1) b*/a*), desquamation index (DI), and elasticity (R7) for PSI erythema, scale, and thickness, respectively. These parameters not only showed significant differences between lesion and control groups but also changed according to psoriasis severity scores. We also showed that brighter, scaly lesions had lower elasticity while the more erythemic lesions corresponded to a more fluid-like state. CONCLUSION: We found that three bioengineering parameters are potential candidates for an objective Psoriasis Severity Index (oPSI).

Ustekinumab improves health-related quality of life in Korean and Taiwanese patients with moderate to severe psoriasis: results from the PEARL trial.

BACKGROUND: The PEARL study showed that the proportion of psoriasis patients achieving the primary endpoint (at least 75% improvement from baseline to week 12 in the Psoriasis Area and Severity Index) was significantly higher in ustekinumab-treated patients compared with placebo. There is a paucity of data regarding the impact of psoriasis and its treatment on health-related quality of life (HRQoL) in Asian patients. OBJECTIVES: To evaluate the effect of ustekinumab on HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis enrolled in the phase III, randomized, double-blind, placebo-controlled PEARL study. METHODS: In the PEARL study, 121 patients were randomized to receive ustekinumab 45 mg at weeks 0, 4, and 16 (n=61) or placebo at weeks 0 and 4 with crossover to ustekinumab at weeks 12 and 16 (n=60). A major secondary endpoint was the change in Dermatology Life Quality Index (DLQI) from baseline at week 12. Other endpoints included the change in individual DLQI domains, proportion of patients achieving DLQI ≤ 1 (no negative effect), and proportion of patients achieving ≥ 5-point reduction in DLQI (clinically meaningful improvement) at week 12. RESULTS: At baseline, psoriasis had a very large effect on HRQoL (average DLQI, 15.7). At week 12, patients treated with ustekinumab 45 mg had significantly greater improvement from baseline in DLQI scores compared with placebo (mean decrease, 11.2 vs 0.5 (P<0.001). Likewise, 32.2% and 1.7% of patients receiving ustekinumab 45 mg and placebo, respectively, achieved a DLQI ≤ 1, and 81.4% and 18.3% achieved ≥ 5-point reduction (both P<0.001 vs placebo). Individual DLQI domains in the ustekinumab group were significantly improved compared with placebo (P<0.001). For ustekinumab-randomized patients, HRQoL improvements were sustained through week 28. Placebo patients who crossed over to ustekinumab experienced similar improvements compared with those randomized to ustekinumab. CONCLUSIONS: Ustekinumab significantly improves HRQoL in Korean/Taiwanese patients with moderate to severe psoriasis.

Epidemiology and clinical features of pediatric psoriasis in tertiary referral psoriasis clinic.

Few epidemiological studies of pediatric patients with moderate to severe psoriasis have been available despite there being no approved systemic therapy for these patients. The aim of the present study was to elucidate clinical features of pediatric psoriasis in a tertiary referral psoriasis clinic. We analyzed the clinical data of 358 patients under 18 years of age referred to our clinic from other private clinics and medical centers. Our data showed a male :female ratio of 1.06:1 and a peak age of onset of 10-11 years. Of the patients, 32.4% had a positive family history. The most prevalent phenotype was plaque type (67.3%) and the mean Psoriasis Area and Severity Index score was 17.2 ± 12.7. The most frequently affected body part was the trunk (69.5%), followed by the legs (65.3%). Exposure to sunlight and summer season improved psoriatic lesions, while stress and winter season aggravated the clinical course. Only 26.0% of patients received systemic therapy or phototherapy during the therapeutic course. Oral acitretin (11.2%) was most frequently used followed by ultraviolet B phototherapy (7.3%). The childhood group (<13 years) showed higher prevalence of guttate and generalized pustular phenotypes and more severe clinical course compared with the adolescent group (13-18 years). In conclusion, our patients showed distinctive features in clinical phenotypes, disease severity and affected body parts compared with previous reports. We also found that clinical application of systemic therapies were limited considering the severe disease state of our patients, demanding a need for more research on treatment of pediatric psoriasis.

Clinical study of psoriasis occurring over the age of 60 years: is elderly-onset psoriasis a distinct subtype?

BACKGROUND: Previous studies demonstrated clinical differences of early- and late-onset psoriasis. However, epidemiological data and clinical characteristics of psoriasis occurring in geriatric patients have been rarely studied. OBJECTIVE: Assessment of epidemiology and clinical features of psoriasis first occurring over the age of 60 years, so-called elderly-onset psoriasis, based on clinical data. MATERIALS AND METHODS: Among 4049 patients visiting our psoriasis clinic for the last 27 years, patients were first divided into early- (onset age before 30 years) and late-onset psoriasis (onset age after 30 years) based on our previous studies. Then, patients of late-onset psoriasis were further divided into middle age-onset group (onset age between 30 and 60 years) and elderly-onset group (onset age over 60 years). Clinical characteristics of elderly-onset psoriasis were compared with early- and middle age-onset groups. We acquired the data both by physician's assessments and patients' responses. RESULTS: Elderly-onset patients comprised 3.2% of total patients, 129 out of 4049. They have shown a lower incidence of family history (P < 0.05). The severity assessed by PASI score, body surface extent, and activity of individual lesions demonstrated that psoriasis of the elderly-onset group was generally milder compared with early- and middle age-onset groups (P < 0.05). In clinical phenotypes, the proportion of guttate type and generalized pustular psoriasis type decreased remarkably, while that of erythroderma type increased (P < 0.05). There was a significant change in the body part of origin comparing early- and middle age-onset groups (P < 0.05). The proportion of scalp increased, while that of knee-elbow and trunk decreased significantly (P < 0.05). Patients' subjective sensation of disease course improved statistically comparing early- and middle age-onset groups (P < 0.05). There was no significant change in the degree of pruritus on psoriatic lesions and nail involvement (P > 0.05). CONCLUSION: The elderly-onset group demonstrated milder disease courses and some changes in clinical phenotypes and body part of origin compared with early- and middle age-onset groups. Therefore, it seems that patients whose onset of psoriasis was over the age of 60 years might have distinct clinical features in some clinical aspects.

Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL).

BACKGROUND: Ustekinumab has been evaluated in Caucasian patients with psoriasis, but no studies have been conducted in Asian patients. OBJECTIVE: To assess the efficacy and safety of ustekinumab in Taiwanese and Korean patients with moderate-to-severe psoriasis. METHODS: In this 36-week, multicenter, double-blind, placebo-controlled study, 121 patients with moderate-to-severe psoriasis were randomized (1:1) to receive subcutaneous injections of ustekinumab 45mg at weeks 0, 4, 16 or placebo at weeks 0, 4 and ustekinumab 45mg at weeks 12, 16. Efficacy endpoints at week 12 included the proportion of patients achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI 75; primary endpoint), proportion of patients with Physician's Global Assessment (PGA) of cleared or minimal, and change from baseline in Dermatology Life Quality Index (DLQI). RESULTS: At week 12, the proportion of patients achieving PASI 75 was 67.2% and 5.0% in the ustekinumab 45mg and placebo groups, respectively (p<0.001). PGA of cleared or minimal was achieved by 70.5% (ustekinumab) and 8.3% (placebo; p<0.001), and median DLQI changes were -11.0 and 0.0, respectively (p<0.001). Efficacy was maintained through week 28 in ustekinumab-treated patients. Adverse event (AE) profiles at week 12 were similar between the ustekinumab and placebo groups: 65.6% and 70.0%, respectively, had at least one reported AE. Through week 36, no disproportionate increase in AEs was observed, with the exception of abnormal hepatic function, which was related to concomitant isoniazid treatment for latent tuberculosis. Injection-site reactions were rare and mild. No deaths, malignancies, or cardiovascular events were reported. CONCLUSIONS: Treatment with subcutaneous ustekinumab 45mg offers a favorable benefit/risk profile for Taiwanese and Korean patients with moderate-to-severe psoriasis. The efficacy and safety profile is consistent with the global phase III studies of ustekinumab in psoriasis.