Assessment Of Psoriasis Severity Research Articles

Frequency and predictors of a high clinical response in patients with psoriasis on biological therapy in daily practice: results from the prospective, multicenter BioCAPTURE cohort.

It is important to assess which patients with psoriasis are more likely to achieve high clinical responses on biologics. To assess the number of treatment episodes (TEs) that achieve a 100% improvement in Psoriasis Area and Severity Index (PASI 100), PASI 90 or PASI ≤ 5 at week 24 of biological treatment, and which baseline patient characteristics predict treatment response. Data from patients with psoriasis treated with adalimumab, etanercept, infliximab or ustekinumab were extracted from a prospective cohort. TEs with high clinical responses were described. Uni- and multivariate regression analyses were performed with the generalized estimating equation method to elucidate which baseline patient characteristics were predictors for PASI 90 and PASI ≤ 5 at week 24. In total, 454 TEs were extracted (159 adalimumab; 193 etanercept; 19 infliximab; 83 ustekinumab) from 326 patients. At week 24, in 3%, 15% and 59% of TEs, respectively, PASI 100, PASI 90 and PASI ≤ 5 was reached. In TEs without a PASI 100 or PASI 90 response, PASI ≤ 5 was still achieved in 58% and 52%, respectively. Baseline PASI ≥ 10 was a strong predictor for achieving PASI 90; baseline PASI < 10 and a lower baseline body mass index (BMI) were significant predictors for PASI ≤ 5 at week 24. A limited number of patients achieved PASI 100 or PASI 90 at 24 weeks of biological treatment. Including an absolute PASI score in the assessment of psoriasis severity is important. Baseline BMI was an important, modifiable predictor for a high response.

PASI (Psoriasis Area and Severity Index) in the evaluation of the clinical manifestations of psoriasis

Psoriasis is one of the most prevalent chronic inflammatory skin diseases. The severity of its clinical manifestations can vary greatly. Objective assessment of psoriasis severity is required to select an adequate therapy. One of the simplest and most consistent methods used to determine psoriasis severity is to calculate the PASI (Psoriasis Area and Severity Index). This index is based on the doctor’s determination of the sum of indices showing the intensity of the main symptoms of psoriasis: erythema, infiltration and peeling in view of the affected skin area. The PASI can also be used to assess the efficacy of treatment for psoriasis patients.

Plasma total antioxidant capacity and peroxidation biomarkers in psoriasis.

Systemic biomarkers of oxidative stress can be relevant for assessment of psoriasis severity, for prediction of the outcome of therapy and of the development of comorbidities. In this review we aimed to evaluate the relationship between plasma total antioxidant capacity (TAC) and peroxidation biomarkers, as well as their association with dyslipidemia and systemic inflammation in psoriasis. The review of 59 case–control comparisons (from 41 studies) and 17 interventions (from 13 studies) suggests that peroxidation markers are more sensitive than TAC in the evaluation of oxidative stress in psoriasis. Although few studies investigated the effect of treatment on oxidative stress, it seems that biological drugs could be the better choice in the treatment of psoriasis. However, considering the limitations of TAC and plasma peroxidation markers, this review suggests that new methods should be developed in order to evaluate systemic oxidative stress in psoriasis.

Article Commentary: Clinical Severity Measures for Psoriasis: A Case for the PASI

The Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA) are the most commonly used tools for the evaluation of psoriasis disease severity in clinical trials. Based on U.S. Food and Drug Administration requirements, many recent trials concerning measurement of psoriasis disease severity have included the PGA as a primary endpoint alongside the PASI. In this commentary, we review the advantages and disadvantages of the PASI and PGA scales, and discuss an example of a psoriasis patient in whom PGA fails to capture clinically significant disease improvement. We argue that despite its limitations, the PASI is a more accurate and descriptive instrument than the PGA for the assessment of psoriasis severity.

Measurement properties of a patient-reported outcome measure assessing psoriasis severity: The psoriasis symptoms and signs diary

Background: Collecting reliable and valid symptom information from patients is critical for assessing psoriasis severity in clinical research. Objective: To evaluate measurement properties of a new patient-reported outcome (PRO), the Psoriasis Symptoms and Signs Diary (PSSD). Methods: One hundred six US patients with moderate-to-severe plaque psoriasis completed two versions of the PSSD [a 24-hour recall (PSSD-24h) and 7-day recall (PSSD-7d)] using a 0–10 numerical rating scale. Reliability (test-retest and internal consistency), validity (convergent, divergent and known-groups), responsiveness, and version equivalence were evaluated. Minimally important difference was estimated. Results: Based on exploratory factor analysis and clinical input, symptom, sign, and total severity scores were established. Internal consistency (Cronbach’s alpha ≥ 0.944) and test-retest reliability (intraclass correlation coefficients ≥ 0.824) were acceptable. Correlations with Dermatology Life Quality Index (DLQI) (0.489 to 0.644) indicated convergent validity, while low correlations (< 0.30) with several Short Form (SF)-36 scales indicated divergent validity. PSSD scores differed when patients were categorized by Body Surface Area, DLQI, and Psoriasis Area Severity Index scores. PSSD-24h and PSSD-7d versions were equivalent (Pearson correlations ≥ 0.953). Limitations: PSSD responsiveness should be evaluated in patients receiving treatment. Conclusion: The PSSD is reliable and valid in measuring symptoms/signs of patients with moderate-to-severe plaque psoriasis.

The Psoriasis Symptom Inventory: An Effective Patient-reported Outcome Measure of Psoriasis Severity

There is a need for simple, practical, and reliable measurement instruments for use in clinical trials, registries, and clinical practice to assess psoriasis severity and the change in symptoms with treatment. The Psoriasis Area and Severity Index (PASI) is the standard measure of psoriasis used in clinical trials, but it is rarely used in clinical practice and it is not readily used in clinical registries because of its complexity. The Physician Static Global Assessment score is a simpler measure also used in clinical trials and less frequently in registries and practice, but like the PASI, it requires some degree of experience to score. The Psoriasis Symptom Inventory (PSI) was developed as a simple measure to enable patients to self-score psoriasis severity. It has been demonstrated to be reliable and discriminative, and it correlated with the PASI score in a psoriasis clinical trial. It also was recently validated to assess psoriasis in a psoriatic arthritis (PsA) clinical trial. The PSI may be a useful and practical measure of psoriasis severity in psoriasis and PsA clinical trials, registries, and in clinical practice.

Seasonal variation in acne and psoriasis: A three-year study utilizing the Physician’s Global Assessment psoriasis severity scale

Seasonal variation in acne and psoriasis: A three-year study utilizing the Physician’s Global Assessment psoriasis severity scale

Inter-observer reliability of the PASI in a clinical setting.

With the evolving emphasis on evidence-based practice, the use of reliable clinical scales forms an important foundation for clinical assessment. The psoriasis area and severity index (PASI) is the most widely used tool for the measurement of psoriasis severity; however, there has been some debate over the potential reproducibility of PASI scoring. To determine the inter-observer reliability of the PASI at a large tertiary hospital with a psoriasis treatment centre. In total, 34 patients who were due for their 3-monthly follow up at a psoriasis treatment centre were independently evaluated by five clinical staff (observers) from the Department of Dermatology. Each observer independently determined the PASI score of each patient and the inter-observer reliability coefficient was determined by employing intra-class correlation coefficients (ICC). There was a significant degree of concordance among the PASI scoring of observers (ICC = 0.804; CI 95%: 0.706-0.883). Our cross-sectional study suggests that the PASI provides a reproducible method of assessing psoriasis severity among patients seen in a busy dermatology clinic at a large tertiary hospital.

Assessing psoriasis severity and outcomes for clinical trials and routine clinical practice.

Psoriasis is a complex disease. Dermatologists have not documented psoriasis severity, except in clinical trials; doing so requires tools for assessing psoriasis and an understanding of what changes in those assessments mean in terms of outcome. Two psoriasis assessment tools have dominated: The Psoriasis Area and Severity Index and the Dermatology Life Quality Index. There are advantages and disadvantages to each. Newer instruments may not be more suitable for documenting psoriasis. There may be benefits in terms of patient ownership of disease management from using self-assessment tools for documenting severity, for example, the Self-assessment version of the Simplified Psoriasis Index.

Estimation of the serum level of a proliferation-inducing ligand in patients with psoriasis and lichen planus

BackgroundA proliferation-inducing ligand (APRIL) is a new member of the tumor-necrosis factor superfamily. Elevated serum APRIL level has been found in some autoimmune diseases. APRIL costimulates B cells in vitro and in vivo. In addition, APRIL also has an important role in T-cell activation and survival.ObjectiveThe aim of the present study was to determine the serum level of APRIL in patients with psoriasis and lichen planus (LP) to evaluate its role in the pathogenesis of both diseases.Patients and methodsThis study included 40 patients with psoriasis (group II), 40 patients with LP (group III), and 20 healthy individuals who served as controls (group I). Serum samples were taken from all patients and controls for the detection of serum APRIL level by using the enzyme-linked immunosorbent assay.ResultsA significant increase was found in the mean serum APRIL level in patients with psoriasis and LP when compared with controls. Serum APRIL level was significantly correlated with severity of psoriasis, as determined by the psoriasis area and severity index score.ConclusionAPRIL could be implicated as an important cytokine in the pathogenesis of psoriasis and LP. APRIL could be used as a useful marker for assessing psoriasis severity and open the way for further therapeutic approaches for both diseases.

Reduction of Inter-Rater and Intra-Rater Variability in Psoriasis Area and Severity Index Assessment by Photographic Training.

BackgroundSeverity grading is important for the assessment of psoriasis treatment efficacy. This is most commonly achieved by using the psoriasis area and severity index (PASI), a subjective tool with inherent inter-rater and intra-rater variability. PASI-naive dermatologists require training to properly conduct a PASI assessment.ObjectiveIn the present study, we aimed to investigate whether photographic training improves inter-rater and intra-rater variabilities. We also determined which PASI component has the greatest impact on variability.MethodsTwenty-one dermatologists received 1 hour of PASI training. They were tested before and after the training to evaluate intra-rater variability. The physicians were further tested after training by using a reference photograph.ResultsThe mean of each PASI component was underevaluated compared with scoring by a PASI expert. The concordance rate with the expert's grading was highest for thickness followed by erythema, scaling, and area. The scaling score showed the greatest improvement after training. After training, the distribution of deviation from the expert's grading, which signifies inter-rater variability, improved only for the PASI area component. The deviation of scaling grading improved upon retesting by using a reference photograph.ConclusionPASI assessment training improved variabilities to some degree but not for every PASI component. The development of an objective psoriasis severity assessment tool will help overcome the subjective variabilities in PASI assessment, which can never be completely eliminated via training.

One device, one equation: the simplest way to objectively evaluate psoriasis severity.

The erythema, scale and thickness of psoriasis lesions could be converted to bioengineering parameters. An objective psoriasis severity assessment is advantageous in terms of accuracy and reproducibility over conventional severity assessment. We aimed to formulate an objective psoriasis severity index with a single bioengineering device that can possibly substitute the conventional subjective Psoriasis Severity Index. A linear regression analysis was performed to derive the formula with the subjective Psoriasis Severity Index as the dependent variable and various bioengineering parameters determined from 157 psoriasis lesions as independent variables. The construct validity of the objective Psoriasis Severity Index was evaluated with an additional 30 psoriasis lesions through a Pearson correlation analysis. The formula is composed of hue and brightness, which are sufficiently obtainable with a Colorimeter alone. A very strong positive correlation was found between the objective and subjective psoriasis severity indexes. The objective Psoriasis Severity Index is a novel, practical and valid assessment method that can substitute the conventional one. Combined with subjective area assessment, it could further replace the Psoriasis Area and Severity Index which is currently most popular.

Objective measurement of erythema in psoriasis using digital color photography with color calibration.

Traditional metrics for evaluating the severity of psoriasis are highly subjective, which complicates efforts to identify effective treatments in clinical trials. We propose a method for the objective measurement of the psoriasis severity parameter of erythema (redness). This procedure is standardized for different camera systems and lighting environments through the usage of a color card with predetermined color values in order to calibrate the images. Quantitative measures based on the digital color images are shown to correlate well with subjective assessment of psoriasis severity collected using a standard numerical scale by a panel of dermatologists. Additionally, the color calibration process is shown to improve results.

The Brigham Scalp Nail Inverse Palmoplantar Psoriasis Composite Index (B-SNIPI): a novel index to measure all non-plaque psoriasis subsets.

Psoriasis is a chronic inflammatory disease that encompasses a large spectrum of clinically distinct subtypes. Although chronic plaque psoriasis is reported as the most common form of psoriatic skin disease, there is growing evidence that other variants including scalp, nail, inverse, and palmoplantar psoriasis are prevalent, undertreated, and associated with significant impairment in quality of life. Currently, the Psoriasis Area and Severity Index (PASI) is the standard to assess psoriasis severity as well as response to treatment; however, the PASI has several limitations. In response to this need and as a complementary objective measure to the PASI, we created the Brigham Scalp Nail Inverse Palmoplantar Psoriasis Composite Index (B-SNIPI), based on patient-surveyed, patient-reported outcomes equally weighted with physician assessment of disease activity. Herein we summarize the B-SNIPI as presented at the 2013 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

Product of the Physician Global Assessment and body surface area: A simple static measure of psoriasis severity in a longitudinal cohort

The Psoriasis Area and Severity Index (PASI) is considered the gold standard assessment tool for psoriasis severity, but PASI is limited by its complexity and insensitivity in people with mild psoriasis. We sought to evaluate the product of a Physician Global Assessment (PGA) and Body Surface Area (BSA) (PGAxBSA) as an alternative to PASI. Psoriasis severity was evaluated at 6-month intervals in participants of the Utah Psoriasis Initiative registry. Correlation coefficients were used to compare PGAxBSA with PASI and the Simplified PASI (SPASI). Between August 2008 and November 2010, 435 assessments were completed in 226 participants. The median PASI score was 3.2 (interquartile range 1.8-5.4) and the median BSA was 3.0% (interquartile range 1.0%-5.0%). PGAxBSA had higher correlations with PASI than SPASI (0.87 vs 0.76, P<.001). PGAxBSA also had higher correlations with a Global Patient Assessment of psoriasis severity (0.65) than both PASI (0.59, P<.001) and SPASI (0.51, P<.001). The use of PGAxBSA for measuring severe psoriasis and response to therapy is unclear, because most participants had mild to moderate psoriasis and data were not collected at predefined intervals in relation to therapy initiation. Interrater reliability was not assessed. PGAxBSA is a simple and sensitive instrument for measuring psoriasis severity.

Disease quantification in dermatology:in vivonear-infrared spectroscopy measures correlate strongly with the clinical assessment of psoriasis severity

Accurate documentation of disease severity is a prerequisite for clinical research and the practice of evidence-based medicine. The quantification of skin diseases such as psoriasis currently relies heavily on clinical scores. Although these clinical scoring methods are well established and very useful in quantifying disease severity, they require an extensive clinical experience and carry a risk of subjectivity. We explore the opportunity to use in vivo near-infrared (NIR) spectra as an objective and noninvasive method for local disease severity assessment in 31 psoriasis patients in whom selected plaques were scored clinically. A partial least squares (PLS) regression model was used to analyze and predict the severity scores on the NIR spectra of psoriatic and uninvolved skin. The correlation between predicted and clinically assigned scores was R=0.94 (RMSE=0.96), suggesting that in vivo NIR provides accurate clinical quantification of psoriatic plaques. Hence, NIR may be a practical solution to clinical severity assessment of psoriasis, providing a continuous, linear, numerical value of severity.

Treatment goals for moderate to severe psoriasis: An Australian consensus

The high incidence of comorbidities in patients with psoriasis, significant impact on quality of life and patients' dissatisfaction with treatment led a European group to develop a consensus position on psoriasis treatment goals. There is an evident need for similar treatment goals in Australia. The aim of this project was to develop Australian treatment goals that reflect the local environment. A panel of 12 representatives was drawn from across Australia consisting of nine dermatologists and a rheumatologist, a dermatology nurse and a general practitioner (GP)/dermatology trainee. The group met on three occasions between September 2011 and March 2012. The panel undertook a literature review and critically examined available evidence-based treatment goals. A questionnaire relating to psoriasis assessment and specific treatment outcomes was developed. Following discussion and debate, recommended treatment goals for psoriasis patients in Australia were determined. The panel agreed by consensus on recommended psoriasis treatment goals in the Australian environment. There was recognition that in addition to psoriasis area severity index (PASI) assessment, a quality of life assessment was highly relevant in determining psoriasis severity and treatment outcome. Mild psoriasis was defined as PASI ≤ 10 and a dermatology life quality index (DLQI) ≤ 10, with moderate to severe psoriasis defined as PASI > 10 and/or DLQI > 10. The presence of certain definedclinical features would elevate a patient's classification from mild to moderate/severe. The target for treatment was defined as a maintained change in PASI ≥ 75% improvement and DLQI ≤ 5. These largely concurred with the European treatment goals. A flow chart for psoriasis management in Australia based on outcome measures was developed. There is a need to identify and articulate treatment goals for psoriasis. Assessment of psoriasis severity requires both physical scoring (PASI) and consideration of quality of life measures (DLQI). Identification of treatment goals will guide clinicians in treatment decision-making, enhance the availability and appropriate use of therapies and increase patient satisfaction with their care.

Physical and Mental Impact of Psoriasis Severity as Measured by the Compact Short Form-12 Health Survey (SF-12) Quality of Life Tool

The Short Form-12 Health Survey (SF-12) is used to assess the patient's quality of life (QoL) using the physical component score (PCS) and the mental component score (MCS). The purpose of this study was to determine whether the SF-12 PCS and MCS are associated with psoriasis severity and to compare QoL between Murdough Family Center for Psoriasis (MFCP) patients and patients with other major chronic diseases included in the National Survey of Functional Health Status data. We used data from 429 adult patients enrolled in MFCP. Psoriasis Area Severity Index (PASI) was used to assess psoriasis severity at the time of completion of the SF-12 questionnaire. Other variables included age, sex, body mass index, psoriatic arthritis, psychiatric disorders, and comorbidities. Linear regression models were used to estimate effect sizes ± 95% confidence intervals. For every 10-point increase in PASI, there was a 1.1 ± 1.3 unit decrease in MCS (P=0.100) and a 2.4 ± 1.3 unit decrease in PCS (P<0.001). Psoriasis severity was associated with PCS and MCS after adjusting for variables, although the strength of the relationship was attenuated in some models. Psoriasis severity is associated with decreased QoL. SF-12 may be a useful tool for assessing QoL among psoriasis patients.

Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI): Why do both? A systematic analysis of randomized controlled trials of biologic agents for moderate to severe plaque psoriasis

Although there are many psoriasis assessment tools currently published, one of the unmet needs in psoriasis research remains consensus about the single best validated and reproducible assessment tool. In this systematic review we sought to determine the degree of correlation between two commonly used psoriasis assessment tools, the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA). Randomized controlled systemic trials in moderate to severe psoriasis were reviewed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. We recorded and compared the percent of patients achieving both 75% reduction in PASI score (PASI 75) and PGA 0 or 1 (clear or almost clear) at 8 to 16 weeks, 17 to 24 weeks, and greater than 24 weeks of treatment with the investigational drug. Our literature review yielded 30 randomized controlled trials using biologic agents in moderate to severe psoriasis. We found that the two assessment tools correlate very tightly except at the lower bounds of therapeutic efficacy. The r(2) values for the correlation between PASI 75 and a score of clear or almost clear on the PGA were 0.9157 at 8 to 16 weeks and 0.892 at 17 to 24 weeks. Limitations of our study include the small number of randomized controlled trials publishing the percent of patients achieving 75% reduction in PASI score and a score of clear or almost clear on the PGA after 24 weeks of therapy. In addition, our results are not generalizable beyond the patients with moderate to severe plaque psoriasis. The two assessment tools are substantially redundant and either alone is a sufficient tool for assessing psoriasis severity in patients with moderate to severe disease. Because the PASI is better validated and more detailed, it remains the score of choice for clinical trials, but the simpler PGA may be well suited for community-based outcomes projects.

Impact of ustekinumab on health‐related quality of life and sexual difficulties associated with psoriasis: results from two phase III clinical trials

Ustekinumab, a human anti-interleukin-12/23 monoclonal antibody, has been shown to effectively treat moderate-to-severe psoriasis which significantly affects health-related quality of life (HRQoL), including patients' sexual lives. The aim of this study was to determine if sexual difficulties associated with psoriasis are related to disease severity and whether sexual difficulties improve with skin disease during ustekinumab treatment. In phase III PHOENIX 1 and 2 trials, psoriasis patients were randomized to ustekinumab (n=1334) at weeks 0 and 4 and q12 weeks thereafter or placebo (n=662) at weeks 0 and 4 with crossover to ustekinumab at week 12. Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) were used to assess psoriasis severity and patient-reported HRQoL respectively. Based on DLQI Question #9, impaired sexual function was defined as 'very much' or 'a lot' of sexual difficulties. At baseline, mean DLQI was 12.0, indicating a very large negative effect on patients' lives. Impaired sexual function was reported by 22.6% (women=27.1%; men=20.8%) and was significantly associated with increased psoriasis severity. At week 12, ustekinumab-treated patients had a greater mean improvement in DLQI (-9.13 vs. -0.53 with placebo, P<0.001) and the proportion of patients with impaired sexual function decreased from 22.4% to 2.7% compared with no change with placebo (P<0.001). Patients with greater PASI improvement experienced a greater reduction of sexual difficulties due to psoriasis. A similar pattern of improved sexual function was observed at weeks 24-28 in placebo crossover patients. Ustekinumab treatment is associated with significant improvement in HRQoL and sexual difficulties due to psoriasis.