A consensus-based approach on the management of patients with both psoriasis and psoriatic arthritis in the dermatological and rheumatological settings in Italy: The ADOI PSO-Amore Project.

Psoriasis is a complex disease often needing a multidisciplinary approach. In particular, the collaboration between dermatologist and rheumatologist is crucial for the management of patients suffering from both psoriasis (PSO) and psoriatic arthritis (PsA). Here we report a series of recommendations from a group of experts, as a result of a Consensus Conference, defining the circumstances in which it is preferable or even mandatory, depending on the available settings, to rely on the opinion of the two specialists, jointly or in a deferred manner. Indications are given on how to organize a 3rd level joint Dermatology- Rheumatology care unit, in connection with 1st and 2nd level clinicians of both specialties, GPs, and other specialists involved in the management of psoriasis. A potential patient journey is suggested, that can be used as a basis for future design and validation of national and/or local diagnostic therapeutic and assistance pathways.

Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force.

Therapeutic targets have been defined for axial and peripheral spondyloarthritis (SpA) in 2012, but the evidence for these recommendations was only of indirect nature. These recommendations were re-evaluated in light of new insights. Based on the results of a systematic literature review and expert opinion, a task force of rheumatologists, dermatologists, patients and a health professional developed an update of the 2012 recommendations. These underwent intensive discussions, on site voting and subsequent anonymous electronic voting on levels of agreement with each item. A set of 5 overarching principles and 11 recommendations were developed and voted on. Some items were present in the previous recommendations, while others were significantly changed or newly formulated. The 2017 task force arrived at a single set of recommendations for axial and peripheral SpA, including psoriatic arthritis (PsA). The most exhaustive discussions related to whether PsA should be assessed using unidimensional composite scores for its different domains or multidimensional scores that comprise multiple domains. This question was not resolved and constitutes an important research agenda. There was broad agreement, now better supported by data than in 2012, that remission/inactive disease and, alternatively, low/minimal disease activity are the principal targets for the treatment of PsA. As instruments to assess the patients on the path to the target, the Ankylosing Spondylitis Disease Activity Score (ASDAS) for axial SpA and the Disease Activity index for PSoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA) for PsA were recommended, although not supported by all. Shared decision-making between the clinician and the patient was seen as pivotal to the process. The task force defined the treatment target for SpA as remission or low disease activity and developed a large research agenda to further advance the field.

Recommendations for the use of biologics and other novel drugs in the treatment of psoriatic arthritis: 2017 update from the Italian Society of Rheumatology.

OBJECTIVES: To update the 2011 Italian Society of Rheumatology (SIR) recommendations for the use of biologics and other novel agents in the treatment of psoriatic arthritis (PsA). METHODS: To create this new set of recommendations, the SIR "Spondyloartritis and Psoriatic Arthritis study group - A. Spadaro" went through the following steps: literature search, identification of the items of interests for each of the four previously identified clinical domains of PsA and the different treatment phases, achievement of the consensus on all topics, and generation of the recommendations. RESULTS: An update on the available evidence on all of the biologics and new small molecules tested in PsA is reported, comprising the data for each of the individual articular manifestation. Indications for therapy inclusion criteria, choice of the drug, disease assessment, response definition, therapy failure management, and disease remission management for PsA peripheral joint arthritis, enthesitis, dactylitis, and spondylitis are provided. Suggestions for the treatment of patients with PsA and concomitant extra-articular manifestations are also given. CONCLUSIONS: These evidence-based recommendations may be used for guidance in the complex and fast-evolving field of the treatment of PsA.

Pharmacogenomics of multifactorial diseases: a focus on psoriatic arthritis.

This review will outline the current pharmacogenomics knowledge about psoriatic arthritis with a special attention to the perspectives and the challenges for its implementation in the clinical practice. To date, different drugs have been developed to contrast the symptoms and the progression of psoriatic arthritis. However, patients have shown high variability of drug response in relation to their genetic makeup. In this context, the advances made in the knowledge and the potentialities of genome-drugs associations paved the path for the development of a precision medicine. In fact, these associations may be successfully combined with the environment information to provide new strategies able to prevent and improve the disease management as well as to enhance the patients quality of life.

Fatigue in psoriatic arthritis - a cross-sectional study of 246 patients from 13 countries.

OBJECTIVES: Fatigue is an aspect of psoriatic arthritis (PsA), which is important to patients. The objective was to evaluate magnitude of fatigue in PsA patients and to assess factors that might explain high levels of fatigue. METHODS: This was an ancillary analysis of a cross-sectional study in 13 countries of unselected PsA patients who fulfilled the CASPAR criteria. Patient-perceived importance of fatigue was assessed through a priority exercise. Levels of fatigue were assessed by a numeric rating scale (range 0-10). Factors potentially associated with fatigue>5/10: i.e., demographic variables (age, gender, disease duration, education level) and disease related characteristics including joint counts, C-reactive protein, skin psoriasis, axial involvement, enthesitis, dactylitis, structural damage, were assessed by univariate, multivariate logistic and multiple linear regression. RESULTS: In all, 246 patients were analysed: mean±standard deviation age 51.2±13.0years, mean disease duration 9.9±10.1years, mean DAS28 3.5±1.3. Fatigue was ranked second in patient-perceived importance, after pain. Magnitude of fatigue was high: mean fatigue 5.0±3.0. Fatigue>5/10 was well explained (variance explained 73%) by skin psoriasis (odds ratio 4.67 [95% confidence interval 1.05; 20.72]), tender joints (1.30 [1.01; 1.68]) and lower education level (1.09 [1.02; 1.23]). In the multiple linear regression model, fatigue was explained by skin psoriasis, tender joints, enthesitis, female gender, education level. CONCLUSIONS: Fatigue is a priority for PsA patients. Fatigue levels were high in these patients and fatigue>5/10 was mainly associated with disease-related factors but also patient-related variables, indicating that the etiology of fatigue in PsA is multifactorial.

Patient global assessment in psoriatic arthritis - what does it mean? An analysis of 223 patients from the Psoriatic arthritis impact of disease (PsAID) study.

OBJECTIVE: Patient global assessment is a key outcome measure in psoriatic arthritis. To explore the meaning of patient global assessment in psoriatic arthritis by examining associations to domains of health assessed by the Psoriatic arthritis impact of disease score. METHODS: Post-hoc analysis of a multicentre cross-sectional study of patients with psoriatic arthritis. Data collection included patient global assessment, specific joint and skin global patient assessments, Psoriatic arthritis impact of disease questions covering physical (including joints and skin), psychological and social impact, and other comparator outcomes. Univariate analyses (Pearson correlation) and multivariate linear regression were performed to explain patient global assessment and the specific joint and skin global patient assessments. RESULTS: Among 223 patients (mean age: 51.0 [standard deviation, ±13.3] years; mean disease duration: 9.9 [±10.1] years; mean swollen joint count: 4.1 [±5.1]; 84.3% with current psoriasis [mainly of less than 5% body surface area]), 50.2% were females. Mean patient global assessment was 4.8 (±2.7), mean joint and skin patient assessments were respectively 5.6 (±2.5) and 4.1 (±3.0). Intraclass correlation between patient global assessment and joint or skin patient assessment was respectively 0.71 (95% confidence interval, 0.64-0.77) and 0.52 (95% confidence interval, 0.42-0.60). In multivariate analyses, patient global assessment was explained (R(2) of model: 0.754) by coping (ß = 0.287); pain (ß = 0.240); work and/or leisure activities (ß = 0.141); and anxiety (ß = 0.109). CONCLUSIONS: Patient global assessment in psoriatic arthritis was explained mainly by physical, but also psychological aspects of the disease.

The International Dermatology Outcome Measures Group: formation of patient-centered outcome measures in dermatology.

As quality standards are increasingly in demand throughout medicine, dermatology needs to establish outcome measures to quantify the effectiveness of treatments and providers. The International Dermatology Outcome Measures Group was established to address this need. Beginning with psoriasis, the group aims to create a tool considerate of patients and providers using the input of all relevant stakeholders in assessment of disease severity and response to treatment. Herein, we delineate the procedures through which consensus is being reached and the future directions of the project.

A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative.

INTRODUCTION: The objective was to develop a questionnaire that can be used to calculate a score reflecting the impact of psoriatic arthritis (PsA) from the patients' perspective: the PsA Impact of Disease (PsAID) questionnaire. METHODS: Twelve patient research partners identified important domains (areas of health); 139 patients prioritised them according to importance. Numeric rating scale (NRS) questions were developed, one for each domain. To combine the domains into a single score, relative weights were determined based on the relative importance given by 474 patients with PsA. An international cross-sectional and longitudinal validation study was performed in 13 countries to examine correlations of the PsAID score with other PsA or generic disease measures. Test-retest reliability and responsiveness (3 months after a treatment change) were examined in two subsets of patients. RESULTS: Two PsAID questionnaires were developed with both physical and psychological domains: one for clinical practice (12 domains of health) and one for clinical trials (nine domains). Pain, fatigue and skin problems had the highest relative importance. The PsAID scores correlated well with patient global assessment (N=474, Spearman r=0.82-0.84), reliability was high in stable patients (N=88, intraclass correlation coefficient=0.94-0.95), and sensitivity to change was also acceptable (N=71, standardised response mean=0.90-0.91). CONCLUSIONS: A questionnaire to assess the impact of PsA on patients' lives has been developed and validated. Two versions of the questionnaire are available, one for clinical practice (PsAID-12) and one for clinical trials (PsAID-9). The PsAID questionnaires should allow better assessment of the patient's perspective in PsA. Further validation is needed.

Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force.

BACKGROUND: Therapeutic targets have been defined for diseases like diabetes, hypertension or rheumatoid arthritis and adhering to them has improved outcomes. Such targets are just emerging for spondyloarthritis (SpA). OBJECTIVE: To define the treatment target for SpA including ankylosing spondylitis and psoriatic arthritis (PsA) and develop recommendations for achieving the target, including a treat-to-target management strategy. METHODS: Based on results of a systematic literature review and expert opinion, a task force of expert physicians and patients developed recommendations which were broadly discussed and voted upon in a Delphi-like process. Level of evidence, grade and strength of the recommendations were derived by respective means. The commonalities between axial SpA, peripheral SpA and PsA were discussed in detail. RESULTS: Although the literature review did not reveal trials comparing a treat-to-target approach with another or no strategy, it provided indirect evidence regarding an optimised approach to therapy that facilitated the development of recommendations. The group agreed on 5 overarching principles and 11 recommendations; 9 of these recommendations related commonly to the whole spectrum of SpA and PsA, and only 2 were designed separately for axial SpA, peripheral SpA and PsA. The main treatment target, which should be based on a shared decision with the patient, was defined as remission, with the alternative target of low disease activity. Follow-up examinations at regular intervals that depend on the patient's status should safeguard the evolution of disease activity towards the targeted goal. Additional recommendations relate to extra-articular and extramusculoskeletal aspects and other important factors, such as comorbidity. While the level of evidence was generally quite low, the mean strength of recommendation was 9-10 (10: maximum agreement) for all recommendations. A research agenda was formulated. CONCLUSIONS: The task force defined the treatment target as remission or, alternatively, low disease activity, being aware that the evidence base is not strong and needs to be expanded by future research. These recommendations can inform the various stakeholders about expert opinion that aims for reaching optimal outcomes of SpA.

Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry.

BACKGROUND: Some studies have shown that switching patients from one tumor necrosis factor (TNF)-alfa inhibitor to another may be beneficial when they have an inadequate response or an adverse event. OBJECTIVE: We sought to assess the variables predicting the efficacy of the second TNF-alfa inhibitor in patients discontinuing the first TNF-alfa inhibitor. METHODS: Data from all 5423 consecutive patients starting TNF-alfa inhibitor therapy for psoriasis between September 2005 and September 2010 who were included in the Italian Psocare registry were analyzed. RESULTS: In 105 patients who switched to a second TNF-alfa inhibitor who had complete follow-up data, 75% improvement in the Psoriasis Area Severity Index score (PASI 75) was reached by 29% after 16 weeks and by 45.6% after 24 weeks. Patients who switched because of secondary loss of efficacy (loss of initial PASI 75 response) or adverse events/intolerance were more likely to reach PASI 75 than those who switched as a result of primary inefficacy (PASI 75 never achieved) (hazard ratio 2.7, 95% confidence interval 1.3-5.5 vs hazard ratio 2.0, 95% confidence interval 1.0-3.9 and 1, respectively). LIMITATIONS: There was a small number of patients with complete follow-up data. CONCLUSION: PASI 75 response in patients who switched from one anti-TNF-alfa agent to another was significantly reduced in patients who showed primary inefficacy of the first anti-TNF-alfa.

Risk factors of hypertension, diabetes and obesity in Italian psoriasis patients: a survey on socio-demographic characteristics, smoking habits and alcohol consumption.

We evaluated risk factors such as socio-demographic characteristics, smoking habits and alcohol consumption, associated with hypertension, diabetes and obesity in psoriasis patients, in order to plan health education programs that could prevent the onset or progression of co-morbidities. The study population consisted of 1376 patients with psoriasis who were consecutively recruited at 21 Italian Departments of Dermatology. Information concerning socio-demographic variables, smoking and alcohol consumption, and the presence of chronic disorders such as hypertension, type 2 diabetes and obesity was collected. The risk of co-morbidities according to the various exposure variables was calculated using logistic regression models. Psoriasis patients living in extremely urban areas showed the highest risk of diabetes (OR = 1.99, 95% CI 1.06-5.23) and obesity (OR = 2.60, 95% CI 1.10-16.12), as compared to patients living in rural areas. The OR for hypertension was higher for smokers (> 15 cigarettes per day, OR = 1.37, 95% CI 1.01-2.03) and drinkers (> 2 glasses/day of wine, OR = 2.11, 95% CI 1.31-3.40). The OR for diabetes or obesity was higher for drinkers: 1 drink/day (OR = 1.93, 95% CI 1.01-3.67) and > 1 drink/day of spirits (OR = 2.90, 95% CI 1.43-5.82), respectively. The results of our survey highlight the need to detect psoriasis patients with different susceptibilities to co-morbidities in order to plan specific health campaigns aimed at changing people's lifestyles with respect to smoking, drinking and diet.

Impact of body mass index and obesity on clinical response to systemic treatment for psoriasis. Evidence from the Psocare project.

OBJECTIVE: Our aim was to assess the role of the body mass index (BMI) in the clinical response to systemic treatment for psoriasis. METHODS: A nationwide cohort study of patients receiving a new systemic treatment for plaque psoriasis at reference centres in Italy was conducted. Information was gathered through a web-based electronic form. Patients being maintained on the same medication and with data available at 8 and 16 weeks by March 31, 2007, were eligible. The outcome was a reduction in the Psoriasis Area Severity Index (PASI) of at least 75% at follow-up compared to baseline (PASI-75). RESULTS: Out of 8,072 patients enrolled, 2,368 were eligible and analysable at 8 weeks and 2,042 at 16 weeks. PASI-75 was achieved by 819 patients (34.5%) at 8 weeks and 1,034 (50.6%) at 16 weeks. The proportion steadily decreased with increased values of BMI. Compared to normal weight (BMI = 20-24) the adjusted odds ratio for achieving PASI-75 in obese patients was 0.73 (95% CI = 0.58-0.93) at 8 weeks and 0.62 (95% CI = 0.49-0.79) at 16 weeks. The impact of the BMI did not show remarkable variations according to the drug prescribed at entry. CONCLUSION: The BMI affects the early clinical response to systemic treatment for psoriasis.

Analysis of health care and actual needs of patients with psoriasis: a survey on the Italian population.

BACKGROUND: Over recent years the public health system has shown increasing interest in patients' views for use as guideline criteria in evaluating the quality of assistance above all for those patients with chronic diseases. Hence the interest in psoriasis, which is a chronic disease frequently associated with diabetes mellitus, hypertension, obesity, and cardiovascular diseases. The aims of our study were to describe clinic characteristics of patients with psoriasis, the quality of the assistance perceived by patients arrived at outpatients clinics and the information received, in order to identify areas in Italy requiring improvement. METHODS: 1954 patients, aged between 18 and 85 years, were consecutively enrolled at outpatients clinics across 21 Italian provinces over the period December 2004-January 2006. A standardized questionnaire was developed in collaboration with an Italian Association of Psoriatic Patients (A.DI.PSO) and tested in a pilot study. The questionnaire was divided into three sections: the first section included social, demographic and individual variables; the second concerned the quality of the assistance perceived by the patients at public dermatologic clinics and the third focused on the need of information requirements of patients with psoriasis. The chi2 test was used to estimate the association between the categorical variables under study. Kruskal-Wallis test was applied to the interval and ordinal variables. RESULTS: The presence of psoriatic arthritis was reported in 26.0% of patients. Associated chronic diseases included depression (15.4%), hypertension (13.3%), obesity (8.9%) and type 2 diabetes mellitus (7.3%). The study highlighted the need of improvements of health care services at public dermatologic clinics especially in overcoming architectonic barriers and reducing appointment wait-times, particularly in South Italy. However, patients reported a positive relationship with Health System employers due to the confidentiality. This positive impression was confirmed by the observation that dermatologists were considered the best source of information about therapies on psoriasis. CONCLUSION: Our study allowed to identify critical aspects which could be tackled through initiatives with the aim of improving these emerged needs.

An Italian study on psoriasis and depression.

BACKGROUND: Psoriasis is often associated with the risk of physical disability, social discomfort and psychological disorders. OBJECTIVES: The aim of this study was to investigate the prevalence of depressive symptomatology among Italian patients with psoriasis vulgaris, in order to better evaluate the disease severity in this patient population. METHODS: Five thousand Italian patients with psoriasis were mailed the Center for Epidemiological Studies-Depression Scale (CES-D) questionnaire, a 20-item instrument developed to perform epidemiological studies of depressive symptomatology in the general population. Questionnaires with responses to 16 or more items were considered evaluable. RESULTS: We received evaluable questionnaires from 2,391 patients, including 1,528 men (63.9%) and 863 women (36.1%). Depressive symptomatology was observed in 1,482/2,391 patients (62% overall; females, 63%; males, 61%). Men < 40 years of age were significantly more likely to report depressive symptoms than were men > or =40 years of age (67 vs. 58%, respectively; p = 0.002). Depressive symptomatology was more prevalent in psoriatic patients with only primary or secondary education than in psoriatic patients with higher education (51 vs. 32%, respectively; p < 0.02). CONCLUSION: Our results are consistent with previous studies showing that psoriasis is associated with profound psychological morbidity, in particular with depression in a large number of patients. It is important to consider this association in the overall management of psoriasis.