Comparative effectiveness of tildrakizumab 200 mg versus tildrakizumab 100 mg in psoriatic patients with high disease burden or above 90 kg of body weight: a 16-week multicenter retrospective study - IL PSO (Italian landscape psoriasis).

PURPOSE: Tildrakizumab is a selective inhibitor of IL-23 approved for the treatment of moderate-to-severe plaque psoriasis in two dosages. We conducted a 16-week multicenter retrospective study to compare the effectiveness and safety of tildrakizumab 200 mg versus tildrakizumab 100 mg in patients with a high disease burden or high body weight. MATERIALS AND METHODS: Our retrospective study included 134 patients treated with tildrakizumab 200 mg and 364 patients treated with tildrakizumab 100 mg from 28 Italian Dermatology Units affected by moderate-to-severe plaque psoriasis. The patients had a body weight above 90 kg or a high disease burden (Psoriasis Area and Severity Index [PASI] ≥ 16 or the involvement of difficult-to-treat areas). We evaluated the effectiveness of tildrakizumab at the week-16 visit in terms of PASI90, PASI100 and absolute PASI ≤ 2. RESULTS: After 16 weeks of treatment with tildrakizumab 200 mg, PASI90 was reached by 57.5% of patients and PASI100 by 39.6% of patients. At the same time point, 34.3% and 24.2% of patients treated with tildrakizumab 100 mg achieved PASI90 and PASI100, respectively. CONCLUSIONS: Our data suggest that tildrakizumab 200 mg has better effectiveness than tildrakizumab 100 mg in patients with a body weight ≥ 90 kg and a high disease burden.

The role of lifestyle and nutrition in psoriasis: Current status of knowledge and interventions.

Extrinsic environmental factors, including patient lifestyle (alcohol intake, smoking, stress, sleep disturbances, and sedentary habit), diet and single nutrients intake may affect psoriasis clinical presentation, severity, and course. All English language articles dealing with psoriasis and lifestyle factors or diet gathered by an extensive PubMed search were carefully examined in order to explore their impact on the disease. Current authoritative knowledge confirms that low-calories, Mediterranean, and protein restricted/vegetarian diets may be beneficial. Psoriatic patients are also recommended to engage regular physical activity, to avoid alcohol intake and to consume fish rich in omega-3 polyunsaturated fatty acids, as well as fruit and vegetables. Prebiotics and probiotics may also provide potential benefit, whereas vitamin D supplementation and gluten-free diet are useful in selected cases only. Changing of dietary and lifestyle habits alone does not replace conventional treatment, but must be considered as an adjuvant. Physicians may play a crucial role, by adequately acknowledging psoriatic patients on the advantages of proper lifestyle and diet habits as well as providing clues to reliable sources of dietary advice.

Treat-to-Target Approach for the Management of Patients with Moderate-to-Severe Plaque Psoriasis: Consensus Recommendations.

INTRODUCTION: Treat-to-target strategies are used in several chronic diseases to improve outcomes. Treatment goals have also been suggested for psoriasis, but there is currently no consensus on targets, and guidance is needed to implement this strategy in clinical practice. The project 'Treat to Target Italia' was launched by a scientific board (SB) of 10 psoriasis experts to generate expert consensus recommendations. METHODS: On the basis of the published literature, their clinical experience, and the results of a survey among Italian dermatologists, the SB identified four relevant topics: (1) clinical remission; (2) quality of life; (3) abrogation of systemic inflammation; (4) safety. They drafted 20 statements addressing these four topics and submitted them to a panel of 28 dermatologists, in a Delphi process, to achieve consensus (greater than 80% agreement). RESULTS: Consensus was reached on all statements. Treatment goals defining clinical remission should include a 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI90 response) or an absolute PASI score of less than or equal to 3. Patient's quality of life and satisfaction are important targets. If PASI targets are achieved, there should be no or very low impact of psoriasis on quality of life [Dermatology Life Quality Index (DLQI) score less than or equal to 3]. If PASI or DLQI goals are not achieved within 3-4 months, treatment should be changed. Abrogation of systemic inflammation may be crucial for preventing or delaying inflammatory comorbidities. Safety is an equally important target as efficacy. CONCLUSION: These 20 consensus statements define the parameters of a treat-to-target strategy for psoriasis in Italy. It is hoped that use of these in the management of patients with psoriasis will improve treatment outcomes and patient health-related quality of life.

Psoriasis and its management in women of childbearing age: tools to increase awareness in dermatologists and patients.

Psoriasis is a common, chronic inflammatory disease with a multifactorial pathogenesis. Mean age at presentation of psoriasis is 28 years in women, which is almost the height of fertility age. Since women of childbearing potential represent a significant proportion of psoriatic patients, the impact of psoriasis and its treatment on fertility, pregnancy, and breastfeeding should be highlighted for a proper management. Therefore, when approaching to a psoriatic woman of childbearing age, Healthcare Providers should be adequately informed and ready to provide the patients with answers to the most frequently asked questions. The Italian Society of Dermatology and Venereology (SIDeMaST) has fostered a Task Force named "Psoriasis in Women of Childbearing Age" which is composed by a group of Italian female dermatologists with a high expertise in psoriasis treatment. The aims of the Task Force are to increase awareness of the disease and its treatment in patients of childbearing age among both dermatologists and women affected by psoriasis and to encourage counselling on family planning. With the aim of providing a real support for the proper management of the delicate journey to motherhood, the Italian Task Force has published two different informative booklets addressed to patients and dermatologists which focus on the main issues regarding psoriasis in women of childbearing age.

Biologic agents perception in patients attending for the first-time to psoriasis centers: a multicenter Italian survey.

BACKGROUND: Inadequate treatment and delayed access to care represent critical issues regarding psoriasis. In Italy, patients treated with biologics are scanty and patients' misinformation could interfere with both biologics prescription and access to care. Literature provide data on disease awareness and perception about biologics in already-treated patients, but there is a lack of information concerning patients never treated with such drugs. METHODS: We conducted a national survey including three academic-based psoriasis care centers at Bologna, Rome and Catania. A questionnaire named Psoriatic Patients's Awareness on Biologics (PPAB) was administered to patients naïve for biologics and accessing for the fist-time to a psoriasis care center. RESULTS: Patients from Northern Italy referred to more reliable sources of information and awareness on biologics decreased from North to South. The increase of the Psoriasis Area Severity Index was associated to unawareness about biologics and impaired self-evaluation on the eligibility to treatment. Patients under systemic conventional /multiple therapy were more likely to be unaware about biologics. CONCLUSIONS: Our survey demonstrates that psoriatic patients' awareness is still an unmet need. For more, patients potentially eligible for biologics (severe or treated with systemic conventional/multiple therapy) were less informed. We believe that patients' misinformation could have delayed the access to a psoriasis care center, so that when patients sought help their condition was more severe and required systemic conventional/multiple therapy. Our results reiterate the importance of physicians in the information process and urge the need of a common network among office dermatologists, general practitioners and psoriasis care centers.

Topical tacrolimus in adult atopic dermatitis: a consensus based on a 15-year experience.

Atopic dermatitis (AD) is one of the most common cutaneous inflammatory diseases both in adults and in children. It is a chronic, remitting-relapsing dermatitis, primarily managed by dermatologists, but also by allergists and primary care physicians. Due to coexistence of comorbidities, often a multidisciplinary team is required. Topical calcineurin inhibitors (TCIs - i.e. tacrolimus and pimecrolimus) are a class of steroid-sparing, anti-inflammatory agents that have been shown to be efficacious for the treatment of AD acute flares and in maintenance therapy. In particular, the application of tacrolimus ointment twice daily reduces AD severity and pruritus. Moreover, maintenance therapy with an intermittent application of tacrolimus to recurrent skin sites (proactive therapy) decreases frequency and severity of relapses. Many studies have also assessed the efficacy of TCIs in disorders other than AD. Although US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) issued a "black box warning" regarding the possible cancerogenic activity of these drugs, there is currently no strong evidence of an increased rate of malignancy in treated patients, and observational data from postmarketing surveillance studies have shown no safety concerns. A panel of dermatologists have thoroughly discussed the use of tacrolimus in AD after 15-year experience. The experts focused on AD flare treatment, maintenance therapy and management of side effects. Consensus was reached on some areas of interest, namely the stages of AD in which tacrolimus is recommended, the amount of drug to be applied, how to manage side effects, and how to improve patient's compliance. Moreover, the panel of experts recommended to perform randomized clinical trials to confirm the efficacy of tacrolimus off-label use, which led to successful outcomes in other skin diseases.

Ultrasound assessment of the keratolytic effect of a 50% urea anhydrous paste on psoriasis plaques: a prospective study.

BACKGROUND: The keratolytic effect of urea is well-known, although the majority of the available studies rely on clinical observation only. The aim of this open trial was to evaluate, through clinical and ultrasound assessment, the efficacy and tolerability of a 50% urea anhydrous paste on hyperkeratotic psoriatic plaques. METHODS: Twenty-five patients (12 male, 13 female; age: 35-75 years) with plaque psoriasis characterized by an evident hyperkeratotic component were enrolled. One target lesion was selected in each patient that was instructed to apply the 50% urea anhydrous paste twice a day for up to 3-week study duration. RESULTS: Clinical clearance of hyperkeratosis at day 21 was observed in 23 out of 25 plaques (92%), with nine (36%) and ten (40%) patients already reaching clear status respectively at day 7 and 14. Ultrasound significant reduction of the mean epidermal thickness score was also observed at the same time-points. No side effects were reported and all patients rated the product as excellent in terms of cosmetic acceptability. CONCLUSIONS: The tested product resulted to be an effective keratolytic agent in plaque psoriasis. Strength of our study was the ultrasound assessment, allowing to objectively confirm and correlate the epidermal changes seen at clinical evaluation.

A multicenter retrospective case-control study on Suspension of TNF-inhibitors and Outcomes in Psoriatic patients (STOP study).

BACKGROUND: There is limited information on patients undergoing withdrawal after long-term treatment with anti-TNF alpha drugs and their clinical evolution during the post-interruption period in real-life settings. The purpose of the present retrospective case-control study was to provide a clearer insight into the clinical management of psoriatic patients with adequate response to long-term adalimumab, etanercept and infliximab treatment once these biologic agents are interrupted. METHODS: A total of 270 patients undergoing anti-TNF alpha agents discontinuation and 253 controls treated with a continuous regimen were enrolled. The primary endpoint was the change in disease activity in each study group over six months (or until treatment of psoriatic recurrence) as measured by the PASI score every month. Then, we evaluated the rate of and time to relapse, the rate of clinical worsening (PASI≥5) and the clinical variables influencing the loss of response. RESULTS: Our study showed that about 50% of patients achieving a long-term and optimal response to the aforementioned anti-TNF alpha agents did not experience any relapse over a 6-month follow-up period after withdrawal. We also observed that subjects displaying a complete remission (PASI=0) at anti-TNF alpha therapy withdrawal experienced less frequently disease worsening and/or relapse compared to subjects having a PASI>0. CONCLUSIONS: Our findings confirmed that all three anti-TNF alpha agents tend to retain their effectiveness upon re-administration in case of recurrence, even if they have been previously used for long time.

Role of the imaging techniques in the diagnosis and staging of hidradenitis suppurativa.

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease mainly affecting the axillary, inguinal and anogenital regions, and characterized by the presence of nodules, abscesses and sinus tracts and scarring. Clinical examination alone may underestimate the disease extension and severity. Some non-invasive skin imaging techniques such as ultrasound, magnetic resonance imaging, computed tomography, positron-emission tomography and dermoscopy, have been demonstrated to be useful in the diagnosis and management of HS. They may reveal some findings not appreciable at naked eye evaluation, suggesting the diagnosis in case of minimal/mild presentation or in non-active long-lasting cases and allowing a more accurate staging, treatment planning and monitoring of this debilitating disease.

Validation and Field Performance of the Italian Version of the Psoriatic Arthritis Screening and Evaluation (PASE) Questionnaire.

Psoriatic arthritis (PsA) is a potentially severe inflammatory condition (entheso-arthro-osteopathy), and early diagnosis is important to guide treatment choices in patients with psoriasis. The objective of this study is to further validate the PsA Screening and Evaluation (PASE) questionnaire, and to assess its field performance. Data were collected in 10 Italian centres, and the PASE was administered at baseline, after 3 days and after 3 months. The Skindex-29 was also administered. To determine the best cut-off value to identify patients with PsA we produced receiver operating characteristic (ROC) curves using the rheumatologist's diagnosis as outcome. Of the 298 patients that were enrolled, 28% were classified as having PsA according to the CASPAR criteria, while 19% had received a diagnosis of PsA from a rheumatologist. PASE score were always significantly different in patients with or without PsA, while Skindex-29 scores never were. The internal consistency of the PASE was very good (Cronbach's α of 0.90-0.95), the test-retest reliability was also very high (intraclass correlation coefficients 0.91-0.93), and the PASE scores showed good responsiveness to clinical change over time. The optimal cut-off identified through the ROC curves was ≥ 48 on the total PASE score, which was able to distinguish PsA from non-PsA patients with a 73.2% sensitivity and a 76.1% specificity. Our results confirm the good psychometric properties of the PASE, and indicate that it may be a useful tool for the dermatologists, both to screen for PsA and to obtain a standardized patient-reported measure to monitor and evaluate the health status of the patients with PsA.

Psoriasis awareness among Italian patients: results of a nationwide survey.

BACKGROUND: This was a prospective, multicentre study conducted in 14 Italian psoriasis referral centres (January-June 2014) with the objective of identifying factors associated with different levels of patient awareness on psoriasis. METHODS: Overall, 298 patients (119 females, mean age 49.4 years, range 20-88) with a diagnosis of psoriasis (median of 14.1 years) were enrolled. Patients were more knowledgeable about the pathogenic nature of their condition compared with the other parameters (diagnosis, clinical course, prognosis, effect on QoL). Variables associated with significantly higher awareness, included years of education (the higher the educational levels the greater awareness), internet usage, other family member with the disease, diet rich in fruit/vegetables, cigarette smoking and bone and joint involvement. RESULTS: Older age, diabetes, and alcohol abuse were inversely associated. CONCLUSIONS: Having established factors that affect awareness in our patients we can now go on to devise educational interventions to address these needs.