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Background: Treatment of prurigo nodularis (PN) is challenging and new treatment options are needed. Objective: To evaluate the efficacy and safety of two oral doses of the kappa opioid agonist and mu opioid antagonist nalbuphine extended release (NAL‐ER) tablets in a phase 2, multicentre, randomized, double‐blind, placebo‐controlled trial with an open‐label, 50‐week extension phase. Methods: Subjects with moderate‐to‐severe PN were randomized to NAL‐ER 81 mg (NAL‐ER81) or 162 mg (NAL‐ER162) tablets twice‐daily or placebo for 8 weeks of stable dosing following a 2‐week titration period. Subjects completing Week 10 with a Worst Itch Numerical Rating Scale (WI‐NRS) score ≥5 at the time of rollover (or during the observation period) were eligible for open‐label treatment. Results: Of 63 randomized subjects, 62 were treated and comprised the modified intent‐to‐treat population (MITT), 50 completed 10 weeks of treatment. In the MITT analysis, 8 subjects (44.4%) treated with NAL‐ER162 (P = 0.32) and 6 (27.3%) treated with NAL‐ER81 (P = 0.78) achieved ≥30% reduction from baseline in 7‐day WI‐NRS at Week 10 (primary efficacy endpoint) vs. 8 (36.4%) in the placebo group. Itch reduction was significant among 8/12 (66.7%) subjects completing Week 10 treated with NAL‐ER162 vs. placebo (8/20, 40.0%; P = 0.03). Additionally, 6 subjects (33.3%) treated with NAL‐ER162 and 3 (13.6%) treated with NAL‐ER81 achieved ≥50% reduction from baseline in 7‐day WI‐NRS at Week 10 (coprimary endpoint). Extended open‐label treatment was associated with further improvements in itch reduction and favourable changes in PN lesion activity as assessed by Prurigo Activity Score. Adverse events occurred predominantly during dose titration and were of mild‐to‐moderate severity. The safety profile did not change with extended open‐label treatment. Conclusion: In adult subjects with PN, oral treatment with NAL‐ER 162 mg twice daily provided measurable anti‐pruritic efficacy in subjects completing ≥10 weeks of treatment and was well tolerated (ClinicalTrials.gov: NCT02174419). [ABSTRACT FROM AUTHOR]

Background Fumaric acid esters ( FAEs) are recommended in international guidelines for induction and long-term treatment of adults with moderate-to-severe chronic plaque psoriasis. The fixed combination Fumaderm® is approved in Germany, with dimethyl fumarate ( DMF) being the main active ingredient. Objectives To assess the efficacy and safety of a new formulation of DMF ( LAS41008), compared with placebo and Fumaderm®, in adults with moderate-to-severe chronic plaque psoriasis. Methods In this phase III, double-blind, placebo-controlled, noninferiority trial ( BRIDGE, NCT01726933, Eudra CT 2012-000055-13), patients were randomized to receive LAS41008, Fumaderm® or placebo (2 : 2 : 1) for 16 weeks, uptitrating to a maximum daily DMF dose of 720 mg, depending upon individual response. The coprimary end points were the percentage of patients achieving ≥ 75% improvement in Psoriasis Area and Severity Index ( PASI 75) and the percentage achieving a score of 'clear' or 'almost clear' in the Physician's Global Assessment ( PGA) at week 16. Results In total, 671 patients were randomized and included in the full analysis set ( n = 267, LAS41008; n = 273, Fumaderm®; n = 131, placebo). At week 16, 37·5% of patients treated with LAS41008 achieved PASI 75, compared with 15·3% receiving placebo (superiority for LAS41008 vs. placebo: P < 0·001) and 40·3% receiving Fumaderm® (noninferiority for LAS41008 vs. Fumaderm®: P < 0·001). Overall, 33% of patients treated with LAS41008 were 'clear' or 'almost clear' in the PGA at week 16, compared with 13·0% receiving placebo ( P < 0·0001; LAS41008 superiority vs. placebo) and 37·4% receiving Fumaderm®. Most treatment-related adverse events were classed as 'mild' in severity. Conclusions LAS41008 ( DMF) is effective in the treatment of adults with moderate-to-severe chronic plaque psoriasis. [ABSTRACT FROM AUTHOR]

Dermatophyte infections are the most common fungal infections in humans; among them, tinea capitis (TC) – the most contagious fungal infection – is caused by anthropophilic, zoophilic and geophilic dermatophytes. The purpose of this systematic review was to determine the different aetiological variants involved in TC and the overall epidemiology of the causes of this infection in the last two decades. We searched the MEDLINE (PubMed) and Embase databases for articles published from July 2000 to August 2019 using the following search terms: 'Tinea capitis', 'Africa', 'America', 'Asia', 'Europe', 'Oceania', and the names of the countries on each continent. The flow of information through the different phases in this systematic review was depicted using a PRISMA flow diagram, which mapped the number of records identified, included and excluded, and the reasons for exclusion. Our findings indicate that the frequency of different aetiologic agents of TC in the reported studies varied globally, from 0.4–87.7% in Africa, 0.2–74.0% in North America, 0.0–91.2% in Eastern Asia, 0.0–69.0% in Eastern Europe and 2.9–86.4% in Oceania. Microsporum canis is the most frequent reported zoophilic agent worldwide, while Trichophyton violaceum and Trichophyton tonsurans are the predominant anthropophilic agents. Over time, the frequency of these latter fungal infections has increased globally, and these fungi have become the major species globally. Anthropophilic transmission – the most prevalent type of transmission – could be explained by two factors: (i) the socioeconomic status of affected countries and population groups with associated risk factors and (ii) movement of populations importing new causes of infection to areas where they had not been encountered previously. We observed that intercontinental migration and travel; globalization; environmental, climatic and ecological changes; and accelerated evolution of health technologies may influence the observed epidemiological changes and, consequently, contributed to the variations in the global status of TC. [ABSTRACT FROM AUTHOR]

Hidradenitis suppurativa (HS) can cause considerable impact on several aspects of quality of life. Sexuality is a central aspect of quality of life. In recent years, there has been an increase in the number of articles on HS and sexuality. To achieve our aim of synthesizing the available scientific evidence on HS and sexual health, we conducted a systematic review in February 2020. The clinical databases used included Medline and Embase. All types of epidemiological articles were included; reviews, guidelines, protocols, conference abstracts and case report articles were excluded. Eleven studies were included for review, representing 42 729 patients with HS. The most common study design was cross‐sectional with or without comparison group(s), conducted in an outpatient setting or through surveys. Prevalence of sexual dysfunction ranged between 51–62%, and in the case of erectile dysfunction, a specific kind of sexual dysfunction affecting penile erection, it ranged from between 52% and 60% of patients studied using validated questionnaires. Potential risk factors for sexual dysfunction among men and women were identified, mainly related to disease activity, symptoms and partners. Mood disorders like depression and anxiety appear to be associated with sexual dysfunction. Women were more affected by sexual distress. HS patients with sexual dysfunction had a decreased overall quality of life. With respect to treatment, surgery did not improve sexual function and there is no scientific evidence regarding medical treatments. Patients stated that they would like to treat their sexual problems with healthcare professionals. In conclusion, sexual and erectile dysfunction are common in HS patients, and negatively affect their quality of life. There are clinical factors potentially associated with this which should be identified and treated by dermatologists in the comprehensive care of HS patients. Prospective studies are needed to provide more scientific evidence on this unmet need. [ABSTRACT FROM AUTHOR]

Regarding the prevalence of psoriasis flare-ups, amid 414 cutaneous reactions, authors stated that it occurred only in two patients, which seems to be very rare. Regarding COVID-19 vaccination, the patient received his first dose of Pfizer-BioNTech BNT16B2b2 mRNA vaccine and experienced only pain at the site of vaccine injection lasting for 24 hours. Psoriasis flare-up associated with second dose of Pfizer-BioNTech BNT16B2b2 COVID-19 mRNA vaccine. [Extracted from the article]

Summary: Background: Secukinumab is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin‐17A. Objectives: To assess the efficacy and safety of different maintenance dosing regimens of secukinumab 300 mg based on Psoriasis Area and Severity Index (PASI) response at week 24 in patients with moderate‐to‐severe plaque psoriasis. Methods: OPTIMISE was a randomized, open‐label, rater‐blinded phase IIIb study. Patients (n = 1647) received secukinumab 300 mg at baseline; weeks 1, 2, 3 and 4; and every 4 weeks (q4w) to week 24. At week 24, PASI 90 responders (≥ 90% improvement in PASI; n = 1306) were randomized to secukinumab 300 mg q4w (n = 644) or q6w (n = 662) to week 52, and PASI ≥ 75 to < 90 responders (n = 206) were randomized to secukinumab 300 mg q4w (n = 114) or q2w (n = 92) to week 52. Results: PASI 90 response was maintained at week 52 by 85·7% of patients with q4w dosing vs. 74·9% with q6w dosing (odds ratio 1·91, 95% confidence interval 1·44–2·55). The primary end point, noninferiority of q6w vs. q4w dosing, was not met. In PASI ≥ 75 to < 90 responders, the proportion of patients with PASI 90 response at week 52 was numerically higher in the q2w vs. the q4w group (57% vs. 46·5%, respectively, P = 0·10). Heavier patients (≥ 90 kg) demonstrated numerically higher PASI 90 response with the q2w (57·1%) vs. the q4w regimen (40%, P = 0·11). Conclusions: Standard q4w dosing of secukinumab 300 mg is the optimal dosing regimen to achieve and maintain clear or almost clear skin. Patients with body weight ≥ 90 kg not achieving PASI 90 at week 24 may benefit from the q2w dosing regimen. What's already known about this topic? Individual responses to biologics in patients with psoriasis vary considerably and there may be a need to individualize treatment.Dose optimization strategies of currently available biologic drugs have been investigated mainly in rheumatic disorders.Secukinumab has shown long‐term PASI 90/100 responses (percentage improvement in Psoriasis Area and Severity Index) to year 5 in patients with moderate‐to‐severe plaque psoriasis when used at the dose of 300 mg every 4 weeks. What does this study add? Standard every 4 week (q4w) dosing of secukinumab 300 mg is the optimal regimen to achieve and maintain clear or almost clear skin at week 52; the majority of the patients (85·7%) maintain PASI 90 at week 52.Superiority of intensified (q2w) dosing over the q4w regimen could not be claimed.However, patients with a higher body weight (≥ 90 kg) not achieving PASI 90 response at week 24 may benefit from q2w dosing. Linked Comment: Morita and Ikumi. Br J Dermatol 2020; 182:264–266. [ABSTRACT FROM AUTHOR]

Background: Although chronic pruritus affects a large part of the population, its reliable assessment remains difficult. Electronical diaries (eDiaries) are often used in multicentre clinical trials. The ItchApp© for Android was developed to assess itch intensity and course and was validated for the German language in 2017. Objective: To validate ItchApp© for the use in the Polish and US English languages. Methods: Fifty‐three subjects in Poland and thirty subjects in the USA with chronic pruritus completed the paper‐based and app‐based questionnaires. These questionnaires contained items for measuring the itch intensity, including a numerical rating scale (NRS) and verbal rating scale (VRS), and for detecting the change of pruritus since the beginning of treatment. Results: The ItchApp© showed a high level of test–retest reliability [Intraclass correlation, Kappa and Kendall‐Tau B coefficients: 0.915–1.000 (Poland) and 0.863–1.000 (USA)]. The convergent validity showed strong correlation between the itch intensity scales on the ItchApp© (Items II‐IV = VRS mean, NRS mean and NRS worst) and the paper‐based itch intensity scales (mean and worst: VRS, NRS, VAS) [Spearman‐Rho and Pearson correlation coefficients: 0.710–0.987 (Poland) and 0.646–0.954 (USA)]. The ItchApp© items moderately correlated with the ItchyQol scores [Spearman‐Rho and Pearson correlation coefficients: 0.303–0.554 (Poland) and 0.275–0.447 (USA)]. After completing the ItchApp© questionnaire, a feasibility questionnaire was completed and showed that subjects feel the app is well suited for assessing pruritus. Conclusion: We provide evidence for the ItchApp© as a validated eDiary for the assessment of pruritus in Polish and US English languages, enabling its use in multicentre international clinical trials. [ABSTRACT FROM AUTHOR]

Background Although acne vulgaris is a common skin disorder, limited epidemiological data exist specifically for European populations. Objective To determine the prevalence of self-reported acne among young people in Europe and evaluate the effect of lifestyle on acne. Methods We conducted a cross-sectional population-based online survey in representative samples of individuals aged 15–24 years in Belgium, Czech and Slovak Republics, France, Italy, Poland and Spain (n = 10 521), identified by a quota sampling method based on age, geographic location and socio-professional category. Results The overall adjusted prevalence of self-reported acne was 57.8% (95% confidence interval 56.9% to 58.7%). The rates per country ranged from 42.2% in Poland to 73.5% in the Czech and Slovak Republics. The prevalence of acne was highest at age 15–17 years and decreased with age. On multivariate analysis, a history of maternal or paternal acne was associated with an increased probability of having acne (odds ratio 3.077, 95% CI 2.743 to 3.451, and 2.700, 95% CI 2.391 to 3.049, respectively; both P < 0.0001), as was the consumption of chocolate (OR 1.276, 95% CI 1.094 to 1.488, for quartile 4 vs. quartile 1). Increasing age (OR 0.728, 95% CI 0.639 to 0.830 for age 21–24 years vs. 15–17 years) and smoking tobacco (OR 0.705, 95% CI 0.616 to 0.807) were associated with a reduced probability of acne. Conclusion The overall prevalence of self-reported acne was high in adolescents/young adults in the European countries investigated. Heredity was the main risk factor for developing acne. [ABSTRACT FROM AUTHOR]

Background Microchimerism is defined as a stable presence of low numbers of cells derived from a different individual due to cell transfer between twins or between mother and fetus during pregnancy. Objective Fetal cells in the organism of the mother ( FMc) are postulated to play a role in autoimmune diseases. Psoriasis is a disease which has an autoimmune component, but no study on microchimerism in this disease has been reported. Methods The easiest way to detect microchimerism is to look for male cells in blood or other tissues of a woman who previously delivered a son. Here, we looked for the presence of male cells in mononuclear cell subpopulations from peripheral blood and in skin samples of women with psoriasis and of healthy women. Results We detected FMc in similar proportions of patients and controls in CD4+, CD8+ and CD34+ cells, whereas in CD34- cells they were present in higher fraction of controls, and similar but non-significant difference was observed in CD19+ cells. No microchimeric cells were detected in patients' skin samples, both from affected and non-affected skin, or in skin tissue from healthy control individuals. Conclusion Our result does not prove the involvement of microchimerism in the aetiology of psoriasis. [ABSTRACT FROM AUTHOR]

Background: Hand eczema (HE) is the most common skin disease affecting hands. Although the current treatment guidelines do not recommend use of systemic antihistamines as routine therapy, they seem to be widely used by physicians handling with this problem. Objective: The aim of the study was to investigate the attitude to prescribe systemic antihistamines in HE. Material and methods: A 10-item questionnaire was distributed among physicians participating in regional dermatological conferences. 127 valid questionnaires were analysed. Results: A total of 127 physicians participated in the survey. 124 (97.6%) responders prescribe antihistamines in HE and 16 (12.6%) subjects declared routine use of oral antihistamines in the HE management. Significantly more dermatologists than other specialists used antihistamines in the treatment of HE accompanying atopic dermatitis (77.8% vs. 54.5%, P < 0.01) and dermatologists significantly more commonly used antihistamines in HE due to their anti-inflammatory properties (40.3% vs. 20.0%, P = 0.02). Regarding the type of eczema, antihistamines were prescribed most frequently in acute allergic HE (n = 92, 72.4%) and in HE accompanying atopic dermatitis (n = 86, 67.7%). Conclusions: Despite the lack of the large, randomized, controlled studies on the effectiveness of the systemic antihistamines in the treatment of HE, this type of therapy seems to be prevalently used among the physicians. [ABSTRACT FROM AUTHOR]

Background: Study TR03 evaluated the safety and efficacy of nalbuphine ER for prurigo nodularis (PN; NCT02174419). Objective: We conducted supplementary analyses to assess the psychometric properties of the Worst Itch Numeric Rating Scale (WI‐NRS), the TR03 primary endpoint. Methods: Study TR03 was a double‐blind, placebo‐controlled, phase 2 trial in PN patients with documented scores ≥5 on the WI‐NRS (0 [no itch]–10 [worst itch imaginable]) on ≥5 of 7 days before baseline. Using TR03 data, the WI‐NRS's psychometric properties, including reliability, validity and ability to detect change, were evaluated. A responder threshold was estimated to facilitate interpretation of WI‐NRS score changes. Results: Amongst 62 treated patients, improvements in mean [SD] (median) WI‐NRS scores were observed between baseline (8.2 [1.21] (8.1)) and week 10 (5.8 [2.43] (6.0)). The WI‐NRS had an intraclass correlation coefficient of 0.96 (95% confidence interval, 0.93–0.98) in 42 patients who had stable Itch verbal rating scale (VRS) scores from week 9–10, supporting strong test–retest reliability. Construct validity was supported, with strong correlations at week 10 with Average Itch NRS (r = 0.87) and Itch VRS single‐day/weekly mean scores (r = 0.81/0.89) and moderate correlations with ItchyQoL™ total/domain scores (r = 0.41–0.43). The WI‐NRS discriminated between predefined severity subgroups based on the Itch VRS and detected changes in itching severity (effect‐size estimate: −2.05; standardized response mean: −1.21). An anchor‐based threshold based on a two‐category improvement in the single‐day Itch VRS suggests a responder threshold of ≥3.8 points (~40% improvement). Conclusions: The WI‐NRS demonstrates good measurement properties, supporting its use in evaluating treatment change in PN. [ABSTRACT FROM AUTHOR]

Background The management of hidradenitis suppurativa ( HS) is still challenging, and new treatment methods are necessary. Acitretin seems to be a promising agent in HS management; however, literature data are limited. Objectives To investigate the clinical efficacy of acitretin monotherapy in 17 patients with long-standing and recalcitrant HS. Simultaneously, an assessment of quality of life was carried out. Methods The study was conducted with a group of 17 patients with HS. Patients were treated with acitretin for up to 9 months and examined at baseline, after 1 month, and then every 3 months from baseline. The clinical extent of disease severity was measured with the HS Severity Index ( HSSI), Hurley scoring system, Physician's Global Assessment and Dermatology Life Quality Index ( DLQI). Results Nine patients (53%) finished the whole 9 months of acitretin treatment. The mean acitretin dose was 0·56 ± 0·08 mg kg−1 daily. A significant improvement of clinical manifestation ( HSSI, DLQI) was observed after only 1 month of therapy, and further improvement was recorded during the next few months. Overall, eight subjects (47%) fulfilled the criteria for response (HSSI ≥ 50% reduction from baseline). The dropout rate was 47%, due mostly to drug ineffectiveness and adverse events. Discontinuation of treatment resulted in deterioration or relapse of HS 2-8 months after acitretin cessation, in all but one patient. Conclusions HS treatment with acitretin seems to be a promising method of disease management. However, due to the high daily dosage, its usage may be limited. [ABSTRACT FROM AUTHOR]

Core outcome sets (COSs) are an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. Tsekhe aim of our position paper by the European Academy of Dermatology and Venereology (EADV) Task Force on Quality of Life and Patient Oriented Outcomes was to identify the challenges and Patient Oriented Outcomes advantages in the development of COSs within dermatological QoL research. Twelve EADV Task Force multidisciplinary team members presented a total of 101 items (51 advantages and 50 disadvantages). All participants considered that COS are beneficial for comparison between different studies, treatments, dermatological diseases, geographical location and ethnicities. In conclusion, the EADV Task Force on Quality of Life and Patient Oriented Outcomes has recognized the primacy of advantages of COS and deliberated that the disadvantages in COS are related to development process and use of COS. [ABSTRACT FROM AUTHOR]

Background Itching is a cardinal symptom of atopic dermatitis (AD). Objective The study aim was to evaluate the relationships between pruritus and stress, health-related quality of life (HRQoL) and depression in adult patients with AD. Methods Eight-nine patients (30 men and 59 women) with AD were included. Demographic and clinical data were collected. The intensity of pruritus was assessed according to the 10-point Visual Analogue Scale (VAS) and the 4-Item Itch Questionnaire, HRQoL according to Dermatology Life Quality Index, and depression symptoms with Beck's Depression Inventory (BDI). Stress experienced by patients was evaluated with Social Readjustment Rating Scale and Stress Self-assessment Scale. Results The mean intensity of pruritus according to VAS was 7.9 ± 2.2 points, and according to 4-Item Itch Questionnaire 14.0 ± 4.4 points. The intensity of pruritus was related to the stress experienced by the patients prior to disease exacerbation (ρ = 0.37, P < 0.001). A significant correlation between pruritus and HRQoL was also found (VAS: ρ = 0.5, P < 0.001, 4-Item Itch Questionnaire: ρ = 0.5, P < 0.001) as well as between pruritus and BDI (VAS: ρ = 0.44, P < 0.001, 4-Item Itch Questionnaire: ρ = 0.51, P < 0.001). Patients with symptoms suggesting depression had more intense pruritus compared with the rest of patients (VAS: 9.1 ± 1.6 vs. 7.6 ± 2.2 points, P = 0.004; 4-Item Itch Questionnaire: 17.3 ± 2.5 vs. 13.1 ± 4.4 points, P < 0.001). Conclusions Itching intensity in AD plays an important role in determining patients' psychosocial well-being. Patients with atopic dermatitis require an effective, long-term antipruritic therapy to improve their QoL and reduce the potential risk of depression. [ABSTRACT FROM AUTHOR]

Background: Dermatophytosis is a world‐wide distributed common infection. Antifungal drug resistance in dermatophytosis used to be rare, but unfortunately the current Indian epidemic of atypical widespread recalcitrant and terbinafine‐resistant dermatophytosis is spreading and has sporadically been reported in Europe. Objectives: To explore the occurrence of clinical and mycological proven antifungal drug resistance in dermatophytes in Europe. Methods: A standardized questionnaire was distributed through the EADV Task Force of Mycology network to dermatologists in Europe. Results: Representatives from 20 countries completed the questionnaires of which 17 (85 %) had observed clinical and/or mycological confirmed antifungal resistance, two countries published cases of antifungal resistance and one country had no known cases. Conclusions: This pilot study confirms that both clinical and mycological antifungal resistance exist in Europe. [ABSTRACT FROM AUTHOR]

Background: Itch is a common symptom in the general population. Affected individuals often do not seek medical consultation and rely on Internet searches to obtain information regarding their itch. Objectives: The aim of this study was to attain insights into common concerns of the general population regarding itch can by analysing itch‐related Internet search behaviour. Methods: Google AdWords Keyword Planner was used to assess search volumes for itch‐related terms in 15 European countries between September 2014 and August 2018. All identified keywords were qualitatively categorized. Itch‐related terms were descriptively analysed and are shown as number of searches/100 000 inhabitants. Results: The search volume for the keyword 'itch' per 100 000 inhabitants was highest in Northern Europe, followed by Eastern, Central and Southern Europe. In 4/15 countries, itch was searched for more often in the autumn/winter months compared to in the spring/summer months. Most itch‐related terms were related to dermatological conditions such as inflammatory skin diseases (e.g. psoriasis, atopic dermatitis), allergic or immunologic conditions (e.g. urticaria), and infectious diseases or infestations (e.g. scabies). In terms of body location, genitoanal itch dominated the searches. Symptoms and signs related to itch, possible non‐dermatological aetiologies, and treatment options were also among the most searched terms. Conclusions: These analyses provided for the first time insights into the search behaviour patterns related to itch across Europe. People from Northern and Eastern Europe are more likely to seek online information regarding itch. Causes for the itch, especially dermatological conditions, and genitoanal itch are the most important concerns for Internet users. This unconventional and inexpensive method identifies medical needs of people beyond the medical setting, including people who do not seek medical consultation. Accordingly, the data could be used to guide public health interventions and manage respective inhabitants' medical needs. [ABSTRACT FROM AUTHOR]

Background: As treatment interruptions occur during psoriasis management in clinical practice, it is important to know the duration of clinical response after treatment withdrawal. Objectives: To report time to and predictors of relapse in patients who were tildrakizumab 100 and 200 mg responders (≥75% improvement in Psoriasis Area and Severity Index, PASI 75) at week 28 re‐randomized to placebo from reSURFACE 1 trial. Methods: Post hoc analysis of adult patients with moderate‐to‐severe plaque psoriasis from a 64‐week phase 3 trial. Relapse was primarily defined as loss of PASI 75 response. Both relapses defined as loss of PASI 90 and loss of absolute PASI < 2 response were included as sensitivity analyses. PASI 75, PASI 90 and PASI < 2 responders re‐randomized to placebo at week 28 and followed up until week 64 were included. The Kaplan–Meier (KM) estimates of the 64‐week relapse rate were calculated. The log‐rank test to compare KM curves from responders to tildrakizumab 100 and 200 mg was used. Independent predictors of relapse were explored. Results: Median time to loss of PASI 75/PASI 90/PASI < 2 response from week 28 was 142/111/112 days with tildrakizumab 100 mg and 172/140/113 days with tildrakizumab 200 mg, respectively (all not significant). Around 20% of patients did not relapse (either maintained a PASI 75 response or were lost to follow‐up) during the 36‐week period. Increase in body mass index (BMI) (hazard ratio, HR [95% confidence interval, CI] for loss of PASI 75 response: 1.0345 [1.0112–1.0582]) and increase in disease duration (HR [95% CI]: 1.0151 [1.0028–1.0275] for loss of PASI 75 response) were associated with an increased risk of relapse, regardless of the relapse definition. Conclusions: When treatment is interrupted, tildrakizumab provides durable maintenance of efficacy with a median time to loss of PASI 75 response of 5–6 months, irrespective of the dose. Interventions on modifiable risk factors for relapse, such as BMI, may improve personalized long‐term psoriasis management. [ABSTRACT FROM AUTHOR]

Introduction: Psoriatic disease is associated with considerable impairment of quality of life (QoL). The PROSE study (NCT02752776) investigated the impact of secukinumab treatment on patient‐reported outcomes (PRO) in patients with moderate to severe psoriasis stratified by their treatment history. Methods: PROSE was a prospective, non‐randomised, multicentre study. Patients were categorized at baseline according to treatment history as naïve [naïve to any systemic therapy (N = 663)], conventional systemic [previously exposed to ≥1 conventional systemic (CS) therapy (N = 673)] and biologics [previously exposed to ≥1 biologic therapy (N = 324)]. QoL PROs, efficacy and safety of secukinumab 300 mg were assessed for a period of 52 weeks. Results: The primary objective was met with 70.8% patients achieving a Dermatology Life Quality Index (DLQI) 0/1 response at Week 16 (naϊve, 74.7%; CS, 71.3%; biologic, 61.7%), with effects sustained up to Week 52. Mean Family DLQI (FDLQI) score decreased from 11.5 at baseline (naϊve, 11.3; CS, 11.4; biologic, 12.1) to 2.5 at Week 16 (naϊve, 2.5; CS, 2.3; biologic: 3.5). Substantial improvements in EuroQoL 5‐Dimension Health Questionnaire, Numeric Rating Scale for pain, itching and scaling, Health Assessment Questionnaire‐Disability Index, Treatment Satisfaction Questionnaire for Medication, and Patient Benefit Index were also observed at Week 16. The QoL gains were associated with substantial improvements in Psoriasis Area and Severity Index and Investigator Global Assessment mod 2011 0/1 response. No meaningful difference was observed in the efficacy or QoL improvements across patient subpopulations. All QoL and efficacy parameter improvements were sustained up to Week 52. Secukinumab treatment was well‐tolerated, and no new safety signals were observed. Conclusion: Secukinumab treatment resulted in complete normalization of QoL in a substantial proportion of psoriasis patients, and their families, regardless of their prior treatment history. [ABSTRACT FROM AUTHOR]

Background: Uraemic pruritus is a common symptom in patients with chronic kidney disease undergoing haemodialysis (HD) treatment. Etiopathogenesis of uraemic pruritus is complex and not fully explained, but there are reports indicating a possible role of peripheral opioid system in its pathomechanism. Objectives: This study was undertaken to analyse the expression of mu‐ and kappa‐opioid receptors in the skin of HD patients with and without uraemic pruritus. Methods: Forty patients suffering from chronic kidney disease, treated with haemodialysis (21 pruritic and 19 non‐pruritic), were included. The expression of mu‐ and kappa‐opioid receptors in their skin was evaluated with immunohistochemistry. Results: The significant (P < 0.02) decrease in kappa‐opioid receptor expression was shown in the skin of pruritic patients in comparison with the skin of those without itch (1.07 ± 0.62 and 1.66 ± 0.85, respectively). Moreover, there was a significant negative correlation between intensity of pruritus and expression of kappa‐opioid receptors (r = −0.63, P = 0.002). There was no difference in the expression of mu‐opioid receptor expression in the skin of pruritic and non‐pruritic HD patients. Conclusions: This study indicates that changes in peripheral opioid system may play an important role in the uraemic itch pathogenesis and that future studies are necessary to fully understand this mechanism. [ABSTRACT FROM AUTHOR]

Background: Chronic nodular prurigo (CNPG) is a condition characterized by chronic itch, a prolonged scratching behaviour and the presence of pruriginous nodules. A comprehensive understanding of this condition, especially regarding its clinical characteristics and impact on quality of life is still lacking. Objectives: Aim of this pan‐European multicentre cross‐sectional study was to establish the clinical profile of CNPG, including its associated burden. Methods: Fifteen centres from 12 European countries recruited CNPG patients presenting at the centre or using the centres' own databases. Patients were asked to complete a questionnaire in paper or electronic format. Demography, current co‐morbidities, underlying disease, itch intensity, additional sensory symptoms, quality of life, highest burden and emotional experience of itch were assessed. Results: A total of 509 patients (210 male, median age: 64 years [52; 72]) were enrolled. Of these, 406 reported itch and CNPG lesions in the previous 7 days and qualified to complete the whole questionnaire. We recorded moderate to severe worst itch intensity scores in the previous 24 h. Scores were higher in patients with lower educational levels and those coming from Eastern or Southern Europe. Most patients experience itch often or always (71%) and report that their everyday life is negatively affected (53%). Itch intensity was considered to be the most burdensome aspect of the disease by 49% of the patients, followed by the visibility of skin lesions (21%) and bleeding of lesions (21%). The majority of patients was unaware of an underlying condition contributing to CNPG (64%), while psychiatric diseases were the conditions most often mentioned in association with CNPG (19%). Conclusions: This multicentre cross‐sectional study shows that itch is the dominant symptom in CNPG and reveals that the profile of the disease is similar throughout Europe. [ABSTRACT FROM AUTHOR]

The European Academy of Dermatology and Venereology (EADV) has started the 'Healthy Skin @ Work' campaign aimed to raise awareness among the public and EU authorities on the frequency and impact of occupational skin diseases (OSDs). The EADV Task Forces (TFs) on Quality of Life and Patient Oriented Outcomes (QoL/PO) and on OSD present their mutual position statement on QoL assessment in OSDs. The EADV TFs recommend the use of the DLQI as a dermatology‐specific instrument and SF‐36 as a generic instrument in health‐related (HR) QoL studies on OSDs. The OSD‐specific questionnaire, LIOD, is not recommended for general use in its present form because of its three months recall period. The EADV TFs discourage the use of non‐validated and of non‐validated modifications of previously validated HRQoL instruments. The EADV TFs wish to encourage research into: the HRQoL impact of OSDs other than occupational contact dermatitis and hand eczema; comparisons between the effects of different treatments and other interventions on HRQoL in OSDs; and into the HRQoL impairment of patients with OSDs from different countries, and with different provoking factors, to predict if the results of successful therapeutic and educational interventions may be generalized across countries and between occupations. [ABSTRACT FROM AUTHOR]

The pandemic of COVID‐19 is a global challenge for health care, and dermatologists are not standing apart from trying to meet this challenge. The European Academy of Dermatology and Venereology (EADV) has collected recommendations from its Task Forces (TFs) related to COVID‐19. The Journal of the EADV has established a COVID‐19 Special Forum giving free access to related articles. The psychosocial effects of the pandemic, an increase in contact dermatitis and several other skin diseases because of stress, disinfectants and protective equipment use, especially in healthcare workers, the temporary limited access to dermatologic care, the dilemma whether or not to pause immunosuppressive therapy, and, finally, the occurrence of skin lesions in patients infected by COVID‐19 all contribute to significant quality of life (QoL) impairment. Here, we present detailed recommendations of the EADV TF on QoL and patient‐oriented outcomes on how to improve QoL in dermatologic patients during the COVID‐19 pandemic for several different groups of patients and for the general population. [ABSTRACT FROM AUTHOR]

The special interest group on sensitive skin of the International Forum for the Study of Itch previously defined sensitive skin as a syndrome defined by the occurrence of unpleasant sensations (stinging, burning, pain, pruritus and tingling sensations) in response to stimuli that normally should not provoke such sensations. This additional paper focuses on the pathophysiology and the management of sensitive skin. Sensitive skin is not an immunological disorder but is related to alterations of the skin nervous system. Skin barrier abnormalities are frequently associated, but there is no cause and direct relationship. Further studies are needed to better understand the pathophysiology of sensitive skin – as well as the inducing factors. Avoidance of possible triggering factors and the use of well‐tolerated cosmetics, especially those containing inhibitors of unpleasant sensations, might be suggested for patients with sensitive skin. The role of psychosocial factors, such as stress or negative expectations, might be relevant for subgroups of patients. To date, there is no clinical trial supporting the use of topical or systemic drugs in sensitive skin. The published data are not sufficient to reach a consensus on sensitive skin management. In general, patients with sensitive skin require a personalized approach, taking into account various biomedical, neural and psychosocial factors affecting sensitive skin. [ABSTRACT FROM AUTHOR]

Background: Psoriasis is a chronic inflammatory skin disease associated with quality of life (QoL) impairment. BRIDGE was a randomized, double‐blind, phase III study comparing the efficacy and safety of dimethylfumarate (DMF) with a fixed combination of fumaric acid esters (FAE) or placebo for the treatment of moderate‐to‐severe psoriasis. Objectives: This post hoc analysis investigated treatment effect on QoL overall and by patient subgroups categorized by disease severity. Week 8 efficacy responses were also investigated as possible predictors of Week 16 Dermatology Life Quality Index (DLQI) outcomes. Methods: Patients were randomized to receive a maximum daily dose of 720 mg of DMF, FAE (gradual up‐titration) or placebo for 16 weeks. Psoriasis Area Severity Index, Body Surface Area, Physician's Global Assessment and DLQI were assessed at baseline, Weeks 8 and 16. DLQI 0‐1 indicated 'no effect on patient life'. Associations between baseline severity, Week 16 DLQI and Week 8 efficacy (as observed cases) were also examined. Results: At baseline, 671 patients were included in the full analysis set (267 randomized to DMF, 273 to FAE and 131 to placebo). DMF was superior to placebo (P < 0.001) and not significantly different to FAE regarding Week 16 DLQI outcomes (P > 0.05). Baseline disease severity did not impact DLQI outcomes at Week 16. In DMF‐ and FAE‐treated patients, Week 8 PASI 50/75 responders reported better DLQI responses at Week 16 vs non‐responders (P < 0.05). Week 8 PASI ≤ 3 and/or PGA 0‐1 responders were also more likely to report DLQI 0‐1 at Week 16 vs non‐responders (P < 0.05). Conclusion: Dimethylfumarate significantly improved DLQI outcomes vs. placebo and was not affected by baseline disease severity. Efficacy responses (PASI 50/75, PASI ≤3 and PGA 0‐1) as early as Week 8 were predictive of QoL outcomes at Week 16 in DMF‐ and FAE‐treated patients. [ABSTRACT FROM AUTHOR]

Background: Itch is an integral part of clinical picture of superficial dermatophytoses which constitute a common and growing problem in India. Objectives: The study aimed to evaluate the prevalence, intensity and clinical characteristics of itch in superficial dermatophytosis. Methods: The data concerning disease history and clinical type of dermatophytosis were obtained. The presence and various characteristics of itch were documented. Numerical Rating Scale (NRS) was utilized to assess the worst intensity of itch during the last 3 days and during the course of the disease. 4‐Item Itch Questionnaire was utilized to assess itch extent, intensity, frequency and associated sleep impairment, while quality of life (QoL) impairment was assessed via Dermatology Life Quality Index. Results: Ninety‐nine patients with direct microscopic confirmation of dermatophytosis were included in the study. In 46.5% of subjects, the coexistence of tinea corporis and tinea cruris was noted, followed by tinea cruris (25.2%) and tinea corporis (13.1%). The majority of patients reported itch in the last 3 days (99%) and complained of itch limited to skin lesions (89.9%). According to NRS, the mean intensity of worst itch in the last 3 days was 6.8 ± 1.8 points. Severe and very severe itch was reported by 74.7% of patients. Itch was an isolated sensation in 34.3% of subjects, while 46.9% reported associated burning sensation. Itch was frequently exacerbated by sweating, hot temperature and wearing tight clothes. Difficulties in falling asleep and sleep awakenings were reported by 34.3% and 54.6% of subjects, respectively. Itch negatively influenced the well‐being of patients and its intensity correlated with QoL impairment. Conclusions: Itch is an important symptom in superficial dermatophytoses and is associated with negative impact on sleep and carries a significant psychosocial burden. Acknowledging its presence is necessary in a holistic approach to these patients. [ABSTRACT FROM AUTHOR]

Summary: Background: Hidradenitis suppurativa (HS), also referred to as acne inversa, is a debilitating skin disease characterized by inflammatory nodules, chronic abscesses and tunnels (fistulae and sinuses). The association with pilonidal sinus disease (PSD) is frequently reported but not well documented. Objectives: To determine the prevalence and characteristics of inflammatory skin lesions located in the intergluteal fold (IGF) of patients with HS. Methods: This was an international multicentre retrospective cross‐sectional study based on data collection from a large cohort of patients with HS with and without histopathology. Results From a total of 2465 patients with HS included in the study, 661 (27%) reported lesions in the IGF. These patients were significantly more often smokers and had more severe HS. Of the 238 patients with an available clinical diagnosis, intergluteal‐HS (IG‐HS) was diagnosed in 52 patients (22%) and PSD was diagnosed in 186 patients (78%). IG‐HS was associated with the localization of HS in the proximity of the IGF, including the buttocks, genitals and the anus. There was a possibility of misclassification bias in this study as a clinical/image‐based diagnosis or histopathology of the IGF lesions was not always available. Conclusions: The high prevalence of PSD suggests a strong link between both entities. Therefore, it may be useful to identify common pathophysiological mechanisms and develop common therapeutic strategies. What's already known about this topic? The occurrence of pilonidal sinus disease has not been clearly reported among patients with hidradenitis suppurativa/acne inversa. What does this study add? This is the first study that investigated the prevalence of pilonidal sinus disease among a large cohort of patients and identified the patient characteristics.Risk factors that might help to improve the management of patients were identified. Respond to this article Linked Comment: Frew and Navrazhina. Br J Dermatol 2019; 181:1121. [ABSTRACT FROM AUTHOR]

This paper is organized jointly by the European Academy of Dermatology and Venereology (EADV) Task Force (TF) on Quality of Life (QoL) and Patient‐Oriented Outcomes and the EADV TF on acne, rosacea and hidradenitis suppurativa (ARHS). The purpose of this paper was to present current knowledge about QoL assessment in HS, including data on HS‐specific health‐related (HR) QoL instruments and HRQoL changes in clinical trials, and to make practical recommendations concerning the assessment of QoL in people with HS. HS results in significant quimp that is higher than in most other chronic skin diseases. HS impact in published studies was assessed predominantly (84% of studies) by the Dermatology Life Quality Index (DLQI). There is a lack of high‐quality clinical trials in HS patients where HRQoL instruments have been used as outcome measures. One double‐blind randomized placebo‐controlled trial on infliximab with low number of participants reported significantly better HRQoL improvement in the treatment group than in the placebo group. Well‐designed clinical studies in HS patients to compare different treatment methods, including surgical methods and assessing long‐term effects, are needed. Because of lack of sufficient validation, the Task Forces are not at present able to recommend existing HS‐specific HRQoL instruments for use in clinical studies. The EADV TFs recommend the dermatology‐specific DLQI questionnaire for use in HS patients. The EADV TFs encourage the further development, validation and use of other HS‐specific, dermatology‐specific and generic instruments but such use should be based on the principles presented in the previous publications of the EADV TF on QoL and Patient‐Oriented Outcomes. [ABSTRACT FROM AUTHOR]

Background: The first dermatology‐specific proxy health‐related quality of life (HRQoL) instrument for children 0–4 years old with skin diseases, the Infants and Toddlers Dermatology Quality of Life (InToDermQoL), was recently developed. In order to avoid the problem of cross‐cultural inequivalence focus groups work and pilot tests were organized simultaneously in all national centres of the project. The InToDermQoL showed good comprehensibility, clarity and acceptance. Objective: To validate the InToDermQoL questionnaire during international field tests. Methods: Internal consistency, test–retest reliability, convergent and discriminant validity of the InToDermQoL questionnaire were checked during international field tests. Results: Parents of 473 children with skin diseases filled in the national language versions of the InToDermQoL questionnaire. All three age‐specific versions of the InToDermQoL questionnaire with 10, 12 and 15 items, respectively, showed high internal consistency (Cronbach's α 0.90–0.93), good test–retest reliability (correlation coefficients > 0.9), significant correlations with the most widely used atopic dermatitis‐specific proxy instrument, the Infants Dermatitis Quality of Life Index (correlation coefficients 0.68–0.79). The InToDermQoL versions for children <3 years old well correlated with the atopic dermatis severity measure Scoring of Atopic Dermatitis (correlation coefficients 0.66 and 0.86 for 10 and 12 items versions, respectively). The InToDermQoL questionnaire discriminated well among different diagnoses and disease severity levels. Conclusion: Our field tests confirmed internal consistency, test–retest reliability, convergent and discriminant validity of the InToDermQoL questionnaire. Development and validation of the InToDermQoL questionnaire make it possible to assess dermatology‐specific aspects of HRQoL in youngest children with skin diseases. There are many reasons to assess HRQoL in dermatologic clinical practice, and we hope that our new instrument will be used internationally in paediatric dermatology for research and practical needs. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented regarding the impact of uremic pruritus (UP) on the health and quality of life (QoL) of hemodialysis (HD) patients.

Summary: Background: The relevance of granulocyte–macrophage colony‐stimulating factor (GM‐CSF) in the management of psoriasis has not been studied previously. GM‐CSF is important in the initiation and maintenance of chronic inflammatory processes. Objectives: To investigate the clinical use of GM‐CSF neutralization by evaluating the efficacy and safety of namilumab (AMG203), a monoclonal antibody GM‐CSF inhibitor, in patients with moderate‐to‐severe plaque psoriasis. Methods: A phase II, multicentre, randomized, double‐blind, placebo‐controlled, parallel‐group, dose‐finding, proof‐of‐concept study (NEPTUNE) was conducted. Four doses of namilumab (20, 50, 80 and 150 mg, via subcutaneous injection) were compared with placebo. Assessment of the primary end point – the proportion of patients achieving ≥ 75% reduction in Psoriasis Area and Severity Index (PASI 75 treatment response) – was performed at week 12. Exploratory investigation at the tissue level was conducted in a subset of the overall study population. The trial was registered with the number NCT02129777. Results: In total, 122 patients were enrolled and 106 (86·9%) completed the double‐blind treatment; 16 (13·1%) prematurely discontinued study medication. Serum concentration–time profiles were as expected for subcutaneous delivery of an IgG1 monoclonal antibody, and exposure increased proportionally with dose elevation. The number of patients showing PASI 75 treatment response at week 12 was low in all groups; no significant difference was recorded in this end point between placebo and any namilumab group. Similar outcomes were recorded for other clinical study end points. Moreover, no significant treatment‐related changes from baseline were observed in laboratory investigations of cell types or subpopulations, or cytokines relevant to inflammatory pathways in psoriasis. Conclusions: GM‐CSF blockade is not critical for suppression of key inflammatory pathways underlying psoriasis. What's already known about this topic? Blockade of granulocyte–macrophage colony‐stimulating factor (GM‐CSF) signalling is effective in rheumatoid arthritis.Potential relevance for psoriasis has been indicated by the presence of GM‐CSF in psoriasis‐related skin blister fluid and the serum of patients with psoriasis, and also by elevated expression in psoriatic skin lesions. What does this study add? This is the first clinical investigation into the efficacy and safety of an anti‐GM‐CSF antibody in plaque psoriasis.This study provides no evidence of benefit for GM‐CSF neutralization in the treatment of plaque psoriasis.Safety profiles were comparable in the placebo and anti‐GM‐CSF treatment groups, and no incidences of pulmonary alveolar proteinosis or clinically significant changes in lung function were recorded throughout the short‐term duration of study treatment.Overall, the findings point to key differences in the role of GM‐CSF in the pathogeneses of psoriasis and rheumatoid arthritis. Linked Comment: Crowley. Br J Dermatol 2019; 180:1286–1287. Plain language summary available online Respond to this article [ABSTRACT FROM AUTHOR]

Background: Atopic dermatitis (AD) is a common inflammatory skin disease of complex aetiology, with interactions between susceptibility genes and environmental factors. We have previously described a protective effect of the KIR2DS1 gene encoding the natural killer cell receptor, whose ligands are HLA‐C molecules. Here, we found an association of HLA‐C*05:01 allele with AD. KIR‐HLA‐C interactions are affected by peptides presented by HLA‐C. The generation of these peptides is strongly influenced by endoplasmic reticulum aminopeptidases 1 and 2 (ERAP1 and ERAP2). Expression and activity of ERAP molecules depend on the polymorphisms of their genes. Objective: Possible associations of several single nucleotide polymorphisms (SNPs) in the ERAP1 and ERAP2 genes with susceptibility to AD. Methods: Peripheral blood DNA isolation from 318 patients and 549 controls. PCR‐SSO or PCR‐SSP for HLA‐C typing; TaqMan Genotyping Assay for ERAP typing. Results: Only one SNP in the ERAP1 gene, rs26618T>C, causing the amino acid change Ile276Met, had an association with AD. To gain insight on the functional role of this SNP, we produced recombinant variants differing only at position 276 (Ile or Met) and tested their aminopeptidase activity against a N‐terminally extended precursor LIVDRPVTLV of the HLA‐C*05:01 epitope IVDRPVTLV. Both ERAP1 variants were able to efficiently generate the epitope, although the 276Ile allotype was able to do this about 50% faster. Furthermore, both variants were quite inefficient in further degradation of the mature epitope. Finally, we found that the effect of 276Met on susceptibility to AD was seen only in KIR2DS1‐negative individuals, not protected by this KIR. Conclusion: Associations of HLA‐C*05:01 allele and rs26618T>C (Ile276Met) ERAP1 polymorphism with AD, and a significant difference between these two ERAP1 variants in their ability to generate an epitope for the HLA‐C*05:01 molecule was found. [ABSTRACT FROM AUTHOR]

The European Academy of Dermatology and Venereology (EADV) Task Forces (TFs) on Quality of Life (QoL) and Patient Oriented Outcomes, Melanoma and Non‐Melanoma Skin Cancer (NMSC) present a review of the literature and position statement on health‐related (HR) QoL assessment in skin cancer patients. A literature search was carried out to identify publications since 1980 that included information about the impact of SC on QoL. Generic, dermatology‐specific, cancer‐specific, SC‐specific, facial SC‐specific, NMSC‐specific, basal cell carcinoma‐specific and melanoma‐specific QoL questionnaires have been used to assess HRQoL in SC patients. HRQoL was assessed in the context of creation and validation of the HRQoL instruments, clinical trials, comparison of QoL in SC and other cancers, other diseases or controls, HRQoL assessment after treatment, comorbidities, behaviour modification, predictors of QoL and survival, supportive care needs, coping strategies and fear of cancer recurrence. The most widely used instruments for HRQoL assessment in SC patients are the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ‐C30), the Functional Assessment of Cancer Therapy‐Melanoma (FACT‐M), Skin Cancer Index (SCI), Short Form 36 Item Health Survey (SF‐36) and the Dermatology Life Quality Index (DLQI). The TFs recommend the use of the cancer‐specific EORTC QLQ‐C30, especially in late stages of disease, and the melanoma‐specific FACT‐M and SC‐specific SCI questionnaires. These instruments have been well validated and used in several studies. Other HRQoL instruments, also with good basic validation, are not currently recommended because the experience of their use is too limited. Dermatology‐specific HRQoL instruments can be used to assess the impact of skin‐related problems in SC. The TFs encourage further studies to validate HRQoL instruments for use in different stages of SC, in order to allow more detailed practical recommendations on HRQoL assessment in SC. [ABSTRACT FROM AUTHOR]

Background: Superficial fungal infections are common. It is important to confirm the clinical diagnosis by mycological laboratory methods before initiating systemic antifungal treatment, especially as antifungal sensitivity and in vitro susceptibility may differ between different genera and species. For many years, the gold standard for diagnosis of superficial fungal infections has been direct fungal detection in the clinical specimen (microscopy) supplemented by culturing. Lately, newer molecular based methods for fungal identification have been developed. Objective: This study was initiated to focus on the current usage of mycological diagnostics for superficial fungal infections by dermatologists. It was designed to investigate whether it was necessary to differentiate between initial diagnostic tests and those used at treatment follow‐up in specific superficial fungal infections. Methods: An online questionnaire was distributed among members of the EADV mycology Task Force and other dermatologists with a special interest in mycology and nail disease. Results: The survey was distributed to 62 dermatologists of whom 38 (61%) completed the whole survey, 7 (11%) partially completed and 17 (27%) did not respond. Nearly, all respondents (82–100%) said that ideally they would use the result of direct microscopy (or histology) combined with a genus/species directed treatment of onychomycosis, dermatophytosis, Candida‐ and Malassezia‐related infections. The majority of the dermatologists used a combination of clinical assessment and direct microscopy for treatment assessment and the viability of the fungus was considered more important at this visit than when initiating the treatment. Molecular based methods were not available for all responders. Conclusion: The available diagnostic methods are heterogeneous and their usage differs between different practices as well as between countries. The survey confirmed that dermatologists find it important to make a mycological diagnosis, particularly prior to starting oral antifungal treatment in order to confirm the diagnose and target the therapy according to genus and species. [ABSTRACT FROM AUTHOR]

Background: Chronic prurigo (CPG) is a distinct disease characterized by chronic pruritus, history and/or signs of prolonged scratching and multiple pruriginous lesions. It may present with various clinical manifestations, including papules, nodules, plaques or umbilicated lesions. Some patients with chronic pruritus show pruriginous linear and scaring scratch lesions (LSSL) and it is unclear whether these lesions belong to the spectrum of CPG. Objective: To achieve a consensus on the classification of pruriginous LSSL and establish criteria to differentiate them from similar appearing conditions of different nature. Methods: Members of the Task Force Pruritus (TFP) of the European Academy of Dermatology and Venereology participated in the consensus conference, discussing representative clinical cases. Using the Delphi method, consensus was reached when ≥75% of members agreed on a statement. Results: Twenty‐one members of the TFP with voting rights participated in the meeting. It was consented that LSSL occurs due to chronic pruritus and prolonged scratching, and share common pathophysiological mechanisms with CPG. LSSL were thus considered as belonging to the spectrum of CPG and the term 'linear prurigo' was chosen to describe this manifestation. Conclusion: Considering linear prurigo as belonging to the spectrum of CPG has important clinical implications, since both the diagnostic and therapeutic approach of these patients should be performed as recommended for CPG. Importantly, linear prurigo should be differentiated from self‐inflicted skin lesions as factitious disorders or skin picking syndromes. In the latter, artificial manipulation rather than pruritus itself leads to the development of cutaneous lesions, which can show clinical similarities to linear prurigo. [ABSTRACT FROM AUTHOR]

Background: Chronic pruritus (CP) is a frequently occurring symptom in inflammatory dermatoses, causing a high burden and limitations to health‐related quality of life (HRQoL). Objective: The ItchyQoL was developed to assess the impairment to HRQoL in patients with CP. However, it has only been validated in English and German. Here, we report the validation in several languages across Europe. Methods: After professional translation, the versions of ItchyQoL were digitized for use as a tablet application. Validation was performed in clinics for dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. Results: Five hundred and thirty‐five patients with either contact dermatitis, chronic prurigo – nodular type, psoriasis vulgaris, lichen planus or mycosis fungoides/Sézary syndrome and with CP ≥ 3 on the numerical rating scale were included. ItchyQoL showed a high level of consistency (Cronbach's‐α, all: 0.95) and test‐retest reliability (intraclass correlation: 0.91). It strongly correlated with the Dermatology Life Quality Index (r = 0.72, P < 0.001) and moderately correlated with itch intensity scales in the study population (visual analogue scale r = 0.46; numerical rating scale r = 0.51; verbal rating scale r = 0.51, for all: P < 0.001). Conclusion: ItchyQoL is now also validated in French, Italian, Polish, Russian, Spanish and Turkish and can be used in clinical trials in countries speaking these languages. [ABSTRACT FROM AUTHOR]

Background: Psoriasis has been shown to increase cardiovascular risk, and a contributor to this might be enhanced myocardial fibrosis promoted by the disease‐associated pro‐inflammatory milieu. Objective: We sought to investigate the relationship of galectin‐3 (Gal‐3) – a recognized mediator of fibrosis with inflammatory activation and left ventricular (LV) systolic and diastolic function in patients with psoriasis. Methods: We enrolled 102 psoriatic patients (mean age: 52.5 ± 12.6 years). Sixty‐five age‐ and sex‐matched healthy subjects served as controls. Echocardiographic assessment of myocardial function included estimation of LV longitudinal systolic deformation (GLS) and diastolic indices: tissue e′ velocity and E/e′ ratio. Laboratory measurements encompassed blood Gal‐3, creatinine, glucose, insulin, CRP and erythrocyte sedimentation rate (ESR). Results: Patients with psoriasis were characterized by elevated Gal‐3 (12.3 [9.3–13.4] vs. 6.3 [5.5–9.4] ng/mL in healthy controls, P < 0.001), ESR (17.0 [11.0–29.0] vs. 8.5 [6.0–13.0] mm, respectively, P < 0.001) and CRP (3.1 [1.7–10.6] vs. 1.9 [1.5–4.0] mg/L, respectively, P < 0.001), and reduced GLS (19.9 ± 3.7 vs. 22.0 ± 3.0%, respectively, P < 0.001). Progressive deterioration of GLS was demonstrated across Gal‐3 tertiles. Significant associations between GLS and age (beta = −0.21, P < 0.04), Gal‐3 (beta = −0.27, P < 0.01), CRP (beta = −0.22, P < 0.03), ESR (beta = −0.25, P < 0.01), waist circumference (beta = −0.22, P < 0.03) and waist‐to‐hip ratio (beta = −0.20, P < 0.05) were found. Stepwise multiple regression analysis revealed that the independent determinants of GLS in psoriatic patients were Gal‐3 (beta = −0.24, P < 0.01) and ESR (beta = −0.21, P < 0.03). Regression‐based mediation analysis demonstrated that the relationship between ESR and GLS was partially mediated by Gal‐3. Conclusions: Subclinical left ventricular systolic dysfunction in psoriasis, as evidenced by reduced GLS, is linked with the inflammatory upregulation, and enhanced profibrotic activity (as reflected by elevated serum Gal‐3) may be involved in this process. These putative mechanisms may be responsible for the observed higher incidence of heart failure in this disease condition and should be considered as a potential target for preventive and therapeutic measures. [ABSTRACT FROM AUTHOR]

Dear Editor, Core outcome domains represent a major need in hidradenitis suppurativa/acne inversa (HS) as reliable disease staging systems and outcome measurement instruments (OMIs). The IAR using IHS4 and HS-PGA was very good, regarding both the capacity to distinguish the patient's stage and the reproducibility of the individual patient assessment. Based on the results of this study, IHS4 in particular, but also HS-PGA, can be recommended for staging of patients with HS. [Extracted from the article]

Introduction Overweight is a well-established risk factor for hidradenitis suppurativa (HS). In this cross-sectional study, we compare HS patients with a high body mass index (BMI) with HS patients with a low BMI to investigate differences in disease characteristics. Materials and method Patients were recruited from 17 dermatological centres from four continents. A total of 246 patients with a BMI below 25 were compared to 205 patients with a BMI of above 35. Results Patients with a high BMI suffered more severe disease (Hurley, physician global assessment, number of areas affected and patient-reported severity (PRS), P < 0.001 for all). There was no difference in smoking (P = 0.783) nor in family history (P = 0.088). In both low and high BMI patients, early onset of HS was a predictor of positive family history (P < 0.001, for each). For low BMI patients, an increase in BMI significantly increased PRS (P < 0.001). For patients with a high BMI, number of pack-years significantly increased PRS (P = 0.001). Cluster analysis of eruption patterns was location specific for low BMI patients but severity specific for high BMI patients. Discussion Patients with a low and high BMI could represent two clinically different subtypes. We suggest a non-linear relationship between BMI and impact of HS. As patients go from a low BMI patient to a high BMI patient (or from high to low), eruption patterns and risk factors may change. [ABSTRACT FROM AUTHOR]

Acne causes profound negative psychological and social effects on the quality of life (QoL) of patients. The European Dermatology Forum S3-Guideline for the Treatment of Acne recommended adopting a QoL measure as an integral part of acne management. Because of constantly growing interest in health-related QoL assessment in acne and because of the high impact of acne on patients’ lives, the European Academy of Dermatology and Venereology Task Force on QoL and Patient Oriented Outcomes and the Task Force on Acne, Rosacea and Hidradenitis Suppurativa have documented the QoL instruments that have been used in acne patients, with information on validation, purposes of their usage, description of common limitations and mistakes in their usage and overall recommendations. [ABSTRACT FROM AUTHOR]

Background A validated tool for the dynamic severity assessment of hidradenitis suppurativa/acne inversa ( HS) is lacking. Objectives To develop and validate a novel dynamic scoring system to assess the severity of HS. Methods A Delphi voting procedure was conducted among the members of the European Hidradenitis Suppurativa Foundation ( EHSF) to achieve consensus towards an initial HS Severity Score System ( HS4). Strengths and weaknesses of HS4 were examined by a multicentre prospective study. Multivariate logistic regression, discriminant analysis and receiver operating characteristic curves, as well as examination for correlation (Spearman's rho) and agreement (Cohen's kappa) with existing scores, were engaged to recognize the variables for a new International HS4 ( IHS4) that was established by a second Delphi round. Results Consensus HS4 was based on number of skin lesions, number of skin areas involved and Dermatology Life Quality Index ( DLQI), and was evaluated by a sample of 236 patients from 11 centres. Subsequently, a multivariate regression model calculated adjusted odds ratios for several clinical signs. Nodules, abscesses and draining tunnels resulted as the scoring variables. Three candidate scores were presented to the second Delphi round. The resulting IHS4 score is arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Cohen's kappa was fair (κ = 0·32) compared with Hurley classification, and moderate (κ = 0·49) compared with Expert Opinion. Correlation was good (ρ > 0·6) with Hurley classification, Expert Opinion, Physician's Global Assessment and Modified Sartorius score, and moderate for DLQI (ρ = 0·36). Conclusions The novel IHS4 is a validated tool to dynamically assess HS severity and can be used both in real-life and the clinical trials setting. [ABSTRACT FROM AUTHOR]

The patient is the centre of a web of relationships, and the impact of his/her disease on family members and caregivers must be taken into account. The aim of this study was to identify the specific instruments that measure the impact of a dermatological disease on the quality of life (QoL) of family members, by performing a systematic search of the literature. Fifteen papers were identified, describing the creation and validation of nine instruments. Four of them concerned atopic dermatitis (Dermatitis Family Index, DFI; Parents' Index QoL Atopic Dermatitis, PiQoL- AD; QoL in primary caregivers of children with atopic dermatitis, QPCAD; Childhood Atopic Dermatitis Impact Scale, CADIS), two measured the impact of psoriasis in family members (Psoriasis Family Index, PFI; FamilyPso), one the impact of epidermolysis bullosa (Epidermolysis Bullosa Burden of Disease, EB-BoD), one of ichthyosis (Family Burden Ichthyosis, FBI), and one was generic for dermatological conditions (Family Dermatology Life Quality Index, FDLQI). The European Academy of Dermatology and Venereology quality of life taskforce recommends that the impact of a skin disease on family and caregivers should be measured as part of any thorough evaluation of the burden of a disease. Guidelines are given to choose the most appropriate instruments. [ABSTRACT FROM AUTHOR]

Background Generic instruments measuring health-related quality of life (HRQoL), like EQ5D™, enable comparison of skin diseases with healthy populations and nondermatological medical conditions, as well as calculation of utility data. Objectives To measure HRQoL in patients with common skin diseases and healthy controls across Europe using the EQ5D. Methods This multicentre observational cross-sectional study was conducted in 13 European countries. Each dermatology clinic recruited at least 250 consecutive adult outpatients to complete questionnaires, including the EQ5D. Results There were 5369 participants (4010 patients and 1359 controls). Mean ± SD self-rated health state reported by patients was 69·9 ± 19·7; for controls it was 82·2 ± 15·5. When adjusted for confounding factors, including comorbidity, mean patient EQ visual analogue scores were 10·5 points lower than for controls (standardized β = −0·23). Odds ratio with 95% confidence interval for impairment in all five dimensions of EQ5D adjusted for confounders was doubled for patients compared with controls. Patients with hidradenitis suppurativa (HS), blistering conditions, leg ulcers, psoriasis and eczemas had the highest risk for reduction in HRQoL in most dimensions (2-10-fold). Data on differences of impairment by dimensions offer new insights. Conclusions This study confirms the large impact skin conditions have on patients' well-being, differentiating between aspects of HRQoL. Patients with HS, blistering diseases, leg ulcers, infections and most chronic skin diseases reported reduced HRQoL compared with patients with chronic obstructive lung disease, diabetes mellitus, cardiovascular disease and cancers. These findings are important in the prioritization of resource allocation between medical fields and within dermatological subspecialities. [ABSTRACT FROM AUTHOR]

Cutaneous lupus erythematosus ( CLE) is a rare inflammatory autoimmune disease with heterogeneous clinical manifestations. To date, no therapeutic agents have been licensed specifically for patients with this disease entity, and topical and systemic drugs are mostly used 'off-label'. The aim of the present guideline was to achieve a broad consensus on treatment strategies for patients with CLE by a European subcommittee, guided by the European Dermatology Forum ( EDF) and supported by the European Academy of Dermatology and Venereology ( EADV). In total, 16 European participants were included in this project and agreed on all recommendations. Topical corticosteroids remain the mainstay of treatment for localized CLE, and further topical agents, such as calcineurin inhibitors, are listed as alternative first-line or second-line topical therapeutic option. Antimalarials are recommended as first-line and long-term systemic treatment in all CLE patients with severe and/or widespread skin lesions, particularly in patients with a high risk of scarring and/or the development of systemic disease. In addition to antimalarials, systemic corticosteroids are recommended as first-line treatment in highly active and/or severe CLE. Second- and third-line systemic treatments include methotrexate, retinoids, dapsone and mycophenolate mofetil or mycophenolate acid, respectively. Thalidomide should only be used in selected therapy-refractory CLE patients, preferably in addition to antimalarials. Several new therapeutic options, such as B-cell- or interferon α-targeted agents, need to be further evaluated in clinical trials to assess their efficacy and safety in the treatment of patients with CLE. [ABSTRACT FROM AUTHOR]

Background Many current guidelines provide detailed evidence-based recommendations for acne treatment. Objective To create consensus-based, simple, easy-to-use algorithms for clinical acne treatment in daily office-based practice and to provide checklists to assist in determining why a patient may not have responded to treatment and what action to take. Methods Existing treatment guidelines and consensus papers were reviewed. The information in them was extracted and simplified according to daily clinical practice needs using a consensus-based approach and based on the authors' clinical expertise. Results As outcomes, separate simple algorithms are presented for the treatment of predominant comedonal, predominant papulopustular and nodular/conglobate acne. Patients with predominant comedonal acne should initially be treated with a topical retinoid, azelaic acid or salicylic acid. Fixed combination topicals are recommended for patients with predominant papulopustular acne with treatment tailored according to the severity of disease. Treatment recommendations for nodular/conglobate acne include oral isotretinoin or fixed combinations plus oral antibiotics in men, and these options may be supplemented with oral anti-androgenic hormonal therapy in women. Further decisions regarding treatment responses should be evaluated 8 weeks after treatment initiation in patients with predominant comedonal or papulopustular acne and 12 weeks after in those with nodular/conglobate acne. Maintenance therapy with a topical retinoid or azelaic acid should be commenced once a patient is clear or almost clear of their acne to prevent the disease from recurring. The principal explanations for lack of treatment response fall into 5 main categories: disease progression, non-drug-related reasons, drug-related reasons, poor adherence, and adverse events. Conclusion This practical guide provides dermatologists with treatment algorithms adapted to different clinical features of acne which are simple and easy to use in daily clinical practice. The checklists to establish the causes for a lack of treatment response and subsequent action to take will facilitate successful acne management. [ABSTRACT FROM AUTHOR]

The article discusses the results of a study aimed at exploring the delay in diagnosis for patients with hidradenitis suppurativa (HS) on an international level. Findings reveal that patients with HS have a longer delay in diagnosis than patients with psoriasis and that the relationship between the clinical severity and duration of delay is impacted by the evolution of the disease.

Hidradenitis suppurativa/acne inversa ( HS) is a chronic, inflammatory, recurrent, debilitating skin disease of the hair follicle that usually presents after puberty with painful, deep-seated, inflamed lesions in the apocrine gland-bearing areas of the body, most commonly the axillae, inguinal and anogenital regions. A mean disease incidence of 6.0 per 100 000 person-years and an average prevalence of 1% has been reported in Europe. HS has the highest impact on patients' quality of life among all assessed dermatological diseases. HS is associated with a variety of concomitant and secondary diseases, such as obesity, metabolic syndrome, inflammatory bowel disease, e.g. Crohn's disease, spondyloarthropathy, follicular occlusion syndrome and other hyperergic diseases. The central pathogenic event in HS is believed to be the occlusion of the upper part of the hair follicle leading to a perifollicular lympho-histiocytic inflammation. A highly significant association between the prevalence of HS and current smoking (Odds ratio 12.55) and overweight (Odds ratio 1.1 for each body mass index unit) has been documented. The European S1 HS guideline suggests that the disease should be treated based on its individual subjective impact and objective severity. Locally recurring lesions can be treated by classical surgery or LASER techniques, whereas medical treatment either as monotherapy or in combination with radical surgery is more appropriate for widely spread lesions. Medical therapy may include antibiotics (clindamycin plus rifampicine, tetracyclines), acitretin and biologics (adalimumab, infliximab). A Hurley severity grade-relevant treatment of HS is recommended by the expert group following a treatment algorithm. Adjuvant measurements, such as pain management, treatment of superinfections, weight loss and tobacco abstinence have to be considered. [ABSTRACT FROM AUTHOR]

Background In recent years it has been controversially discussed in the literature if smoking is associated with the activity of cutaneous lupus erythematosus ( CLE) and the efficacy of antimalarial agents. Objectives To investigate the influence of smoking on disease severity and antimalarial treatment in patients with CLE using the Core Set Questionnaire of the European Society of Cutaneous Lupus Erythematosus ( EUSCLE). Methods A total of 1002 patients (768 female, 234 male) with different CLE subtypes were included in this cross-sectional study, which was performed in 14 different countries. Smoking behaviour was assessed by the EUSCLE Core Set Questionnaire in 838 patients and statistically analysed using an SPSS database. The results were correlated with the Cutaneous Lupus Erythematosus Disease Area and Severity Index ( CLASI) and the efficacy of antimalarial treatment. Results A high percentage (87·2%) of the 499 patients with CLE, who have ever smoked, had already smoked at the date of their first diagnosis. Patients with intermittent CLE have ever smoked significantly more often than patients with subacute CLE ( P < 0·05) and chronic CLE ( P < 0·05). The total CLASI activity and damage score of patients with CLE was 6·6 ± 7·1 and 2·6 ± 4·3, respectively, and was higher in patients who have ever smoked than in nonsmokers. Antimalarial treatment was successful in 84·3% of cases, with a significantly higher efficacy in nonsmokers than in patients with CLE who have ever smoked ( P < 0·05). Conclusions This analysis of a multicentre study population of 838 patients with CLE assessed by the EUSCLE Core Set Questionnaire confirms that smoking negatively influences CLE disease severity and the efficacy of antimalarial treatment. [ABSTRACT FROM AUTHOR]

The patient in this manuscript has given written informed consent to the publication of his case details. We suspected that scrotal ulcers might be related to axitinib therapy; however, the patient refused to discontinue this treatment. Although scrotal cutaneous adverse events had been described as related to other agents in the same class,4-7 no scrotal ulcers have been reported during axitinib treatment so far.7 The exact mechanism of the scrotal ulcer induction remains unclear. [Extracted from the article]