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Background: Phototherapy is used to treat atopic dermatitis (AD). Evidence for its efficacy, impact on quality of life, cost‐effectiveness and short‐ and long‐term safety with real‐life usage is weak. Objectives: We established a taskforce to examine how phototherapy is currently being used as a treatment for AD across the United Kingdom and Europe to inform our understanding and guide future research into management of patients with AD using UV‐based phototherapies. Methods: An anonymous electronic multiple‐response survey exploring phototherapy prescribing practices and experience of phototherapy modalities was developed by the study authors and sent to members of phototherapy networks from the United Kingdom and Europe. Responses were received between February and July 2021. Results: About 144 respondents from 27 European countries completed the survey. NBUVB was the most widely used [n = 138 (96%)]. Home‐based NBUVB was available in 8/27 countries (25/144 respondents, 17%). Oral psoralen‐UVA (PUVA) was more widely available than bath PUVA (n = 106, 74% vs. n = 60, 42%) and used mainly in adult patients. 49/144 (34%) of respondents had access to UVA1. Phototherapy would be considered instead of systemic treatment in 96% of adults and 82% of children for NBUVB, versus 40% of adults and 3% of children for PUVA. Starting doses, standard dosing increments, length of treatment courses, lifetime limits for treatments and thresholds for performing annual skin assessments varied between responders. Conclusions: NBUVB was the most widely used phototherapy for AD in adult and paediatric patients, while PUVA and UVA1 were less used. Prescribing practices varied considerably, highlighting the lack of consensus practice in many different aspects of phototherapy for the treatment of AD in children and adults. This indicates that further studies are required to determine optimal phototherapeutic regimens for AD and informs our understanding of parameters that should be included in future high‐quality randomized controlled trials (RCT) of phototherapy. [ABSTRACT FROM AUTHOR]

Background Recent findings have established the 308-nm xenon chloride excimer laser (EL) as a new option in the area of ultraviolet (UV) B phototherapy. As this laser enables high radiant exposure of narrowband UVB and precise targeting of affected skin, it appears to be a promising treatment for the prurigo form of atopic dermatitis (AD). Objectives To investigate the efficacy and safety of the EL compared with clobetasol propionate (CP) in the prurigo form of AD. Methods In a prospective randomized within-patient controlled study, 13 patients with a prurigo form of AD were randomized to receive EL on one side and topical CP on the other side. Laser treatment was performed twice a week for 10 weeks. Clinical responses were evaluated using Physician Assessment of Individual Signs, Physician Global Assessment, Patient Global Assessment and photographic documentation. Histopathological changes were evaluated and duration of remission was monitored during a 6-month follow-up period. Results Both treatments resulted in a significant improvement of all outcome measures after 10 weeks of treatment. During follow up, the EL showed more improvement compared with CP. Histopathology demonstrated marked decrease of epidermal thickness and inflammatory infiltrate at the EL-treated sites. No significant side-effects occurred. Conclusions This study suggests that the EL can safely and effectively be used in the treatment of the prurigo form of AD. For the long term, the EL might be a good alternative to topical corticosteroids and an option in case of therapy-resistant patients. [ABSTRACT FROM AUTHOR]

Background : In this retrospective analysis the effect of narrowband ultraviolet B treatment in combination with acitretin is reviewed in 40 patients with plaque psoriasis. Narrowband UVB is highly effective for plaque psoriasis, but requires multiple phototherapy treatments, making patient compliance problematic. Oral acitretin is moderately effective as monotherapy, but when combined with ultraviolet B or PUVA, its use has reduced the number of treatments required for clearing, and has resulted in clearing of patients otherwise refractory to these phototherapeutic modalities. There is only sparse data on the combination of acitretin with narrowband UVB. We therefore analyzed data on 40 patients treated with this combination. results : The majority of patients treated had psoriasis that was refractory to treatment with broadband ultraviolet B, monotherapy with narrowband UVB, monotherapy with acitretin, or the combination of acitretin and broadband UVB. In this difficult-to-treat group of patients, the combination of low dose acitretin (25 mg po daily) and narrowband UVB three times per week resulted in greater than 75% improvement in 29 (72.5%) patients. Only 5 (12.5%) patients had less than 50% improvement. The combination was well tolerated and associated with typical retinoid and narrowband UVB side effects including elevation of serum lipids, burn and cheilitis. conclusion : The combination of acitretin with narrowband UVB results in faster improvement even in more difficult-to-treat patients. In combination the treatments appear to have synergistic effects. [ABSTRACT FROM AUTHOR]

In this retrospective analysis, the effect of currently used treatments in 26 patients with psoriasis of the palms and soles were analyzed. In general, patients are treated initially with topical medications including superpotent topical corticosteroids in combination with calcipotriene ointment or tazarotene gel or both. If satisfactory improvement is not achieved in 4-8 weeks, systemic retinoids are added, formerly etretinate and currently acitretin, except in women of childbearing potential. If the latter regimen is not effective within two months, soak PUVA is added to the regimen of oral retinoids and topical medications. If improvement is inadequate, or if the treatment regimen is not tolerated, methotrexate or cyclosporine have been added in the past. The availability of the excimer laser has recently modified our approach so that this therapy is used in combination with acitretin before soak PUVA. With the availability of biologic agents, methotrexate is avoided because of its hepatotoxicity and bone marrow toxicity and cyclosporine is avoided because of its nephrotoxicity. If oral acitretin plus topical therapy is not adequate to control the disease and the excimer laser is not an option because of its limited availability, alefacept, etanercept and infliximab are added when possible. Other biologic agents are likely to be added to this list in the future. [ABSTRACT FROM AUTHOR]

BACKGROUND: In this retrospective analysis the effect of narrowband ultraviolet B treatment in combination with acitretin is reviewed in 40 patients with plaque psoriasis. Narrowband UVB is highly effective for plaque psoriasis, but requires multiple phototherapy treatments, making patient compliance problematic. Oral acitretin is moderately effective as monotherapy, but when combined with ultraviolet B or PUVA, its use has reduced the number of treatments required for clearing, and has resulted in clearing of patients otherwise refractory to these phototherapeutic modalities. There is only sparse data on the combination of acitretin with narrowband UVB. We therefore analyzed data on 40 patients treated with this combination. RESULTS: The majority of patients treated had psoriasis that was refractory to treatment with broadband ultraviolet B, monotherapy with narrowband UVB, monotherapy with acitretin, or the combination of acitretin and broadband UVB. In this difficult-to-treat group of patients, the combination of low dose acitretin (25 mg po daily) and narrowband UVB three times per week resulted in greater than 75% improvement in 29 (72.5%) patients. Only 5 (12.5%) patients had less than 50% improvement. The combination was well tolerated and associated with typical retinoid and narrowband UVB side effects including elevation of serum lipids, burn and cheilitis. CONCLUSION: The combination of acitretin with narrowband UVB results in faster improvement even in more difficult-to-treat patients. In combination the treatments appear to have synergistic effects. [ABSTRACT FROM AUTHOR]

Background The identification of a highly potent immunosuppressive/antiproliferative agent with an acceptable toxicity profile has long been a goal for the management of severe plaque psoriasis. Objectives To investigate the efficacy and safety of sirolimus (Rapamune®) for severe psoriasis when given alone or in association with cyclosporin. Methods In a randomized, double-blind, eight parallel group, pilot study in 24 out-patient centres in seven European countries, 150 patients, 18 years and older, with severe chronic plaque psoriasis were given sirolimus 0·5, 1·5 and 3·0 mg m-2 daily for 8 weeks, either alone or in association with a subtherapeutic dose of cyclosporin (1·25 mg kg-1 daily). Cyclosporin 5 mg kg-1 daily was the positive control and cyclosporin 1·25 mg kg-1 daily the negative control. The primary efficacy variable was the mean percentage reduction in Psoriasis Area and Severity Index (PASI). Safety assessments included monitoring of adverse events, clinical laboratory parameters and sirolimus/cyclosporin blood concentrations. Results The greatest mean percentage decreases in PASI were seen with cyclosporin 5·0 mg kg-1 daily (70·5%) and with sirolimus 3·0 mg m-2 daily + cyclosporin 1·25 mg kg-1 daily (63·7%). Both groups demonstrated significantly better results than cyclosporin 1·25 mg kg-1 daily (mean decrease 33·4%). Serum creatinine levels were significantly lower for groups with sirolimus alone and sirolimus plus reduced-dose cyclosporin when compared with cyclosporin 5·0 mg kg-1 daily. Adverse events associated with sirolimus included thrombocytopenia (5%), hyperlipidaemia (9%), aphthous stomatitis (9%) and acne (13%), whereas adverse events associated with cyclosporin included hot flushes (12%), hyperlipidaemia (9%) and increased serum creatinine (9%). Conclusions... [ABSTRACT FROM AUTHOR]

The article reports on the change in healthcare management towards patient centredness in Great Britain. According to the authors, in most of the dermatological diseases, one does not know which results can be considered most significant to patients and their medical care providers. They say that policymakers may be interested in safety and costs therapies.

Background: Evidence on the (long‐term) safety of systemic immunomodulating therapies in atopic dermatitis (AD) generated by real‐world data is sparse. Objectives: To describe real‐world reported adverse drug reactions (AEs) related to systemic immunomodulating therapy in patients with AD and to compare the incidence rates of AEs with the Summaries of Product Characteristics (SmPCs). Methods: We conducted an observational prospective multi‐centre cohort study, using the TREAT NL registry. All severe AEs, AEs of special interest and serious AEs in adult and paediatric patients on systemic immunomodulating treatment (ciclosporin, methotrexate, azathioprine, mycophenolic acid, dupilumab, tralokinumab, baricitinib and upadacitinib) were assessed. Incidences rates of all (potentially) drug‐related AEs were standardized in patient years and compared to the cumulative incidences in the associated SmPCs. Results: We collected 422 patient years of safety data from 266 patients, of whom 129 (48.5%) reported a total of 224 (potentially) drug‐related AEs. Compared to dupilumab's SmPC, higher incidence rates were found for four AEs (reported ≥5 times): eosinophilia, blepharitis, dry eyes and head and neck erythema (i.e. dupilumab facial redness). A higher incidence rate of fatigue was found in patients on oral methotrexate in our cohort compared to the SmPC. Two new drug‐related AEs (reported ≥5 times) were found in patients on dupilumab, including non‐infectious conjunctivitis and meibomian gland dysfunction. Conclusions: Real‐world reported AEs captured in AD patient registries can add information on the estimated incidence of AEs and benefit clinical decision aids. Future studies using data derived from the TREAT NL registry combined with data from other registries within the TREAT Registry Taskforce will provide more information on (rare) AEs associated with immunomodulating therapy in AD patients. [ABSTRACT FROM AUTHOR]

With biologic drugs dominating the therapeutic space for severe immune‐mediated inflammatory disease, it is critical for clinicians to be familiar with the concept of drug immunogenicity, with the potential for our patients to develop antidrug antibodies (ADA) of clinical relevance. Whilst there are clear differences between different therapeutic biologics in terms of reported ADA rates, there is no accepted dermatology guideline or grouping of drugs by risk of clinically relevant ADA, nor a consensus on approach to ADA management. This is partly because making valid comparisons of immunogenicity across drugs is fundamentally flawed: the differing types of ADA assay, trial design and included patient population – as well as the molecular structure of the biologic molecules themselves – are all highly influential on reported ADA prevalence and impact on clinical response. Therefore, the first part of this article aims to give an overview of ADA that also clarifies common misconceptions on the subject, whilst the second part of this article outlines Phase III immunogenicity data on commonly used biologics for psoriasis, the most common dermatological indication. Based on this, and acknowledging current limitations in available evidence, we propose a working categorization of biologics together with a broad approach to management: Group 1 – biologics with higher risk of clinically relevant ADA; Group 2 – biologics with lower risk of clinically relevant ADA; and Group 3 – biologics with no established risk of clinically relevant ADA. However, these groupings represent a working concept only; more research is required, using comparable ADA assays and consistent reporting of related outcomes. Finally, there is an urgent need for better characterization of individuals at particular risk of developing ADA to inform future clinical decision‐making. [ABSTRACT FROM AUTHOR]

This article explores the genetic and clinical aspects of autosomal recessive congenital ichthyosis (ARCI) caused by mutations in the NIPAL4 and PNPLA1 genes. The study investigates potential treatments for ARCI, including anti-interleukin therapy for cytokine dysregulation and pruritus. The authors conducted a retrospective analysis of patients with these gene mutations and evaluated their response to specific treatments. The results showed varying effects, highlighting the need for further research in this area. The article also includes a table summarizing the genetic variants and clinical features of twelve patients with different forms of ichthyosis and palmoplantar keratoderma. The study was conducted as part of the European Reference Network-SKIN subthematic group Ichthyosis and Palmoplantar Keratoderma and received ethical approval. [Extracted from the article]

The Harmonising Outcome Measures for Eczema (HOME) initiative established a core outcome set (COS) for atopic eczema (AE) clinical trials in 2019. This set encompasses four core outcome domains and corresponding measurement instruments: clinical signs (EASI), patient-reported symptoms (POEM and NRS 11 point for worst itch over the last 24 h), quality of life (DLQI/CDLQI/IDQoLI), and long-term control (Recap or ADCT). Following its roadmap, the HOME initiative is now focused on supporting implementation of the COS. To identify barriers and facilitators to implementation of the COS, and to guide the effort to promote COS uptake, a virtual consensus meeting was held over 2 days (September 25–26, 2021) attended by 55 participants (26 healthcare professionals, 16 methodologists, 5 patients, 4 industry representatives, and 4 students). Implementation themes were identified by a pre-meeting survey distributed to HOME members, presentations, and whole-group discussion. Participants were divided into five multi-professional small groups which ranked their top 3 most important themes, followed by whole-group discussion and anonymous consensus voting (consensus criteria: < 30% disagreement). Three most important implementation themes were identified and agreed upon: (1) awareness and stakeholder engagement, (2) universal applicability of the COS, and (3) ensuring minimum administrative burden. Working groups to address these issues are now a priority for the HOME initiative. The results from this meeting will inform the development of a HOME Implementation Roadmap in an effort to support other COS groups planning for effective implementation of their core sets. [ABSTRACT FROM AUTHOR]

Summary: Background: Alexithymia refers to difficulty in identifying and expressing emotions. Alexithymia is associated with high burden of disease in patients with psoriasis. Objectives: To investigate whether alexithymia was reversible in patients with psoriasis following real‐life therapeutic intervention. Methods: The Epidemiological Study in Patients with Recently Diagnosed Psoriasis (EPIDEPSO; NCT01964443) was a 1‐year multicentre observational study investigating the prevalence of alexithymia and other psychosocial comorbidities in patients with psoriasis with ≤ 10 years' disease duration and eligible for systemic treatment. Alexithymia was assessed using the Toronto Alexithymia Scale (TAS‐20) at baseline, 6 months and 1 year. Results: There was a statistically significant decrease in the prevalence of alexithymia in the follow‐up cohort, from 26·7% at baseline to 21·2% at 6 months and 18·8% at 1 year. More than half of the patients (n = 77, 53·8%) who were alexithymic at baseline experienced reversion of their alexithymia. Reversion of alexithymia was higher in patients who reached a high level of disease control, defined as ≥ 75% or ≥ 90% improvement in Psoriasis Area and Severity Index. Reversion of alexithymia was associated with dramatic improvement in quality of life, anxiety and depression. Moreover, hazardous alcohol use, highly prevalent in patients with alexithymia, was reduced almost threefold at 1 year. Conclusions: Alexithymia and associated high disease burden may be reversible in patients with effective treatment of psoriasis. Proactive recognition of patients who are unable to identify and express their feelings is important. What's already known about this topic? Alexithymia, the inability to identify and express emotions, is highly prevalent in patients with psoriasis.Patients with alexithymia have a high disease burden, with impaired quality of life, anxiety and depression. What does this study add? Alexithymia may be reversible in patients with psoriasis.Higher psoriasis clearance is associated with a lower prevalence of alexithymia at 1 year.Anxiety, depression and harmful alcohol use are reduced in patients who have a reversion in alexithymia. Linked Comment: Misery. Br J Dermatol 2019; 180:261. Plain language summary available online Respond to this article [ABSTRACT FROM AUTHOR]

In this article the author comments on a research conducted by Swedish Hospital Discharge Registry and the Swedish Cancer Registry analyzing the survival rates of cancer patients admitted for the treatment of psoriasis, published within the issue. It is mentioned that the study was population based and studies a large number of population. However, in conducting studies no sample size was defined and was limited to the patients suffering from psoriasis only.

A letter to the editor is presented in response to the article about multiple randomized controlled trials, which appeared in the previous issue.

Background Single-centre studies show that alexithymia, defined as difficulty in recognizing and describing emotions, is more prevalent among patients with psoriasis than in the general population. However, its prevalence and the consequences of the association between alexithymia and psoriasis are unclear. Objectives The primary objective of this study was to determine the prevalence of alexithymia, as defined by a score ≥ 61 in the 20-item Toronto Alexithymia Scale, in a large sample of patients who had plaque psoriasis for ≤ 10 years and were eligible for phototherapy or systemic treatment. The secondary objectives were to investigate the relationship between alexithymia and the clinical and psychological aspects of psoriasis. Methods Data were collected in the framework of an observational, multicentre, international study, the EPidemiological Study In Patients With Recently DiagnosEd PSOriasis ( EPIDEPSO), aiming at investigating the prevalence of alexithymia and other psychosocial comorbidities in patients with psoriasis of ≤ 10 years' disease duration. Results The prevalence of alexithymia within a cohort of 670 patients was 24·8% (95% confidence interval 21·7-28·2). Patients with alexithymia had a higher burden of psoriasis, including significant impairment of quality of life, higher levels of anxiety and depression, a higher risk of alcohol dependency and impairment of work productivity, compared with patients without alexithymia. Conclusions It is important to identify alexithymic patients with psoriasis in clinical practice as they experience a higher disease burden and have a lower ability to express their feelings. [ABSTRACT FROM AUTHOR]

Background In 2003, the Dutch psoriasis guidelines were among the first evidence-based medicine guidelines in dermatology. Although pivotal, the implementation of dermatological guidelines has not been assessed. Objectives To evaluate various aspects that affect implementation of clinical guidelines such as knowledge, attitudes and practices among dermatologists. Methods A cross-sectional anonymous postal survey was conducted among all Dutch dermatologists. In addition to questions about knowledge and practices, 24 items assessed guidelines attitudes. Factor analysis was applied to merge these items into attitudinal scales and multiple linear regression was used to identify predictors for these scales. Results Of the 353 dermatologists, 161 (46%) completed the questionnaire. Almost all respondents were aware of the guidelines and 60% reported to have a decent knowledge of their content. Factor analysis retained 22 items divided into three scales: usefulness and content, barriers, and reliability. Apart from some disagreement on the user-friendliness and communication facilitating properties, the dermatologists’ attitudes were generally positive. A larger volume of patients with psoriasis was associated with more frequent use of the guidelines [adjusted odds ratio (OR) = 2·42; 95% confidence interval (CI) 1·02–5·72]. Good familiarity predicted a more positive attitude towards the guidelines’ usefulness and content ( P < 0·001), perceived barriers ( P < 0·001), and more frequent use in practice (adjusted OR = 8·38; 95% CI 3·08–22·81). Conclusions Dutch dermatologists seem to know and appreciate their psoriasis guidelines and use them more often when they have a larger psoriasis population. Enhancing the familiarity of the guidelines among users may result in a more positive attitude towards them and a higher frequency of use. [ABSTRACT FROM AUTHOR]

Background Etanercept and efalizumab recently became available and reimbursed for routine use in severe psoriasis in the Netherlands. The criteria for reimbursement are Psoriasis Area and Severity Index (PASI) ≥ 10 (or Skindex-29 ≥ 35 if PASI ≥ 8 and < 10) and ineffectiveness of ultraviolet (UV) B/psoralen plus UVA, methotrexate and ciclosporin, or a contraindication to or serious side-effect(s) during these treatments. Objectives We hypothesized: (i) that efficacy would be lower than that obtained in published phase II and III studies because (a) resistance to all conventional therapies as a reimbursement condition would select for more resistant cases and (b) inclusion would be more restricted to severe cases (higher PASI), and (ii) that efficacy would be lower in obese patients due to the possible role of adipose tissue in tumour necrosis factor (TNF)- α homeostasis. Methods We treated 50 patients (38 men, 12 women; mean PASI 15·8) with etanercept 25 mg or 50 mg twice weekly and evaluated in a retrospective analysis the efficacy and safety in comparison with data from published trials. Additionally, we related the clinical effect to the body mass index (BMI), for adipose tissue is thought to have a possible role in TNF- α homeostasis. Results Based on the literature, 30% and 49% of the patients treated with etanercept 25 mg and 50 mg twice weekly, respectively, should have achieved 75% or more improvement in PASI compared with baseline (PASI 75), and 10% and 21%, respectively, should have achieved 90% or more improvement (PASI 90). Our data showed that 21% in the 2 × 25 mg group and 23% in the 2 × 50 mg group achieved PASI 75. PASI 90 was only attained in 7% of patients treated with 2 × 25 mg and 6% of those treated with 2 × 50 mg. Contrary to our hypothesis, the mean initial PASI was comparable with the mean PASI mentioned in the phase II and III clinical trials. Although fatigue is not identified as a side-effect of etanercept, 10% of our patients reported fatigue as an adverse event during etanercept treatment. High BMI, indicating overweight or obesity, was found both in patients with little efficacy and in patients achieving PASI 75 or better. Conclusions Use of etanercept in real practice gives impressive results, but these are generally less favourable than those published in clinical trial reports. This is probably due to the stringent conditions for reimbursement, which select for more treatment-resistant patients. Fatigue as a possible side-effect of etanercept should also be an issue for further investigation. Finally, the BMI does not seem to influence the patients’ response to etanercept, although further investigations would be needed to confirm this. [ABSTRACT FROM AUTHOR]

Dupilumab is a relatively new treatment option for patients with moderate to severe atopic dermatitis. There is a lack of knowledge about the effects of treatment with dupilumab during conception for both men and women, as well as during pregnancy and lactation in women. We report four patients (two men, two women) who expressed a wish to conceive during treatment with dupilumab in daily practice. Both men conceived during dupilumab treatment, while the two women discontinued dupilumab because of anticipated pregnancy. Apart from disease flares in both of the patients who discontinued treatment, no complications were reported concerning the ability to conceive, the course of the pregnancy or the fetal outcome. We present an overview of the current available literature on dupilumab during conception, pregnancy and lactation, which can guide considerations for patients on dupilumab wishing to conceive a child. Until more data are available, preference should be given to treatment with topical corticosteroids, phototherapy, systemic corticosteroids and ciclosporin. [ABSTRACT FROM AUTHOR]

BACKGROUND: In this retrospective analysis the effect of narrowband ultraviolet B treatment in combination with acitretin is reviewed in 40 patients with plaque psoriasis. Narrowband UVB is highly effective for plaque psoriasis, but requires multiple phototherapy treatments, making patient compliance problematic. Oral acitretin is moderately effective as mono-therapy, but when combined with ultraviolet B or PUVA, its use has reduced the number of treatments required for clearing, and has resulted in clearing of patients otherwise refractory to these phototherapeutic modalities. There is only sparse data on the combination of acitretin with narrowband UVB. We therefore analyzed data on 40 patients treated with this combination, RESULTS: The majority of patients treated had psoriasis that was refractory to treatment withbroadband ultraviolet B, mono-therapy with narrowband UVB, monotherapy with acitretin, or the combination of acitretin and broadband UVB. In this difficult-to-treat group of patients, the combination of low dose acitretin (25 mg po daily) and narrowband UVB three times per week resulted in greater than 75% improvement in 29 (72.5%) patients. Only 5 (12.5%) patients had less than 50% improvement. The combination was well tolerated and associated with typical retinoid and narrowband UVB side effects including elevation of serum lipids, burn and cheilitis. CONCLUSION: The combination of acitretin with narrowband DVB results in faster improvement even in more difficult-to-treat patients. In combination the treatments appear to have synergistic effects. [ABSTRACT FROM AUTHOR]

Background: Standardized outcome reporting is crucial for trial evidence synthesis and translation of findings into clinical decision‐making. The OMERACT 2.0 Filter and COMET outcome domain taxonomy propose frameworks for consistent reporting of outcomes. There is an absence of a uniform dermatology‐specific reporting strategy that uses precise and consistent outcome definitions. Objectives: Our aim was to map efficacy/effectiveness outcomes assessed in dermatological trials to the OMERACT 2.0 Filter as a starting point for developing an outcome taxonomy in dermatology. Methods: We critically appraised 10 Cochrane Skin Reviews randomly selected from all 69 Cochrane Skin Reviews published until 01/2015 and the 220 trials included covering a broad spectrum of dermatological conditions and interventions. Efficacy/effectiveness outcomes were mapped to core areas and domains according to the OMERACT 2.0 Filter. The extracted trial outcomes were used for critical appraisal of outcome reporting in dermatology trials and for the preliminary development of a dermatology‐specific outcome taxonomy. Results: The allocation of 1086 extracted efficacy/effectiveness outcomes to the OMERACT 2.0 Filter resulted in a hierarchically structured dermatology‐specific outcome classification. In 506 outcomes (47%), the outcome concept to be measured was insufficiently described, hindering meaningful evidence synthesis. Although the core areas assessed in different dermatology trials of the same condition overlap considerably, quantitative evidence synthesis usually failed due to imprecise outcome definitions, non‐comparable outcome measurement instruments, metrics and reporting. Conclusions: We present an efficacy/effectiveness outcome classification as a starting point for a dermatology‐specific taxonomy to provide trialists and reviewers with the opportunity to better synthesize and compare evidence. Linked Commentary: A. Ragamin et al. J Eur Acad Dermatol Venereol 2021; 35: 276‐277. https://doi.org/10.1111/jdv.17103. [ABSTRACT FROM AUTHOR]

Summary: Background: Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers) but no validated instruments for the domain have been identified. Objectives: To develop a measurement instrument to capture a patient's perspective of eczema control that is suitable for use in eczema clinical trials. Methods: Best practice for the development of a patient‐reported outcome was followed. A mixed‐methods approach was used to develop and refine a conceptual framework, generate, refine and select items and to test the distribution and construct validity of the final scale. The mixed‐methods approach involved expert panel meetings (including patient representatives, healthcare professionals and methodologists), and data collection using a focus group, cognitive interviews and an online survey with people with eczema and caregivers. Multivariable linear regression was used in the item selection process. Results: Fourteen expert panel members co‐produced the instrument, with input from people with eczema and caregivers via a focus group (n = 6), cognitive interviews (n = 13) and an online survey (n = 330). The resulting instrument, Recap of atopic eczema (RECAP), is a seven‐item questionnaire that captures eczema control via self or caregiver report. The development process aimed to ensure good content validity and feasibility. Initial testing suggested no floor or ceiling effects and good construct validity. Hypothesized correlation with the Patient‐Oriented Eczema Measure was confirmed [r(258) = 0·83, P < 0·001]. Conclusions: RECAP has the potential to improve reporting of eczema control in research and clinical practice. Further exploration of measurement properties is required. Linked Comment: Pattinson and Bundy. Br J Dermatol 2020; 183:418–419. What's already known about this topic? Eczema control has been identified as an important outcome by key stakeholders in eczema research (including patients, carers, healthcare professionals and researchers).Qualitative studies suggest eczema control is a multifaceted and individual experience and no instrument has been identified that captures eczema control in this way. What does this study add? We have developed Recap of atopic eczema (RECAP), a seven‐item questionnaire to capture the experience of eczema control in all ages and eczema severities; there are two versions: a self‐reported version for adults and older children with eczema, and a caregiver‐reported version for younger children with eczema.Designed with input from people with eczema, caregivers and healthcare professionals to ensure good content validity.Initial testing of score distributions and construct validity suggests good measurement properties. What are the clinical implications of the work? The RECAP instrument is appropriate and feasible for measuring eczema control in clinical trials and may also be useful in routine practice. Linked Comment: Pattinson and Bundy. Br J Dermatol 2020; 183:418–419. Plain language summary available online [ABSTRACT FROM AUTHOR]

A letter to the editor is presented that discusses the evaluation of the reimbursement criteria for biological therapies in the Netherlands.

Summary: Patients with atopic dermatitis (AD) have an increased risk of bacterial skin infections, which cause significant morbidity and, if untreated, may become systemic. Staphylococcus aureus colonizes the skin of most patients with AD and is the most common organism to cause infections. Overt bacterial infection is easily recognized by the appearance of weeping lesions, honey‐coloured crusts and pustules. However, the wide variability in clinical presentation of bacterial infection in AD and the inherent features of AD – cutaneous erythema and warmth, oozing associated with oedema, and regional lymphadenopathy – overlap with those of infection, making clinical diagnosis challenging. Furthermore, some features may be masked because of anatomical site‐ and skin‐type‐specific features, and the high frequency of S. aureus colonization in AD makes positive skin swab culture of suspected infection unreliable as a diagnostic tool. The host mechanisms and microbial virulence factors that underlie S. aureus colonization and infection in AD are incompletely understood. The aim of this article is to present the latest evidence from animal and human studies, including recent microbiome research, to define the clinical features of bacterial infections in AD, and to summarize our current understanding of the host and bacterial factors that influence microbial colonization and virulence. [ABSTRACT FROM AUTHOR]

Atopic dermatitis (AD) is a common inflammatory skin disease that affects both children and adults, including a large number of adults of reproductive age. Several guidelines for the treatment of AD exist, yet specific recommendations for the treatment of pregnant or lactating women and for adults planning to have a child are often lacking. This position paper from the European Task force on Atopic Dermatitis (ETFAD) is based on up‐to‐date scientific literature on treating pregnant and lactating women as wells as adults with AD planning to have a child. It is based on the expert opinions of members of the ETFAD and on existing safety data on the proposed treatments, many of which are derived from patients with other inflammatory diseases or from transplantation medicine. For treating future parents, as well as pregnant and lactating women with AD, the use of topical treatments including moisturizers, topical corticosteroids, tacrolimus, antiseptics such as chlorhexidine, octenidine, potassium permanganate and sodium hypochlorite (bleach) is deemed to be safe. Ultraviolet (UV) therapy may also be used. Systemic treatment should be prescribed only after careful consideration. According to the opinion of the ETFAD, treatment should be restricted to systemic corticosteroids and cyclosporine A, and, in selected cases, azathioprine. [ABSTRACT FROM AUTHOR]

Linked Article: Sampogna et al. Br J Dermatol 2019; 180:397–403 [ABSTRACT FROM AUTHOR]

Summary: Alexithymia means the inability to identify and express emotions. This condition is more common in people with chronic inflammatory diseases such as arthritis and inflammatory bowel disease. This international team previously showed, in the 'Epidemiological Study In Patients With Recently DiagnosEd PSOriasis' (EPIDEPSO), that alexithymia also affects adults with severe psoriasis; those affected are more likely to suffer from anxiety and depression and have a high risk of alcohol dependency and unemployment. An important question is whether alexithymia is a fixed personality trait, or a state which can improve if the psoriasis gets better: perhaps some psoriasis patients block their recognition of emotion as a defence against feeling stigmatised. To answer this, the authors followed up 467 of the original EPIDEPSO patients a year after starting systemic medication (i.e. it works on the whole body, rather than just being applied to the skin) or ultra‐violet light treatment. The prevalence of alexithymia reduced significantly from 26.7% to 18.8% and this improvement was most evident in patients younger than 40 years, who had suffered anxiety and depression, with psoriasis of recent onset, on visible areas, or that responded well to treatment. Patients who were clear or almost clear of psoriasis at follow‐up showed the greatest improvement in alexithymia. Hazardous alcohol use reduced by almost 3‐fold after 1 year. Although improvement in alexithymia was related to improvement in psoriasis, the authors acknowledge that the assessment tools they used are not perfect and that they have not established cause and effect. Nonetheless, they conclude that patients with alexithymia and severe psoriasis require psychological counselling as well as active psoriasis treatment. Linked Article: Sampogna et al. Br J Dermatol 2019; 180:397–403 [ABSTRACT FROM AUTHOR]

Summary: Background: Systemic treatment is indicated for moderate‐to‐severe atopic dermatitis (AD) refractory to topical treatment. Long‐term evidence, up to 5 years, of off‐label prescribed methotrexate (MTX) and azathioprine (AZA) is lacking. Objectives: To investigate long‐term effectiveness, safety and drug survival of MTX and AZA. Methods: In an open‐label follow‐up phase of a clinical trial, patients were seen every 3 months for 5 years. MTX and AZA doses could be increased or decreased concurrent with daily clinical practice. Primary effectiveness outcomes were mean absolute and relative reduction in SCORing Atopic Dermatitis (SCORAD) index and Investigator's Global Assessment (IGA) after 5 years compared with baseline. To assess safety, the type, frequency, severity and relatedness to treatment of adverse events were investigated. Drug survival was analysed by Kaplan–Meier curves. Results: Thirty‐five of 43 originally included patients participated, of whom 27 completed the follow‐up. At year 5, the mean relative reduction in SCORAD index was similar in the MTX and AZA groups: 53% and 54% using descriptive analysis. Twelve serious adverse events occurred in 5 years; for three there was a possible causal relationship. Drug survival demonstrated a longer survival for MTX, but survival in both groups was low after 5 years (MTXn = 5, AZAn = 1). Conclusions: Based on this relatively small pragmatic study, MTX and AZA seem to be effective and safe as maintenance treatments in moderate‐to‐severe AD up to 5 years. Few patients in both groups survive on their originally allocated drug although some discontinued because of controlled AD. [ABSTRACT FROM AUTHOR]

Summary: This is the report from the fifth meeting of the Harmonising Outcome Measures for Eczema initiative (HOME V). The meeting was held on 12–14 June 2017 in Nantes, France, with 81 participants. The main aims of the meeting were (i) to achieve consensus over the definition of the core domain of long‐term control and how to measure it and (ii) to prioritize future areas of research for the measurement of the core domain of quality of life (QoL) in children. Moderated whole‐group and small‐group consensus discussions were informed by presentations of qualitative studies, systematic reviews and validation studies. Small‐group allocations were performed a priori to ensure that each group included different stakeholders from a variety of geographical regions. Anonymous whole‐group voting was carried out using handheld electronic voting pads according to predefined consensus rules. It was agreed by consensus that the long‐term control domain should include signs, symptoms, quality of life and a patient global instrument. The group agreed that itch intensity should be measured when assessing long‐term control of eczema in addition to the frequency of itch captured by the symptoms domain. There was no recommendation of an instrument for the core outcome domain of quality of life in children, but existing instruments were assessed for face validity and feasibility, and future work that will facilitate the recommendation of an instrument was agreed upon. [ABSTRACT FROM AUTHOR]

Summary: Results of clinical trials are the most important information source for generating external clinical evidence. The use of different outcomes across trials, which investigate similar interventions for similar patient groups, significantly limits the interpretation, comparability and clinical application of trial results. Core outcome sets (COSs) aim to overcome this limitation. A COS is an agreed standardized collection of outcomes that should be measured and reported in all clinical trials for a specific clinical condition. The Core Outcome Set Initiative within the Cochrane Skin Group (CSG‐COUSIN) supports the development of core outcomes in dermatology. In the second CSG‐COUSIN meeting held in 2017, 11 COS development groups working on skin diseases presented their current work. The presentations and discussions identified the following overarching methodological challenges for COS development in dermatology: it is not always easy to define the disease focus of a COS; the optimal method for outcome domain identification and level of detail needed to specify such domains is challenging to many; decision rules within Delphi surveys need to be improved; appropriate ways of patient involvement are not always clear. In addition, there appear to be outcome domains that may be relevant as potential core outcome domains for the majority of skin diseases. The close collaboration between methodologists in the Core Outcome Set Initiative and the international Cochrane Skin Group has major advantages for trialists, systematic reviewers and COS developers. [ABSTRACT FROM AUTHOR]

Summary: Background: Guidelines discourage the use of systemic corticosteroids for atopic dermatitis (AD), but their use remains widespread. Objectives: To reach consensus among an international group of AD experts on the use of systemic corticosteroids for AD. Methods: A survey consisting of statements accompanied by visual analogue scales ranging from ‘strongly disagree’ to ‘neutral’ to ‘strongly agree’ was distributed to the International Eczema Council (IEC). Consensus was reached in agreement on a statement if < 30% of respondents marked to the left of ‘neutral’ towards ‘strongly disagree’. Results: Sixty of 77 (78%) IEC members participated. Consensus was reached on 12 statements, including that systemic corticosteroids should generally be avoided but can be used rarely for severe AD under certain circumstances, including a lack of other treatment options, as a bridge to other systemic therapies or phototherapy, during acute flares in need of immediate relief, in anticipation of a major life event or in the most severe cases. If used, treatment should be limited to the short term. Most respondents agreed that systemic corticosteroids should never be used in children, but consensus was not reached on that statement. The conclusions of our expert group are limited by a dearth of high‐quality published evidence. If more stringent consensus criteria were applied (e.g. requiring < 20% of respondents marking towards ‘strongly disagree’), consensus would have been reached on fewer statements. Conclusions: Based on expert opinion from the IEC, routine use of systemic corticosteroids for AD is generally discouraged and should be reserved for special circumstances. [ABSTRACT FROM AUTHOR]

Summary: Background: Harmonization of outcome measures is needed to increase the value of clinical trials on nail psoriasis. Objectives: To provide the first step in core outcome set (COS) development for nail psoriasis. Methods: A systematic review was performed to identify outcome instruments and corresponding outcome domains used in (ongoing) randomized controlled trials. Results: Identified outcome domains included clinical signs, quality of life, symptoms and delivery of care. The Nail Psoriasis Severity Index (NAPSI) was the most commonly used measure to assess clinical signs (74% of studies). Other outcome instruments used included the Nail Area Severity score, composite fingernail score, a Physician's Global Assessment, individual nail features or a combination of these. Heterogeneity in type and reporting (e.g. NAPSI 50, NAPSI 75) of outcome instruments was high and characteristics were often insufficiently reported. In total 43% of studies assessed quality of life, with 3% of studies using a nail psoriasis‐specific tool. Assessment of symptoms and delivery of care was limited. Conclusions: Heterogeneity in the type and reporting of nail psoriasis outcome instruments needs to be addressed in the process towards COS development. Sufficient reporting of instrument characteristics should be encouraged. As nail psoriasis is generally assessed secondarily to psoriasis of the skin or joints, collaboration between different research groups in COS development is needed. [ABSTRACT FROM AUTHOR]

Summary: Background: An important limitation in vascular malformation research is the heterogeneity in outcome measures used for the evaluation of treatment outcome. Objectives: To reach international consensus on a core outcome set (COS) for clinical research on peripheral vascular malformations: lymphatic (LM), venous (VM) and arteriovenous malformations (AVM). In this consensus study, we determined what domains should constitute the COS. Methods: Thirty‐six possibly relevant outcome domains were proposed to an international group of physicians, patients and the parents of patients. In a three‐round e‐Delphi process using online surveys, participants repeatedly rated the importance of these domains on a five‐point Likert scale. Participants could also propose other relevant domains. This process was performed for LM, VM and AVM separately. Consensus was predefined as 80% agreement on the importance of a domain among both the physician group and the patient/parent group. Outcomes were then re‐evaluated in an online consensus meeting. Results: 167 physicians and 134 patients and parents of patients with LM (n = 50), VM (n = 71) and AVM (n = 29) participated in the study. After three rounds and a consensus meeting, consensus was reached for all three types of vascular malformations on the core domains of radiological assessment, physician‐reported location‐specific signs, patient‐reported severity of symptoms, pain, quality of life, satisfaction and adverse events. Vascular malformation type‐specific signs and symptoms were included for LM, VM and AVM, separately. Conclusions: Our recommendation is that therapeutic‐efficacy studies on peripheral vascular malformations should measure at least these core outcome domains. [ABSTRACT FROM AUTHOR]

The article presents a report on the European guidelines for dermatologist and general practitioners for systemic treatment of psoriasis vulgaris, in cooperation with European Association for Dermatology and Venereology and International Psoriasis Council. It mentions recommendations concerning treatment of patients with psoriasis vulgaris using secukinumab and apremilast. It also states use of randomized controlled trials to evaluate the efficacy of the treatment options.

Background: The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases.Methods: This is an investigator-initiated, multicenter randomized controlled trial (RCT) designed to compare the combination treatment of adalimumab and methotrexate with adalimumab monotherapy in patients with psoriasis. The primary outcome is adalimumab drug survival at week 49. Other outcomes include improvement in disease severity and quality of life, tolerability, and safety. Moreover, anti-adalimumab antibodies and adalimumab serum concentrations will be measured and correlations between genotypes and clinical outcomes will be assessed. Patient recruitment started in March 2014. Up to now, 36 patients have been randomized. Many more patients have been (pre)screened. A total of 93 patients is desired to meet an adequate sample size. In our experience, the main limitation for recruitment is prior adalimumab therapy and intolerability or toxicity for methotrexate in the past.Discussion: OPTIMAP is the first RCT to examine combination therapy with adalimumab and methotrexate in a psoriasis population. With data derived from this study we expect to provide valuable clinical data on long-term treatment outcomes. These data will be supported by assessment of the impact of concomitant methotrexate on adalimumab pharmacokinetics. Furthermore, the influence of several single nucleotide polymorphisms on adalimumab response will be analyzed in order to support the development of a more personalized approach for this targeted therapy.Trial Registration: NTR4499 . Registered on 7 April 2014. [ABSTRACT FROM AUTHOR]

Background Symptoms have been identified as a core outcome domain for atopic eczema (AE) trials. Various instruments exist to measure symptoms in AE, but they vary in quality and there is a lack of standardization between clinical trials. Our objective was to systematically evaluate the quality of the evidence on the measurement properties of AE symptom instruments, thereby informing consensus discussions within the Harmonising Outcome Measures for Eczema (HOME) initiative regarding the most appropriate instruments for the core outcome domain symptoms. Methods Using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist and predefined criteria for good measurement properties on identified development and validation studies of AE symptom instruments, a best evidence synthesis was performed to draw an overall conclusion on quality of the instruments and to provide recommendations. Results Eighteen instruments were identified and evaluated. When the quality and results of the studies were considered, only five of these instruments had sufficient validation data to consider them for the core outcome set for the core outcome domain symptoms. These were the paediatric Itch Severity Scale (ISS), Patient-Oriented Eczema Measure (POEM), Patient-Oriented SCOring Atopic Dermatitis (PO-SCORAD), Self-Administered Eczema Area and Severity Index (SA-EASI) and adapted SA-EASI. Conclusions ISS (paediatric version), POEM, PO-SCORAD, SA-EASI and adapted SA-EASI are currently the most appropriate instruments and therefore have the potential to be recommended as core symptom instrument in future clinical trials. These findings will be utilized for the development of a core outcome set for AE. [ABSTRACT FROM AUTHOR]

This report provides a summary of the third meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in San Diego, CA, U.S.A., 6-7 April 2013 (HOME III). The meeting addressed the four domains that had previously been agreed should be measured in every eczema clinical trial: clinical signs, patient-reported symptoms, long-term control and quality of life. Formal presentations and nominal group techniques were used at this working meeting, attended by 56 voting participants (31 of whom were dermatologists). Significant progress was made on the domain of clinical signs. Without reference to any named scales, it was agreed that the intensity and extent of erythema, excoriation, oedema/papulation and lichenification should be included in the core outcome measure for the scale to have content validity. The group then discussed a systematic review of all scales measuring the clinical signs of eczema and their measurement properties, followed by a consensus vote on which scale to recommend for inclusion in the core outcome set. Research into the remaining three domains was presented, followed by discussions. The symptoms group and quality of life groups need to systematically identify all available tools and rate the quality of the tools. A definition of long-term control is needed before progress can be made towards recommending a core outcome measure. [ABSTRACT FROM AUTHOR]

Background There is a paucity of evidence for the use of systemic agents in children with atopic eczema refractory to conventional therapy, resulting in considerable variation in patient management. Objectives The European TREatment of severe Atopic eczema in children Taskforce ( TREAT) survey was established to collect data on current prescribing practice, to identify factors influencing the use of specific systemic agents, and to inform the design of a clinically relevant intervention study. Methods Consultant physician members of the paediatric dermatology societies and interest groups of eight European countries were invited to participate in a web-based survey. The multiple-response format questionnaire collated data on clinical practice in general, as well as detailed information on the use of systemic agents in refractory paediatric atopic eczema. Results In total, 343/765 members (44·8%) responded to the invitational emails; 89·2% were dermatologists and 71% initiate systemic immunosuppression for children with severe atopic eczema. The first-line drugs of choice were ciclosporin (43·0%), oral corticosteroids (30·7%) and azathioprine (21·7%). Ciclosporin was also the most commonly used second-line medication (33·6%), with methotrexate ranked as most popular third choice (26·2%). Around half of the respondents (53·7%) replied that they routinely test and treat reservoirs of cutaneous infection prior to starting systemic treatment. Across the eight countries, penicillins were the first-line antibiotic of choice (78·3%). Conclusions In the absence of a clear evidence base, the European TREAT survey confirms the wide variation in prescribing practice of systemic immunosuppression in refractory paediatric atopic eczema. The results will be used to inform the design of a randomized controlled trial relevant to patient management across Europe. [ABSTRACT FROM AUTHOR]

Patients with moderate to severe psoriasis are undertreated. To solve this persistent problem, the consensus programme was performed to define goals for treatment of plaque psoriasis with systemic therapy and to improve patient care. An expert consensus meeting and a collaborative Delphi procedure were carried out. Nineteen dermatologists from different European countries met for a face-to-face discussion and defined items through a four-round Delphi process. Severity of plaque psoriasis was graded into mild and moderate to severe disease. Mild disease was defined as body surface area (BSA) ≤10 and psoriasis area and severity index (PASI) ≤10 and dermatology life quality index (DLQI) ≤10 and moderate to severe psoriasis as (BSA > 10 or PASI > 10) and DLQI > 10. Special clinical situations may change mild psoriasis to moderate to severe including involvement of visible areas or severe nail involvement. For systemic therapy of plaque psoriasis two treatment phases were defined: (1) induction phase as the treatment period until week 16; however, depending on the type of drug and dose regimen used, this phase may be extended until week 24 and (2) maintenance phase for all drugs was defined as the treatment period after the induction phase. For the definition of treatment goals in plaque psoriasis, the change of PASI from baseline until the time of evaluation (ΔPASI) and the absolute DLQI were used. After induction and during maintenance therapy, treatment can be continued if reduction in PASI is ≥75%. The treatment regimen should be modified if improvement of PASI is <50%. In a situation where the therapeutic response improved ≥50% but <75%, as assessed by PASI, therapy should be modified if the DLQI is >5 but can be continued if the DLQI is ≤5. This programme defines the severity of plaque psoriasis for the first time using a formal consensus of 19 European experts. In addition, treatment goals for moderate to severe disease were established. Implementation of treatment goals in the daily management of psoriasis will improve patient care and mitigate the problem of undertreatment. It is planned to evaluate the implementation of these treatment goals in a subsequent programme involving patients and physicians. [ABSTRACT FROM AUTHOR]

The development of evidence based guidelines is a demanding and time consuming process. Therefore it is important to share the knowledge and discuss the structure of these guidelines in detail. To present a method report on the development process of the European evidence based guidelines on the systemic treatment of psoriasis vulgaris with the aim to offer guidance to other guidelines groups with lesser experience and to critically appraise the methodology of the guidelines development process. The guidelines are based on the previously evaluated literature from three European national evidence based guidelines and an additional systematic search and evaluation of new literature. Further steps included a structured consensus conference and a DELPHI procedure to develop the recommendations, as well as several internal and external reviews. All steps were coordinated by the Division of evidence based medicine in cooperation with a group of methodologists. A total of 114 studies were included, serving as base for the efficacy chapters of the intervention. The recommendations, based on the efficacy and the level of evidence of the included studies were discussed and finally consented by the guidelines group. After subsequent reviews the guidelines were presented to the European Dermatology Forum, European Academy of Dermatology and Venereology and Union Européenne des Médicins Spécialistes for approval and published in October 2009. The development of European evidence based guidelines requires a coordinated structure which can be achieved by the integration of an experienced group of methodologists. Nevertheless further improvements are imaginable and might be considered for an update or other European evidence based guidelines. [ABSTRACT FROM AUTHOR]

Background Knowledge on the sequential treatment of psoriasis with biologics with regard to efficacy and safety is sparse. This also applies to the efficacy and safety of adalimumab in patients previously treated with etanercept. The relationship between the reasons for discontinuation of etanercept and the response to adalimumab is not clear in psoriasis. Objectives To evaluate the efficacy and safety of adalimumab in patients with psoriasis with primary failure, secondary failure or intolerance to etanercept in daily practice. Methods Data were extracted from two prospective registries from all patients with psoriasis with failure on etanercept treatment, who switched to adalimumab therapy. Thirty patients fulfilled these criteria. All patients were naive to biologics when etanercept was initiated. Primary endpoints were the percentage of patients achieving a 50% or 75% improvement of the baseline Psoriasis Area and Severity Index (PASI) score (PASI 50 and PASI 75, respectively) at weeks 12, 24 and 48. Secondary endpoints were the percentage of patients achieving PASI 90, the mean percentage improvement in the PASI score from baseline and the adverse event rate. Results Compared with the baseline PASI score before the start of etanercept, the mean percentage improvement in PASI and the PASI 50/75/90 response rates to adalimumab until week 48 were comparable to those achieved with etanercept. In the patients failing on etanercept, PASI 75 was achieved by 27%, 36% and 54% at weeks 12, 24 and 48 of adalimumab treatment, respectively. The majority of patients showed a beneficial response to adalimumab, irrespective of the reason for discontinuation of etanercept. Previous treatment with etanercept did not increase the adverse event rate nor change the nature of the side-effects. Conclusions Adalimumab seems to be an effective and safe treatment option for patients with psoriasis who failed on etanercept treatment irrespective of the reason for discontinuation. [ABSTRACT FROM AUTHOR]

The article presents the October 2009 issue of the "Journal of the European Academy of Dermatology and Venereology," which offers information on the European S3-Guidelines for treating psoriasis vulgaris. It notes that the guidelines are intended for dermatologists and for medical specialists involved treating the disease. The guidelines are also meant to aid the activity of contributing to the fulfilment of a need or purpose to health insurance organizations and political decision-makers.

A letter to the editor is presented in response to the article about medical research on systemic therapies for patients with psoriasis that appeared in previous issue.

In this retrospective analysis, the effect of currently used treatments in 26 patients with psoriasis of the palms and soles were analyzed. In general, patients are treated initially with topical medications including super-potent topical corticosteroids in combination with calcipotriene ointment or tazarotene gel or both. If satisfactory improvement is not achieved in 4-8 weeks, systemic retinoids are added, formerly etretinate and currently acitretin, except in women of childbearing potential. If the latter regimen is not effective within two months, soak PUVA is added to the regimen of oral retinoids and topical medications. If improvement is inadequate, or if the treatment regimen is not tolerated, methotrexate or cyclosporine havebeen added in the past. The availability of the excimer laser has recently modified our approach so that this therapy is used in combination with acitretin before soak PUVA. With the availability of biologic agents, methotrexate is avoided because of its hepatotoxicity and bone marrow toxicity and cyclosporine is avoided because of its nephrotoxicity. If oral acitretin plus topical therapy is not adequate to control the disease and the excimer laser is not an option because of its limited availability, alefacept, etanercept and infliximab are added when possible. Other biologic agents arc likely to be added to this list in the future. [ABSTRACT FROM AUTHOR]

Summary: 特应性皮炎(AD)俗称湿疹,是一种可引发剧烈瘙痒和/或疼痛的慢性炎症性皮肤病,可能会影响患者及其家属的睡眠和健康相关的生活质量。该疾病影响了发达国家/地区10–20%左右的人口。AD是全球50大常见疾病之一。全身治疗意味着药物将在体内而非皮肤上发挥疗效,这种治疗方法适用于中度到重度AD患者,以及对其而言局部(敷用在皮肤上)治疗已满足不了治疗需求的患者。大部分全身治疗都缺乏长期证据,用于未标志用途的氨甲喋呤(MTX)和硫唑嘌呤(AZA)处方药(非AD注册药物)的长期证据尤为缺乏。本项在荷兰开展的研究旨在确认MTX和AZA从长期来看是否是一种安全有效的治疗方法。患者参与了一项随机对照试验(一项对用于实际患者的不同治疗方法进行比较的研究)随访研究,在5年研究期间,每3个月将访视患者一次。患者的主治医生可以在必要时增加或减少MTX和AZA的剂量。研究人员使用评分系统比较患者接受治疗5年后的症状与其刚开始接受治疗时的症状,以衡量治疗方法的有效程度。在此案例中,特应性皮炎评分(SCORAD)指数中分数的下降表明,症状和研究者总体评估(IGA)均有所改善。另外还对不良事件(不乐见的副作用)进行了研究。还对药物存活率(即患者持续接受治疗的时长)进行了分析。最初共有43名患者参与了随机对照试验,而后其中35名患者参与了本项随访研究,但只有27名患者完成了为期5年整的随访。在第5年里,SCORAD指数的平均相对下降率与MTX和AZA对照组的相仿。分别为52.8%和53.8%。5年内发生了12起严重不良事件;其中3起不良事件的产生原因可能源于治疗方法。MTX的药物存活率更长,但是5年后,两组的药物存活率都很低(MTX n = 5,AZA n = 1)。基于此项规模相对较小的研究,MTX和AZA对中度到重度AD患者而言,在5年内似乎是一项安全有效的维持性治疗方法。虽然还有少部分患者在继续服用最初分配给他们的药物,但是有些人因为症状已经消除而停止接受了治疗。这种低药物存活率强调了为AD患者采取有效治疗方法的必要性。此外,需要开展更为长期、更为全面的抽样研究。 [ABSTRACT FROM AUTHOR]

Summary: Atopic dermatitis (AD), commonly known as eczema, is a chronic inflammatory skin disease causing intense itching and/or pain, which can affect the sleep and health‐related quality of life of both the patient and their family. It affects around 10–20% of people in developed countries. Worldwide AD is in the top 50 of most common diseases. Systemic treatment, meaning a medicine that works within the body rather than just being applied to the skin, is used for patients suffering from moderate‐to‐severe AD, and for whom topical (applied to the skin) treatment is insufficient. Long‐term evidence of most systemic treatments is lacking, especially of off‐label (that is not registered for AD) prescribed methotrexate (MTX) and azathioprine (AZA). This study, from the Netherlands, aimed to find out if MTX and AZA are effective and safe treatments in the long‐term. Patients participated in a follow‐up study of a randomized controlled trial (a study which compares different treatments in actual patients) in which they were seen every 3 months for 5 years. MTX and AZA doses could be in‐ or decreased if the patients’ doctors felt it necessary. The measure how effective the treatments were, the researchers used scoring systems that allowed them to compare symptoms after 5 years compared with when the patients started treatment – in this case, the SCORing Atopic Dermatitis (SCORAD) index in which a reduction in the score shows an improvement in symptoms, and Investigator Global Assessment (IGA). Adverse events (unwanted side effects) were also investigated. Drug survival (that is how long a patient is on treatment) was also analysed. Thirty‐five of 43 originally included patients participated in this follow up study, of which 27 completed the whole 5 years follow up. At year 5, mean relative reduction in SCORAD index was similar in MTX and AZA group: 52.8% and 53.8%. Twelve serious adverse events occurred in 5 years; for three the treatment was the possible cause. Drug survival was longer for MTX, but low in both groups after 5 years (MTX n = 5, AZA n = 1). Based on this relatively small study, MTX and AZA seem to be effective and safe as maintenance treatments in moderate‐to‐severe AD up to 5 years. Few patients in both groups stayed on their originally allocated drug, although some stopped taking the treatment because their symptoms had cleared. This low drug survival underlines the need for effective treatments for AD patients. Further, more long‐term and good sampled studies are needed. [ABSTRACT FROM AUTHOR]

Summary: Clinical trials are needed to find out whether drugs or other treatments work for people with skin diseases. People who take part in a clinical trial are often put into two groups. One group gets the test treatment and the other gets the control treatment. After the treatment has been tried over a period of time, the effect of the treatment in both groups is compared. The more the disease has improved, and the fewer the side effects, the better the treatment. It is very important to measure a person's response to treatment correctly, or else the study conclusions are useless. For instance, itch can be measured by asking the patient directly or by a doctor looking at scratch marks. Both “outcomes” give different information. It is equally important that researchers include the same outcomes when doing clinical trials in similar patient groups. In the field of atopic eczema for instance, it would be very difficult to compare the results of different treatments if one only measured skin redness, another measured itch and another measured only quality of life. You would think that by now, researchers over the world would have got together to sort our which outcomes should always be measured in certain skin diseases. But the reality is that everyone measures different things, making it almost impossible to combine the studies into something that makes sense. Now, a group of researchers, patients, and other experts are finally getting together to discuss how to best measure the treatment effects (or outcomes) in clinical trials of people with skin diseases. At an international meeting in Germany in January 2017, there was agreement about the best way to choose the “core” outcomes by looking at the best evidence and by asking lots of people. But some other things, such as how to best involve patients in making such decisions and how to reach agreement within a larger group of experts, turned out to be more tricky. The international CSG‐COUSIN group are committed to following through their work and hope to come up with a set of core outcomes that should always be measured in people with different skin diseases, so that patients, doctors, nurses and those who pay for healthcare can make better sense of the hundreds of clinical trials that are being done today. [ABSTRACT FROM AUTHOR]

Summary: 皮肤疾病(银屑病)的重要并发症之一就是指甲外观的变化。这些变化包括指甲表面形成小坑、疼痛的指甲板与基础甲床的分离,以及指甲本身的增大和增厚。考虑到外观的各种变化,研究人员在评估治疗结果时应使用简单但准确的标准来衡量治疗的银屑病指甲的变化;这称为核心结果集合。这篇由来自荷兰阿姆斯特丹大学和奈梅亨大学皮肤医学系的调查人员组织的研究调查了65项专注于指甲银屑病的临床试验,所有这些试验均采用了评估措施来衡量银屑病指甲的变化,其中最普遍的措施称为指甲银屑病严重程度指标。然而他们发现,各种研究中使用了若干不同的方法。一项针对这些研究的详细分析指出了这些方法中的许多差异,这导致不同治疗的结果难以进行比较。这尤其是因为缺乏用于表述研究中发现的指甲疾病严重程度最终分数的标准方法,而且严重程度的不同方面的评级也都不相同。其中一些评估打分系统甚至没有经过验证(证实)。作者们呼吁业界重新考虑所使用的银屑病指甲评估方法并重点指出需要开发能够经得起检查的新方法。这些方法应使调查人员能够以标准的方法评估病甲中的不同变化,从而使不同研究的结果具备可比性。他们建议组建一个共识小组来执行此项工作。 [ABSTRACT FROM AUTHOR]