Assessment and Monitoring of the Wound Micro-Environment in Chronic Wounds Using Standardized Wound Swabbing for Individualized Diagnostics and Targeted Interventions.

Background/Objectives: Patient-specific diagnostic and therapeutic approaches are important in the care of people with chronic wounds. The heterogeneity of underlying disease profiles and the diversity of the wound micro-environment make generalized approaches difficult. While high-throughput molecular diagnostic methods are increasingly widespread and available, the analysis of objective biomolecular disease patterns has not found its way into everyday wound management. The aim of this study is to evaluate the use of wound swab samples for the analysis of biomarkers and disease patterns in people with chronic wounds. Methods: A sample cohort from the multicenter "Wound-BIOME" project was analyzed. The project aims to comprehensively investigate the local micro-environment of chronic wounds of various entities, healing tendencies and regeneration stages at the biomolecular level. A sample collection and handling protocol suitable for everyday use was tested and evaluated regarding feasibility for multiplex immunoassay, proteomics, small RNA sequencing (miRNA) and metagenome analyses (microbiomics). Results: It could be shown that standard wound swabs are well-suited for the analysis of the complex wound micro-environment using various high-throughput methods. Despite the sample heterogeneity, the quality was adequate to analyze biomolecular patterns. Conclusions: Initial analyses of protein signatures, microbial wound communities and miRNA patterns show promising results for future individualized diagnostics and targeted interventions.

Epidemiology and Healthcare of Juvenile and Late-Onset Acne: Claims Data Analysis.

INTRODUCTION: Acne is the most frequent chronic inflammatory skin condition in adolescence but occurs also in later age. Our study aimed to characterise the epidemiology, geographical distribution, comorbidity and healthcare of acne juvenilis (AJ) and acne tarda (AT). METHODS: Statutory health insurance (SHI) data from 2016 to 2020 were analysed. Prevalence rates, including geographical distribution, comorbidities and drug use by specialists group, were measured. RESULTS: In 2020, the prevalence of acne among adults was 1.50% (AT > 25 years) and among adolescents was 3.88% (AT ≤ 25 years). The highest prevalence (13.02%) was observed at the age of 17 years. Sex differences were higher in AT (73.80% in women) than in AJ (64.55% in women). Compared with non-affected persons, individuals with acne - in particular with AT - showed significantly higher rates of skin-related comorbidities, including folliculitis (rate ratio (RR) 8.89), pyoderma (RR 7.27) and rosacea (RR 5.53), and non-skin-related comorbidities, such as ovarian dysfunction (RR 2.36), rhinitis allergica (RR 1.84) and Crohn's disease (RR 1.79). Preferred systemic therapeutics prescribed were anti-infectives in AT (46.86%) and retinoids in AJ (52.35%). In the majority of cases, dermatologists were involved in the treatment of acne (AT 65.77%; AJ 76.27%). The most commonly prescribed topical agents were adapalene with benzoyl peroxide (AT 87.72%; AJ 85.75%), while systemic isotretinoin (AT 81.20%; AJ 90.06%) was also a frequently used drug. General practitioners were more likely to prescribe anti-infectives, especially topical antibiotics such as chlortetracycline (AT 52.38%; AJ 44.44%) and systemic antibiotics, especially tetracycline (AT 58.33%; AJ 67.50%). CONCLUSION: Acne affects a relevant proportion of the German population not only in adolescence, and management of this inflammatory skin disease does not naturally follow medical guidelines or specialist recommendations. These findings emphasise the importance of specialised care and comprehensive therapeutic management that should also consider the exploration of comorbidities.

We performed an analysis on the frequencies of illness and concomitant diseases of acne in Germany based on health insurance data. Furthermore, the treatment of acne in regard to drug choices and prescribers was characterised. In 2020, about 2 million people in Germany had acne. The mean age was 31 years, and women were more often affected (68.58%). The highest proportion of acne was observed at the age of 17 years (13.02%). Overall, adolescent acne (younger than 25 years) was more frequent than adult acne (older than 25 years). People with acne, especially with adult acne, had higher rates of concomitant diseases (compared with non-affected persons, both related to the skin and beyond). About a third of people with acne were not treated by a dermatologist, and the majority of these patients were not treated according to guidelines. In conclusion, acne and related concomitant diseases affect a relevant proportion of adolescents and adults in Germany. The high prevalence of adult acne suggests a special focus also on this age group, including exploration of hormonal and psychological disorders. Early and effective treatment, adapted to the severity of the acne, can prevent complications such as scarring.

Vaccination Rates in Patients with Chronic Inflammatory Skin Diseases and Immunomodulatory Systemic Therapies-Vaccinations against SARS-CoV-2, Influenza Virus or Varicella Zoster Virus.

INTRODUCTION: The national guidelines and the Standing Committee on Vaccination (STIKO) of the Robert Koch Institute (RKI) in Germany support preventive vaccinations for patients under immunomodulatory treatments. MATERIAL AND METHODS: Retrospective analysis of data from patients with chronic inflammatory skin diseases from December 2021 to December 2022 with a focus on preventive vaccinations against influenza virus, varicella zoster virus, or SARS-CoV-2. RESULTS: Patients with chronic inflammatory skin diseases were referred to our university outpatient's clinic for recommendations of systemic therapy. Vaccinations against influenza virus, varicella zoster virus, or SARS-CoV-2 were documented in 7365 analyzed patient files. A total of 79.7% were completely vaccinated against SARS-CoV-2, 49.7% patients were vaccinated against the influenza virus, and only 9.2% were completely vaccinated against varicella zoster virus. DISCUSSION: In our patients who came for counselling before or during systemic treatment, vaccination rates against SARS-CoV-2, varicella zoster virus, or influenza virus were low. Patients age 60 and above had higher rates than the average German population of the same age, but still no satisfying protection. CONCLUSIONS: We suggest informing patients about preventive vaccination before and during systemic immunomodulatory treatments and emphasize the need for active communication in this vulnerable patient group.

Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis.

INTRODUCTION: With newer biologics, the achievement of complete skin clearance has become an attainable treatment goal for patients with plaque psoriasis. We evaluate how improvements in Psoriasis Area and Severity Index (PASI) responses, particularly at incremental improvements approaching complete skin clearance (PASI 100), translate into improvements in health-related quality of life (HRQoL) and patient-perceived symptoms. METHODS: Data from the BE RADIANT phase 3b trial (NCT03536884) and its open-label extension (OLE), pooled across all study visits and treatments over 16 weeks (randomised patients) and 2 years (patients entering the OLE), were analysed using mixed-effects logistic regression models. Proportions of patients achieving a Dermatology Life Quality Index (DLQI) of 0/1, DLQI item scores of 0, and Psoriasis Symptoms and Impacts Measure (P-SIM) item scores of 0 for itching, scaling, and skin pain at specific PASI improvement levels were estimated. RESULTS: Seven hundred and forty-three patients were randomised to treatment; 654 entered the OLE. Using 16-week pooled data, there were incremental improvements in the proportions of patients estimated by our model to achieve DLQI 0/1 with PASI 100 compared with 95% (PASI = 95%) and 90% (PASI = 90%) improvements in PASI (93.0%, 89.3%, and 83.8% achieving DLQI 0/1, respectively). Estimated proportions achieving DLQI item scores of 0 had the greatest increases at higher PASI improvement levels for Items 1 (itchy, sore, painful, or stinging skin), 2 (embarrassment), and 4 (choice of clothing). Estimated proportions of patients achieving P-SIM = 0 were also higher for PASI 100 (itching: 61.7%; scaling: 82.2%; skin pain: 96.9%) than for PASI = 95% (50.8%; 72.3%; 95.7%) and PASI = 90% (39.8%; 59.5%; 94.0%). Similar benefits of incremental PASI improvements were estimated using 2-year data. CONCLUSIONS: Complete skin clearance translated into the greatest benefits to HRQoL and patient-perceived symptoms, over and above skin clearance between 90% and 100%, highlighting the importance of targeting PASI 100 as a treatment outcome for patients with psoriasis. TRIAL REGISTRATION NUMBER: NCT03536884. Complete skin clearance is associated with the greatest benefits to health-related quality of life and perceived symptoms for patients with psoriasis: KeyResults and Conclusions (MP4 72828 kb).

Healthcare of patients with atopic dermatitis by general practitioners - a nationwide survey in Germany.

BACKGROUND AND OBJECTIVES: Epidemiological studies on the health care of patients with atopic dermatitis (AD) in dermatological treatment in Germany indicate no improvements within 10 years. In addition to dermatologists, general practitioners (GPs) are particularly involved in AD treatment. This study analyzed the health care situation of adult patients with AD by GPs. PATIENTS AND METHODS: The cross-sectional questionnaire survey "PsoADA" was conducted from 2019 to 2021 in general practices throughout Germany and the results were compared with previous data from dermatology care (AtopicHealth2, 2017-19). RESULTS: Among 150 patients (mean age: 40 years, 62.2% female), 39.2% received additional treatment by a dermatologist (GP+D). 20.7% of GP+D and 5.7% of patients in GP treatment only (GP only) had severe AD (p < 0.01, AtopicHealth2: 27.6%). Major limitations in quality of life were reported by 31.0% (GP+D) versus 3.4% (GP only) (p < 0.001, AtopicHealth2: 31.6%). Most patients received topicals, mainly glucocorticosteroids. Calcineurin inhibitors were currently administered by 2.7% (PsoADA total). Patient education was reported by 5.7% (PsoADA total). CONCLUSIONS: A considerable proportion of patients with AD in GP care shows poor outcomes, as has been observed in dermatological care - possibly due to the lack of use of modern systemic therapy.

Exploring Acceptability, Barriers, and Facilitators for Digital Health in Dermatology: Qualitative Focus Groups With Dermatologists, Nurses, and Patients.

BACKGROUND: Although several digital health interventions (DHIs) have shown promise in the care of skin diseases their uptake in Germany has been limited. To fully understand the reasons for the low uptake, an in-depth analysis of patients' and health care providers' barriers and facilitators in dermatology is needed. OBJECTIVE: The objective of this study was to explore and compare attitudes, acceptability, barriers, and facilitators of patients, dermatologists, and nurses toward DHIs in dermatology. METHODS: We conducted 6 web-based focus groups each with patients (n=34), dermatologists (n=30), and nurses (n=30) using a semistructured interview guide with short descriptions of DHIs described in the literature. A content analysis was performed using deductive constructs, following the unified theory of acceptance and use of technology framework, and inductive categories. RESULTS: Patients identified many positive performance expectancies, such as reduced travel times and improvement in follow-up appointments. Dermatologists also stated positive effects (eg, promotion of standardized care), but also negative implications of health care digitalization (eg, increased workload). All stakeholders reported that a DHI should bring additional value to all stakeholders. A lack of digital competence among patients was identified as the major barrier to adoption by all 3 groups. Nurses and dermatologists want apps that are easy to use and easy to implement into their daily routines. Trust in selected institutions, colleagues, and physicians was identified as a facilitator. Patients reported their dependence on the dermatologists' acceptance. All groups expressed concerns about data privacy risks and dermatologists stated insecurities toward data privacy laws. CONCLUSIONS: To ensure successful digitalization in dermatology, apps should be user-friendly, adapted to users' skill levels, and beneficial for all stakeholders. The incorporation of dermatologists' perspectives is especially important as their acceptance may impact use among patients and nurses. DHIs should ensure and be transparent about data privacy. The found barriers and facilitators can be used for implementation strategies.

Patient needs in women of childbearing age with psoriasis: retrospective analysis from the German PsoBest registry.

Background: Women of childbearing age (WoCBA) with psoriasis face additional burden related to contraindications of systemic treatments during pregnancy/lactation and to the physical and psychosocial impact of psoriasis on their intimate/sexual relationships. Objective: Within a people-centered health care model, this study aimed to identify specific patient needs and their correlates in WoCBA (18-45 years), in comparison to same-age men and women above 45 years. Methods: Baseline data from the German PsoBest registry, including patients with moderate/severe plaque-type psoriasis with the indication for systemic therapy, were retrospectively analyzed. Psoriasis severity was assessed with the Psoriasis Area and Severity Index and patient-reported outcomes included EuroQoL Visual Analogue Scale, Dermatology Life Quality Index (DLQI), and Patient Needs Questionnaire. Results: The participants were 2308 WoCBA, 3634 men between 18 and 45 years of age, and 3401 women older than 45 years. In comparison to both control groups, WoCBA reported more DLQI impairments and higher needs to reduce social impairments (eg, "to be able to lead a normal working life"; "to be less burdened in your partnership"; "to be able to have a normal sex life"). These patient needs were associated with having psoriasis arthritis, previous systemic therapy, worse general health, and more DLQI impairments. Limitations: Retrospective analysis of an established dataset limited the examination of specific developmental, sexual, and reproductive variables. Conclusion: The specific needs of WoCBA with psoriasis were particularly related to the work context/financial stability and intimate relationships, which are crucial aspects in family planning. These results claim for a sex/age-sensitive approach in the psoriasis health care, by considering these needs as qualifiers in the clinical decision for systemic treatment.

Effects of a skin type diversity seminar on undergraduate medical students' self-assessed competence in managing skin diseases in patients with skin of color.

BACKGROUND: Skin diseases in patients with skin of colour (Fitzpatrick skin types IV to VI) are underrepresented in dermatology training, which may lead to lower quality of care for these patients. To address this underrepresentation in medical education, a newly developed seminar on skin type diversity using an interactive teaching method was implemented in an undergraduate medical curriculum. This study examined the effects of a seminar on the self-assessed competence of medical students in managing skin conditions in patients with skin of colour. METHODS: A questionnaire survey was conducted among fourth-year undergraduate medical students at the University of Hamburg (Germany) between October 2023 and February 2024. Students' self-assessed competence was compared before and after the obligatory seminar (pre- and post-design). RESULTS: In total, 158 students participated in the survey. After the seminar, knowledge of the presentation of skin diseases in patients with skin of colour and the associated psychological burden, differences in the incidence of skin diseases in different skin types, and the ability to diagnose skin diseases in darker skin types increased. Most participants stated that they wanted to attend more courses on this topic. DISCUSSION: Appropriate courses for medical students can improve their competence in managing different skin diseases in patients with skin of colour. In the future, more attention should be paid to teaching the diversity of skin types in dermatology education.

Development, Feasibility, and Acceptability of the Electronic Patient Benefit Index for Psoriasis in Clinical Practice: Mixed Methods Study.

BACKGROUND: Patient-reported outcomes are relevant in clinical practice showing patient benefits, supporting clinicians' decision-making, and contributing to the delivery of high standards of care. Digital monitoring of patient-reported outcomes is still rare. The Patient Benefit Index (PBI) measures benefits and goals from patients' views and may be relevant for regular documentation and shared decision-making. OBJECTIVE: This study aimed to develop electronic versions of the PBI to examine their feasibility and acceptability in clinical practice for patients with psoriasis. METHODS: We developed an app and a web version of the existing, valid PBI using focus groups and cognitive debriefings with patients before conducting a quantitative survey on its feasibility and acceptability. Conduction took part in an outpatient dermatology care unit in Germany. Descriptive and subgroup analyses were conducted. RESULTS: A total of 139 patients completed the electronic PBIs (ePBIs) and took part in the survey. The ePBI was understandable (n=129-137, 92.8%-98.6%) and feasible, for example, easy to read (n=135, 97.1%) and simple to handle (n=137, 98.5%). Acceptability was also high, for example, patients can imagine using and discussing the ePBI data in practice (n=91, 65.5%) and documenting it regularly (n=88, 63.3%). They believe it could support treatment decisions (n=118, 84.9%) and improve communication with their physician (n=112, 81.3%). They can imagine filling in electronic questionnaires regularly (n=118, 84.9%), even preferring electronic over paper versions (n=113, 81.2%). Older and less educated people show less feasibility, but the latter expected the relationship with their physician to improve and would be more willing to invest time or effort. CONCLUSIONS: The app and web version of the PBI are usable and acceptable for patients offering comprehensive documentation and patient participation in practice. An implementation strategy should consider patients' needs, barriers, and facilitators but also physicians' attitudes and requirements from the health care system.

Assessing health-related quality of life using the Wound-QoL-17 and the Wound-QoL-14-Results of the cross-sectional European HAQOL study using item response theory.

For assessing health-related quality of life in patients with chronic wounds, the Wound-QoL questionnaire has been developed. Two different versions exist: the Wound-QoL-17 and the Wound-QoL-14. For international and cross-cultural comparisons, it is necessary to demonstrate psychometric properties in an international study. Therefore, the aim of this study was to test both questionnaires in a European sample, using item response theory (IRT). Participants were recruited in eight European countries. Item characteristic curves (ICC), item information curves (IIC) and differential item functioning (DIF) were calculated. In both questionnaires, ICCs for most items were well-ordered and sufficiently distinct. For items, in which adjacent response categories were not sufficiently distinct, response options were merged. IICs showed that items on sleep and on pain, on worries as well as on day-to-day and leisure activities had considerably high informational value. In the Wound-QoL-14, the item on social activities showed DIFs regarding the country and age. The same applied for the Wound-QoL-17, in which also the item on stairs showed DIFs regarding age. Our study showed comparable results across both versions of the Wound-QoL. We established a new scoring method, which could be applied in international research projects. For clinical practice, the original scoring can be maintained.

Epidemiology and health care of hyperhidrosis in Germany: claims data analysis.

BACKGROUND AND OBJECTIVES: Data on the population-based epidemiology of hyperhidrosis (HH) are scarce. This study investigated the epidemiology and healthcare of HH in Germany. DESIGN AND SETTING: Claims data of adult persons insured by a German statutory health insurance (DAK-Gesundheit) between 2016 and 2020 were analysed. Included were persons aged 18 years and older with a diagnosis of HH (confirmed inpatient or outpatient diagnosis in the observation year) who were continuously insured. Following outcomes were measured: prevalence and incidence rates, severity of hyperhidrosis and inpatient and outpatient care by a group of specialists. RESULTS: In 2020, 0.70% of insured adults were confirmed to have HH (mean age 59.5 years, SD 18.9, 61.6% female), with 9.24% having a 'localised' form, 8.65% a 'generalised' form and 84.80% an 'unspecified' form. 0.04% of the total population had a severe form. The incidence was 0.35%. Localised HH was more common in younger age groups (18 to <30 years), while older age groups (70 to <80 years) were significantly more likely to suffer from generalised HH. Systemic anticholinergics were used in 4.55%, and botulinum toxin injection therapy in 0.81%. General practitioners were most frequently involved in care. Inpatient stays due to HH were very rare, with 0.14% in 2019 and 0.04% in 2020. CONCLUSION: Multisource data analysis connecting primary and secondary data will be needed for a complete picture of the healthcare and epidemiology of HH.

Treatment adjustment in biologic therapies for moderate-to-severe plaque psoriasis: a German retrospective chart review (TABU).

BACKGROUND AND OBJECTIVES: Flexible biologic therapy dosing regimens in psoriasis management are common, but data from routine care in Germany are scarce. This study evaluated treatment adjustments for biologic therapies commonly prescribed in Germany. PATIENTS AND METHODS: Charts for up to 100 consecutive patients treated at 29 centers were reviewed. Data were extracted for adults (aged 18-65 years) with moderate-to-severe plaque psoriasis treated with adalimumab, guselkumab, ixekizumab, secukinumab, or ustekinumab for ≥ 36 weeks. The primary endpoint was time to first treatment adjustment. Secondary endpoints included frequency of and reasons for treatment adjustments. Time to treatment adjustment was analyzed using Kaplan-Meier methods. RESULTS: Among 982 patients, 297 treatment adjustments in 240 (24.4%) patients were identified. The mean (median; interquartile range) time to first treatment adjustment (n = 223) was 8.4 (4.0; 2.0-12.0) months (secukinumab: 14.1 [10.0; 4.0-21.0], adalimumab: 11.0 [7.0; 3.0-14.5], ustekinumab: 11.0 [6.0; 2.0-16.0], ixekizumab: 5.8 [3.0; 2.0-8.5], guselkumab: 5.1 [3.0; 2.0-7.0]). The most frequent adjustment type was starting concomitant treatment(s) (10.4% of patients); insufficient skin effectiveness was the most frequent reason for adjustment. CONCLUSIONS: Biological treatment adjustments are frequent in moderate-to-severe psoriasis; flexible dosing regimens would support optimal management.

Basic Susceptibility of Patients with Psoriasis under Systemic Therapy for Respiratory Infections: Data from the German Psoriasis Registry PsoBest.

Background: Patients with psoriasis under systemic treatments are in focus regarding their susceptibility to respiratory infections. To analyse real-world data for respiratory infections in patients with psoriasis under systemic treatments. Methods: We analysed data of the prospective, non-interventional German Psoriasis Registry PsoBest and compared rates for respiratory infections of 13,823 patients on systemic treatments for psoriasis and/or psoriatic arthritis in different therapy cohorts before the COVID-19 pandemic. Results: In total, 1415 respiratory infections were observed in 970 patients. Significant differences were observed between biologics and non-biologics, but not within these groups. The highest event rates (events/100 patient years) were identified for TNF-α inhibitors, 8.1, (CI 7.4-8.9), followed by 7.0 for IL-17 inhibitors (6.2-7.9), 5.7 for IL-12/23 and IL-23 inhibitors (5.1-6.5), 4.8 for methotrexate (4.3-5.4), 3.7 for small molecules (3.3-4.2), and 2.7 for retinoids (1.2-5.1). Conclusions: Overall, the susceptibility for respiratory infections in patients under systemic therapy for psoriasis is low compared to published study data and is sufficient as comparative data for COVID-19 studies.

Quality of life measurement in assessing treatment effectiveness in urticaria: European experts position statement.

In this study, the European Academy of Dermatology and Venereology (EADV) Task Forces on Quality of Life and Patient-Oriented Outcomes and Urticaria and Angioedema has examined the Health-Related Quality of Life (HRQoL) measurement in the treatment of urticaria. The Dermatology Life Quality Index was the most frequently used HRQoL instrument in clinical trials on urticaria. Many reports of clinical trials of urticaria gave no exact numeric results related to HRQoL changes, making clear conclusions and comparisons with other studies impossible. The interpretation of HRQoL impairment data is more difficult when assessed by instruments without severity stratification systems. The minimal clinically significant difference (MCID) is a more clinically oriented and relevant parameter than depending on statistically significant changes in HRQoL scores. Therefore, using HRQoL instruments with established MCID data in clinical trials and clinical practice is preferred.

Skin cancer in Germany: Characterising screening, prevalence and mortality from a spatial perspective.

Aim of the study was to characterise the association between screening, prevalence and mortality of skin cancer in Germany considering the spatial distribution. The study included the total set of outpatient data of all statutory health insured people and cause-of-death statistics in Germany between 2011-2015 on county level. To identify regions with high/low screening, prevalence and mortality rates, probability maps were calculated. Scenarios were developed based on the research questions. These were used to identify regions that share both high/low rates of screening, prevalence and mortality. Regression analyses were used to characterise these regions, taking into account sociodemographic characteristics. Significant regional variations in prevalence, screening and mortality in Germany were identified. Depending on the scenario, influences of sociodemographic conditions become apparent. For example, a lower income (p = 0.006) and poorer accessibility of the closest dermatologist (p = 0.03) predicted a lower prevalence of and fewer screenings for skin cancer. In regions with low screening and high mortality, significant (p = 0.03) associations with the educational status of the population were also found. The study identified the first spatial associations between screening, prevalence and mortality of skin cancer in Germany. The results indicate that regional population-related characteristics (e.g., sociodemographic characteristics) play an important role in explaining the associations and should be given more weight in further studies. However, further studies, particularly on the spatial variation of skin cancer mortality, are still necessary.

Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials.

INTRODUCTION: Deucravacitinib, a novel, oral, selective allosteric tyrosine kinase 2 inhibitor, demonstrated superiority versus placebo and apremilast in the POETYK PSO-1 and PSO-2 studies. We describe patient-reported outcomes with deucravacitinib treatment versus placebo and apremilast in these studies. METHODS: Two multicenter, global, double-blind, placebo- and active comparator-controlled studies randomized patients with moderate-to-severe plaque psoriasis 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Score changes from baseline and meaningful within-patient change responses for Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) were assessed. RESULTS: In POETYK PSO-1 (n = 666) and PSO-2 (n = 1020), respectively, improvement from baseline in PSSD total score was greater with deucravacitinib (- 27.8 and - 30.1) versus placebo (- 4.4 and - 5.9) and apremilast (- 18.9 and - 22.5) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 32.8 and - 30.7; apremilast: - 21.6 and - 22.8) (nominal p < 0.0001). Improvement from baseline in DLQI score was also greater with deucravacitinib (- 8.5 and - 7.6) versus placebo (- 3.3 and - 3.0) and apremilast (- 5.9 and - 5.8) at Week 16 and versus apremilast at Week 24 (deucravacitinib: - 8.6 and - 7.5; apremilast: - 5.6 and - 5.5) (nominal p < 0.0001). Achievement of meaningful within-patient change in PSSD total score and in DLQI score occurred more frequently with deucravacitinib than placebo and apremilast at Week 16 and versus apremilast at Week 24. CONCLUSIONS: Deucravacitinib demonstrated meaningful improvements in patient-reported outcomes in patients with moderate-to-severe plaque psoriasis compared with apremilast and placebo. CLINICAL TRIAL REGISTRATION: NCT03624127, NCT03611751.

Measurement properties and interpretability of the Patient-Reported Impact of Dermatological Diseases (PRIDD) measure.

BACKGROUND: Patient-reported outcome measures (PROMs) are crucial for assessing the impact of dermatological conditions on patients' lives, but the existing dermatology-specific PROMs are not recommended for use according to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN). We developed the Patient-Reported Impact of Dermatological Diseases (PRIDD) measure in partnership with patients. It has strong evidence of content validity, structural validity, internal consistency, acceptability, and feasibility. OBJECTIVES: To test PRIDD's remaining measurement properties and establish the interpretability of scores against the COSMIN criteria using classic and modern psychometric methods. METHODS: A global longitudinal study consisting of two online surveys administered two to four weeks apart. Adults (≥ 18 years) living with a dermatological condition were recruited through the International Alliance of Dermatology Patient Organizations' (GlobalSkin) membership network. Participants completed PRIDD, a demographics questionnaire, and other related measures including the Dermatology Life Quality Index (DLQI). We tested PRIDD's criterion validity, construct validity and responsiveness (Spearman's ρ, independent-samples t-tests and ANOVA), test-retest reliability (interclass correlation coefficient [ICC]), measurement error (Smallest Detectable Change or Limits of Agreement [LoA], distribution-based Minimally Important Change [MIC]), floor and ceiling effects (number of minimum and maximum scores and Person-Item Location Distribution Maps), score bandings (κ coefficient of agreement) and anchor-based MIC. RESULTS: 504 patients with 35 dermatological conditions from 38 countries participated. Criterion validity (ρ = 0.79), construct validity (76% hypotheses met), test-retest validity (ICC = 0.93), and measurement error (LoA = 1.3 < MIC = 4.14) were sufficient. Floor and ceiling effects were in the acceptable range (< 15%). Score bandings were determined (κ = 0.47), however, the anchor-based MIC could not be calculated due to an insufficient anchor. CONCLUSIONS: PRIDD is a valid and reliable tool to evaluate the impact of dermatological disease on patients' lives in research and clinical practice. It is the first dermatology-specific PROM to meet the COSMIN criteria. These results support the value of developing and validating PROMs with a patient-centred approach and using classic and modern psychometric methods. Further testing of responsiveness and MIC, cross-cultural translation, linguistic validation, and global data collection are planned.

Utilization and related harms of systemic glucocorticosteroids for atopic dermatitis: claims data analysis.

BACKGROUND: Systemic glucocorticosteroids (SGCs) are used in the short-term treatment of atopic dermatitis (AD), but are not recommended for long-term use because they are associated with severe side-effects. OBJECTIVES: This study aimed to characterize the utilization and potentially negative effects of SGC use for AD in German statutory health insurance (SHI) claims data. METHODS: Cross-sectional and longitudinal analysis of a large nationwide SHI dataset. SGC drug prescriptions and incidences of predefined comorbidities after drug initiation that were known to be potentially harmful side-effects were analysed. SGC use was quantified by (-definition 1) the number of quarters with at least one SGC prescription and (definition 2) the defined daily doses (DDD). Comparisons were adjusted for age, sex and morbidity. RESULTS: The AD prevalence was 4.07% in 2020 (4.12% women, 3.42% men). During this period 9.91% of people with AD were prescribed SGCs compared with 5.54% in people without AD (P < 0.01). Prescribing of SGCs was significantly higher in women (10.20% vs. 9.42% in men, P < 0.01) and in the elderly. AD and SGC prevalence varied regionally. In a 3-year follow-up period, 58% of people with AD receiving a SGC were prescribed SGCs in > one quarter and 15% in > six quarters. The odds of developing osteoporosis [odds ratio (OR) 3.90 -(definition 1) and 1.80 (definition 2)] and diabetes [OR 1.90 (definition 1) and 1.38 (definition 2)] were significantly higher in people with AD on SGCs, especially in the frequently prescribed group compared with the rarely prescribed group, regardless of quantified use. CONCLUSIONS: A considerable number of people with AD in Germany are prescribed long-term SGCs. The onset of medical conditions known to be harmful effects of steroids was significantly more frequent in those who were frequently prescribed SGCs, indicating the need for optimized healthcare.

Atopic dermatitis (AD) is a condition that causes severe itching and dry skin. AD is common and affects almost 100 000 people in Germany. The treatment for AD with systemic glucocorticosteroids (SGCs) should be limited to short-term use, typically lasting up to 3 weeks during periods of acute flares. This study aimed to investigate how often and for how long people with AD in Germany use SGCs and whether there are any adverse effects associated with their use, using data from health insurance claims. We found that a significant number of people with AD were frequently prescribed SGCs for prolonged periods of time, which could increase the risk of side-effects such as osteoporosis, diabetes, gastritis, depression and oesophageal reflux. Overall, our study findings highlight the importance of reducing the overuse of SGCs and advocate the use of approved long-term medications for people with AD, to reduce the risks of harmful side-effects.

Effect of oral multispecies probiotic on wound healing, periodontitis and quality of life on patients with diabetes.

OBJECTIVE: Hard-to-heal (chronic) wounds are common in patients with diabetes and are associated with a decrease in quality of life (QoL). Pathogenic bacteria often colonise hard-to-heal wounds and hinder the healing process which poses a high risk for (systemic) infections. In this study, we aim to prove that probiotics are capable of displacing human pathogenic bacteria, ameliorating inflammation and positively influencing the microenvironment/microbiome of skin and mucosa. METHOD: In this pilot study, patients with diabetes and hard-to-heal wounds with a duration of 2-120 months received an oral multispecies probiotic daily for six months. Changes in oral, stool and wound microbiome were investigated, and the effects of the probiotic intervention on wound healing, periodontitis and wound-specific quality of life (Wound-QOL-17) were analysed throughout the course of this clinical study. RESULTS: In total, seven of the 20 patients included were unable to complete the study. After six months of oral probiotic intake supplementation in five out of the remaining 13 patients, the wounds had healed completely. Most patients reported an improvement in wound-specific QoL, with particular positive effects on pain and mobility. Microbiome analysis revealed a reduction in Staphylococcus aureus and Pseudomonas aeruginosa, and Staphylococcus epidermis in healed wounds. CONCLUSION: This findings of this study provide evidence for the beneficial effects of the oral application of a multispecies probiotic over six months in patients with diabetes and hard-to-heal wounds on wound closure, wound microbial pattern, QoL, and on dental health. A randomised, placebo-controlled, double-blinded clinical trial is required to verify the results.