SCORing Atopic Dermatitis Research Articles

354 Genital involvement in patients with atopic dermatitis is associated with sexual difficulties and higher disease burden: results from a real-world multicountry cohort study (MEASURE-AD)

Abstract Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease characterized by erythematous and pruritic lesions. Genital involvement of AD is not well characterized or studied; the prevalence of genital AD and its impact on sexual function and quality of life has not been fully elucidated. To evaluate disease burden and quality of life among patients with genital involvement of AD. MEASURE-AD is a cross-sectional, non-interventional cohort study enrolling subjects from 28 countries to assess the disease burden associated with moderate-to-severe AD. Patients aged ≥12 years with a physician-confirmed diagnosis of moderate-to-severe AD who were receiving or eligible to receive systemic therapy were enrolled between December 2019 and December 2020 during routine clinic visits. Patients ≥16 years were included in this post-hoc analysis. Genital involvement was identified using the SCORing Atopic Dermatitis (SCORAD) index. The extent and severity of AD were evaluated using the Eczema Area and Severity Index (EASI), body surface area (BSA) and the validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD). Pruritus was assessed using the Worst Pruritus Numeric Rating Scale (WP-NRS). Quality of life assessments were conducted using the Dermatology Life Quality Index (DLQI)/Children’s DLQI (CDLQI). Association between burden and genital AD was analysed by applying Kruskal-Wallis and Chi-square tests to continuous and categorical variables, respectively. In the MEASURE-AD study, 1474 patients (708 females [48.0%]; 766 males [52.0%]) were enrolled with a mean (SD) age of 38.0 (16.5) years and AD duration of 23.3 (15.4) years. A total of 245 patients (16.6%) were identified as having genital AD; 1229 (83.4%) had no genital AD involvement. Patients with genital AD had significantly higher EASI (mean [SD]: 23.5 [13.7] vs. 13.1 [12.0]) and WP-NRS (6.4 [2.6] vs. 5.1 [3.1]) scores (P < 0.0001 for both), a greater number of AD regions affected (three other regions affected: 94.7% vs. 60.5%; P < 0.0001), greater body surface area involvement (mean [SD]: 40.9% [24.7] vs. 21.5% [20.72]; P < 0.0001), and more severe disease (vIGA-AD score of 4: 31.8% vs. 17.6%; P < 0.0001) than patients without genital AD. Patients with genital AD had greater impairment in quality of life compared with those without genital involvement (DLQI mean [SD]: 13.9 [7.4] vs. 10.1 [7.7]; P < 0.0001). Specifically, more patients with genital AD experienced sexual difficulties than those without genital AD (DLQI sexual difficulties, a lot/very much: 37.8% vs. 18.4%; P < 0.0001). Patients with genital AD experienced a higher disease burden and greater impairment of quality of life with a considerable impact on sexual function compared with patients without genital involvement. Healthcare providers should proactively inquire about genital AD symptoms as some patients may be hesitant to raise the topic out of embarrassment or fear of judgment. Effective treatment is important for mitigating the multidimensional burden of AD; the burden of genital AD should be considered during treatment decision-making discussions between patients and healthcare providers.

Itching in Atopic Dermatitis: Patient- and Physician-reported Outcomes in the German Atopic Dermatitis Registry TREATgermany.

TREATgermany is an investigator-initiated prospective disease registry. It investigates physician- and patient-reported disease severity (Eczema Area and Severity Index (EASI), objective Scoring Atopic Dermatitis (oSCORAD), Investigator Global Assessment, Patient-Oriented Eczema Measure (POEM), Patient Global Assessment (PGA)), patient-reported symptoms (itch, sleep loss, depressive symptoms), therapy courses and dermatological quality of life (DLQI) in moderate-to-severe atopic dermatitis with SCORAD > 20. 1,134 atopic dermatitis patients (mean age 41.0 ± 14.7 years, 42.5% females) were enrolled by 40 German recruiting sites (dermatological clinics and practices) between June 2016 and April 2021. The current analysis focuses on itch scores obtained with a numerical rating scale (NRS)) documented for the previous 3 days prior to baseline visit. The results show that 97.2% (1,090 of 1,121) patients experienced itch. Itch severity correlated moderately with severity of atopic dermatitis oSCORAD (rho = 0.44 (0.39-0.48)) and EASI score (rho = 0.41 (0.36-0.46)). A strong correlation was found with self-reported disease severity as PGA (rho = 0.68 (0.65-0.71)), POEM sum score (rho = 0.66 (0.63-0.69)) and dermatological quality of life impairment DLQI (rho = 0.61 (0.57-0.65)). Itch as a subjective complaint is more closely correlated with patient-reported outcomes than with objective assessments by the physician.

Association of Adult Atopic Dermatitis Severity With Bacterial, Viral, and Fungal Skin Infections.

Background: Little is known about the relationship of atopic dermatitis (AD) severity, phenotype, and persistence on different types of skin infections. Objective: To evaluate the relationship of AD characteristics and skin infections over time in adults. Methods: We performed a prospective dermatology practice-based study (n = 559). History of infection was assessed using questionnaires. AD severity was evaluated using Scoring Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), and Patient-reported Global Assessment (PtGA). Results: At baseline, 160 (21.4%) patients reported history of ≥1 skin infection, including 14.3% with bacterial infections. In multivariable repeated measures logistic regression models, ≥1 cutaneous infection was associated with moderate (adjusted odds ratio [95% confidence interval]: 2.67 [1.67-4.28]) and severe (6.35 [3.36-12.01]) versus mild SCORAD; as well as severe SCORAD-itch; moderate and severe versus clear-mild EASI; moderate and severe versus clear-mild PtGA; mild, moderate, and severe versus clear-almost clear IGA. Cutaneous infections were not associated with ichthyosis, palmar hyperlinearity, nummular eczema, cheilitis, or hand eczema. Specific infections varied by AD severity and body site. Persistent moderate-severe disease was associated with higher odds of skin infection. Conclusion: Skin infections were associated with AD severity but not phenotype, and may be mitigated by improved AD severity.

Clinical experience of using the Children’s Dermatology Life Quality Index in children with atopic dermatitis

Background. Atopic dermatitis is a common pruritic skin disease that causes a significant burden on patients, their families, and society. The purpose of this work was to evaluate the quality of life of children with atopic dermatitis and to study the correlation between the severity of atopic dermatitis and the quality of life according to the Children’s Dermatology Life Quality Index (CDLQI). Materials and methods. Patients with atopic dermatitis (n = 71) aged 4–17 years from the allergy department of the Kyiv City Children’s Clinical Hospital No. 2 were included in the study. The severity of atopic dermatitis was assessed by the SCORing Atopic Dermatitis (SCORAD) tool, and the quality of life — by the CDLQI. Spearman’s rank correlation coefficient was used for correlation analysis of the CDLQI and the SCORAD indicators. Correlation was considered probable at p < 0.05. Results. Atopic dermatitis had a small effect on the quality of life in 25.4 % patients, a moderate effect — in 40.8 %, a very large effect — in 19.7 %, and in 12.7 % of patients, atopic dermatitis caused an extremely large effect on the quality of life. Spearman’s correlation coefficient of severity indicators on the SCORAD and the CDLQI was Ro = 0.932; a correlation was found at the significance level of p < 0.01. When evaluating correlation indicators in subgroups of children by degree of severity, a difference was found: in patients with mild atopic dermatitis, there was no correlation (Ro = 0, p > 0.05), in contrast to the group with moderate to severe (Ro = 0.625, p < 0.01) and severe atopic dermatitis (Ro = 0.688, p = 0.01). The quality of life indicator had a positive correlation with the age of patients and duration of the disease, which may be related to a more severe course and a greater social and psychological burden for older children. Conclusions. The Ukrainian version of CDLQI is a reliable tool for assessing the quality of life of paediatric patients with atopic dermatitis.

Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study.

Atopic dermatitis (AD) is a heterogeneous disease, with involvement of the T-helper cell (Th) 2, Th22, and potentially Th17 pathways, supporting the use of interleukin (IL)-23 and IL-22 blockade in AD. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial (NCT03706040) evaluated the efficacy and safety of risankizumab, an IL-23 inhibitor, in patients (≥ 12years old) with moderate-to-severe AD, defined by an Eczema Area and Severity Index (EASI) ≥ 16, affected body surface area ≥ 10%, and a Validated Investigator Global Assessment for AD (vIGA-AD) score ≥ 3. Patients were randomized 2:2:1 to 16-week treatment with risankizumab 150mg, risankizumab 300mg, or placebo in period A; patients receiving placebo were re-randomized 1:1 to risankizumab 150mg or 300mg and patients receiving risankizumab continued on their randomized dose in 36-week period B. Study drug was administered at baseline and weeks 4, 16, 28, and 40. The primary endpoint was the proportion of patients achieving a ≥ 75% reduction from baseline in EASI (EASI 75) at week 16. Safety was analyzed in all randomized patients who received study medication. Neither the risankizumab 150mg (n = 69) nor the 300mg dose group (n = 69) demonstrated a significantly higher proportion of patients achieving EASI 75 at week 16 compared with the placebo group (n = 34; treatment difference [95% CI] 13.0% [-1.7 to 27.7%; P = 0.084] and 10.0% [-4.6 to 24.6%; P = 0.179], respectively). Most adverse events were mild to moderate in severity; five patients receiving risankizumab reported serious adverse events, including two patients who reported cellulitis. Risankizumab was generally well tolerated, with no new safety concerns identified. The study's primary endpoint was not met, with no significant difference in the proportion of patients achieving an EASI 75 response at week 16 with risankizumab 150mg or 300mg versus placebo. ClinicalTrials.gov NCT03706040.

The Efficacy of Moisturisers Containing Ceramide Compared with Other Moisturisers in the Management of Atopic Dermatitis: A Systematic Literature Review and Meta-Analysis.

Atopic dermatitis (AD), also known as atopic eczema, is a chronic inflammatory skin condition that recurs frequently and has diverse clinical features. The main mechanism of AD is the dysfunction of the skin-epidermal barrier. One of the causes of stratum corneum (SC) structural integrity disruption is the decreased production of ceramide, an important lipid component in SC. The latest generation of moisturisers contain ceramide to help replace this lipid deficit. This study aimed to compare the efficacy of moisturisers containing ceramide with other moisturisers for AD management. Searches were conducted systematically on PubMed, the Cochrane Library, ScienceDirect, Clinicaltrials.gov, and Google Scholar for studies published from January 2012 to July 2022. Interventions and outcomes were compared in this study. Statistical analysis was performed with ReviewManager 5.4 software. Five articles met the eligibility and inclusion criteria. Three articles were meta-analyses on trans-epidermal water loss (TEWL) outcomes and two articles were meta-analyses on SCORing Atopic Dermatitis (SCORAD) outcomes. A meta-analysis of TEWL results found that TEWL values were not significantly different in subjects treated with ceramide-containing moisturisers (mean difference: -3.56, 95% CI [-8.63, 1.52], P = 0.17) with high heterogeneity (I2 = 92%) compared to other treatments. The change in SCORAD was significantly higher in moisturisers containing ceramide (mean difference: -0.98, 95% CI [-1.63, -0.33], P = 0.003) with low heterogeneity (I2 = 0%). Moisturisers containing ceramide improve SCORAD and TEWL; however only the changes in SCORAD in moisturisers containing ceramide is superior to other moisturisers.

The risk factors for food allergy in infants with atopic dermatitis.

There is a lack of information about which risk factors accompany food allergy (FA) in infants with atopic dermatitis (AD). We hypothesized that we would be able to predict FA through risk factors in infants with AD. This prospective descriptive cross-sectional study was performed with infants aged 1-12 months with newly diagnosed AD. The SCORing Atopic Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI), Infants` Dermatitis Quality Of Life (IDQOL), and Family Dermatological Life Quality (FDLQ) index scores were calculated at first admission. We developed a new tool, Sites of Eczema (SoE), to score sites of eczema on the body. A total of 279 infants with AD were included. FA was found in 166 (59.5%) infants with AD, of whom 112 had single and 54 had multiple FAs. The SCORAD index, EASI scores, IDQOL1, IDQOL2, and FDQL, and SoE scores were higher in the subgroup with FA compared to that without FA (p < 0.001). In the multivariate regression model, eosinophil count (odds ratio [OR]=1.00, 95% confidence interval: [CI, 1.00-1.00]; p=0.008), serum total IgE level (OR=1.02, 95% CI: [1.00-1.03]; p=0.002), pruritus score (OR=0.87, 95% CI: [0.77-0.97]; p=0.019), SCORAD index (OR=1.04, 95% CI: [1.01-1.08]; p=0.008), FDQL index (OR=1.09, 95% CI: [1.01-1.18]; p=0.014), and SoE score (OR=1.48, 95% CI: [1.00-2.19]; p=0.046) were identified as the highest risk factors for FA in infants with AD. Serum total IgE levels, eosinophil counts and ratio, SCORAD index and EASI scores, IDQOL and FDLQ index, pruritus and sleep disturbance scores, and SoE scores were identified as risk factors for FA in infants with AD in this study. The SoE score is an important risk factor for FA in infants with AD. We recommend that the risk factors for FA in patients with AD guide the management of these patients.

Strategies for coping with stress in mothers of children with atopic dermatitis - a cross-sectional study.

Our previous study showed that the severity of atopic dermatitis (AD) in children significantly correlates with the quality of life and perceived stress in their mothers. To compare strategies for coping with stress in mothers of children with and without AD, as well as to investigate the relationship between coping strategies of mothers of affected children and AD variables, stress intensity, and quality of life. The study included 88 mothers of children with AD and 57 mothers of children without AD as controls. The severity of skin lesions in children with AD was assessed by the Scoring Atopic Dermatitis (SCORAD) index, and skin itch was evaluated by the Numerical Rating Scale (NRS). All mothers completed the sociodemographic questionnaire (SD), the Perceived Stress Scale (PSS), and the Coping Orientations to Problems Experienced (COPE) scale. Additionally, mothers of children with AD filled out the Family Dermatology Life Quality Index (FDLQI). There were no statistically significant differences in coping strategies between the groups. However, there were significant correlations between the selected coping strategies and AD severity, perceived stress of mothers, and quality of life of the entire family of affected children. Although mothers of children with AD experience higher levels of stress compared with mothers of children without AD, the disease does not change coping strategies. Psychological support for mothers of children with AD should be oriented toward strengthening cognitive coping strategies.

Obsessive compulsive symptoms in mothers of children with atopic dermatitis.

Maternal stress, depression and anxiety are associated with atopic dermatitis (AD) in offspring. However, the relationship between maternal obsessive compulsive symptoms (OCS) and AD in their children is unclear. To investigate whether maternal OCS are associated with AD in offspring. A total of 75 children with AD diagnosed by the paediatric allergist and 76 healthy children and their mothers were included in the study. A Turkish version of the Maudsley Obsessive Compulsive Inventory (MOCI-T) was used to assess OCS of mothers in both groups. Total MOCI-T score and slowness, doubt, and rumination subscale scores were higher in the AD group than in the healthy group (p = 0.007, p = 0.001, p = 0.012 and p = 0.011, respectively) but washing/cleaning and checking subscale scores did not reach a statistically significant difference (p = 0.203 and p = 0.053, respectively). There was no correlation between SCORing Atopic Dermatitis (SCORAD) and MOCI-T/subscales scores. Our study provides evidence for associations between maternal OCS and infantile AD. The findings support recommendations for psychosocial support of mothers of children with AD.

Therapeutic effectiveness of probiotics for atopic dermatitis: A systematic review and meta-analysis of randomized controlled trials with subgroup analysis.

The effect of probiotics in the treatment of atopic dermatitis (AD) is inconclusive, partially due to the heterogeneities of AD. The aim of the present study was to investigate the efficacy of probiotics in the treatment of AD with a subgroup analysis according to country, severity of AD, duration of supplementation, and probiotic strain. Original articles reporting the therapeutic efficacy of probiotics for AD were identified by searching PubMed, Cochrane Library databases, and Embase from inception to September 30, 2022. This meta-analysis included 1,382 patients with AD from 25 randomized controlled trials. Probiotic supplementation was effective for the treatment of AD, reflected in a significant decrease in the SCORing Atopic Dermatitis (SCORAD) index (SMD, -4.0; 95%CI, -7.3 to -0.7). The subgroup analysis showed a significant therapeutic effect for AD among patients with mild or moderate AD (SMD, -1.4; 95%CIs -2.2 to -0.7), in those supplemented for more than three months (SMD, -5.1; 95%CIs -9.7 to -0.4), and in those supplemented with a probiotic that contained Lactobacillus spp. strains combined with or without other strains (SMD, -4.4; 95%CIs -8.0 to -0.8). In addition, the therapeutic effects of probiotics showed differences according to country and geographic region. Probiotics can be beneficial for the treatment of AD, and their therapeutic effect may be individually tailored to improve it based on the severity of AD, strain of probiotics, duration of supplementation, and geographic region.

The long-term efficacy of heliotherapy in ameliorating disease severity and improving the quality of life in patients with atopic dermatitis.

Atopic dermatitis is one of the most common chronic inflammatory skin diseases adversely affecting the quality of life of both patients and their families. Heliotherapy, a treatment modality with high anti-inflammatory effects, is unjustifiably neglected in a country that has plenty of sunshine days throughout the year, but does not own the Cabinet for artificial phototherapy. To evaluate the power of individual heliotherapy in ameliorating disease severity and improving the quality of life, as well as to compare the results with those obtained from the studies evaluating group heliotherapies. We assessed disease severity and quality of life at three times: before commencing heliotherapy (Time 1), immediately after heliotherapy (Time 2), and 3 months after heliotherapy (Time 3). The tools we used are authorized scoring systems and questionnaires: SCORing Atopic Dermatitis (SCORAD), Eczema Area and Severity Index (EASI), Dermatology Life Quality Index (DLQI) and Severity of Pruritus Scale (SPS). A total of 24 patients were analysed in this observational study. Good clinical results were observed with a statistically significant decrease in SCORAD index by 40% and 31.1% at Time 2 and Time 3, respectively (p < 0.001). Improvement in the quality of life was statistically significant showing a decrease in DLQI score by 31.57% 3 months after heliotherapy, comparing to baseline values (p < 0.001). Our results revealed that 2-week heliotherapy has shown satisfying, long-lasting effects in clearing the skin changes, reducing and ameliorating pruritus intensity, as well as improving the quality of life.

Evaluating the Effect of Eicosapentaenoic Acid in Children With Atopic Dermatitis: A Randomized Triple-Blind Clinical Trial.

To evaluate the effects of dietary eicosapentaenoic acid (EPA) in children with atopic dermatitis. Forty-eight children with atopic dermatitis were randomly allocated to receive either 250 mg twice daily EPA (n = 24) or placebo (n = 24) for 4 weeks. The absolute improvement in the SCORing Atopic Dermatitis (SCORAD) index and the necessity to use topical corticosteroids was evaluated. Based on an intention-to-treat analysis, after 2 weeks the scores decreased to 30.50 ± 8.91 and 38.34 ± 10.52 in the EPA and placebo groups, respectively (p = 0.015). Per-protocol analysis showed a decrease in scores to 18.01 ± 10.63 in the EPA group and to 30.11 ± 9.58 in the placebo group (p = 0.001). After 2 weeks, corticosteroid was needed in 11 (50.0%) patients in the EPA group and 14 (58.3%) patients in the placebo group (p = 0.571), and after 4 weeks, it was needed in 7 (33.3%) patients in the EPA group and 14 (63.6%) patients in the placebo group, respectively (p = 0.047). Our results show significant favorable effects of EPA on the SCORAD scale and with regard to the necessity for corticosteroid readministration. Few adverse effects were reported in the 2 groups. We conclude that EPA supplementation is a well-tolerated and effective add-on strategy for reducing the severity of atopic dermatitis in children.

Burden, Control, and Treatment of Moderate to Severe Atopic Dermatitis in 2021: A United States Patient Survey Study.

Recent data on unmet needs in the treatment of moderate to severe atopic dermatitis (AD) in the US are not available. To describe disease control, quality of life (QoL), and treatment satisfaction in a United States population with moderate-to-severe AD. Cross-sectional 2021 survey conducted among US patients recruited to an online survey from Kantar e-profiles, their panel partners, and Global Perspectives. Adults with self-reported, physician-diagnosed AD completed the primary survey. Of those reporting moderate to severe AD, a subset, including patients who &ldquo;strongly disagreed,&rdquo; &ldquo;somewhat disagreed,&rdquo; or were &ldquo;neutral&rdquo; on the statement &ldquo;my eczema is adequately controlled&rdquo; (&ldquo;inadequately controlled&rdquo;) with varying experience with approved biologic treatment (dupilumab), completed a second, enriched survey. Outcome measures evaluated included self-reported disease control and severity and validated measures including Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD), Dermatology Life Quality Index (DLQI), Recap of Atopic Eczema (RECAP), and Treatment Satisfaction Questionnaire for Medication (TSQM-9). Of 3,285 patients who participated in the primary survey, 1,935 self-reported moderate-to-severe AD, 979 (51%) of whom reported inadequate control. A total of 371 completed the enriched survey, leading to an analytic sample with 87 controlled patients and 284 inadequately controlled patients (178/284 inadequately controlled patients never received dupilumab, 23 previously received it, and 83 were currently receiving it). Mean RECAP, PO-SCORAD, and DLQI scores were significantly worse (P&lt;0.01) for inadequately controlled vs controlled patients: 7.26 vs 13.9; 38.3 vs 26.9; and 9.9 vs 7.0, respectively. Mean TSQM-9 scores for inadequately controlled vs controlled patients were significantly worse across all domains&mdash;effectiveness, convenience, and global satisfaction (P&lt;0.01): 45.5 vs 69.5, 62.3 vs 72.5, 48.3 vs 69.3, respectively. This study found about half of the patients had inadequate control of their disease. This may partially be due to underuse of systemic biologics in eligible patients. There remains an unmet need for additional education on current and new systemic biologics that could allow patients to achieve better AD control, improved QoL, and greater overall treatment satisfaction. J Drugs Dermatol. 2023;22(2):119-131. doi:10.36849/JDD.7071.

Dupilumab Improves Clinical Scores in Pediatric Patients Aged 2 to &lt;18 Years with Uncontrolled Atopic Dermatitis: A Single‐Center, Real‐World Study

Dupilumab is the first biologic agent approved for treatment of moderate to severe atopic dermatitis (AD). Phase 3 clinical trials have shown the efficacy and safety in AD children. However, real‐world evidence is still scarce. Thirty‐nine pediatric patients with uncontrolled AD who regularly received dupilumab were included in a single‐center retrospective study. Eight patients (20.5%) were aged 2 to &lt;6 years, fifteen (38.5%) were 6 to &lt;12 years, and sixteen were 12 to &lt;18 years. Changes in clinical AD scores (EASI, SCORAD, P‐NRS, CDLQI, and POEM) at baseline, week 4 (W4), W10, and W16, as well as safety data were collected. At W16, the average EASI values dropped from 29.0 ± 16.2 to 5.1 ± 4.7, and 22 patients (73.3%) achieved 75% improvement in EASI. 16 patients (53.3%) achieved 75% improvement in SCORAD. Significant reduction was also observed in the changes of P‐NRS, CDLQI, and POEM values. Notably, the change of clinical scores was similar among three age subgroups. At W16, the mean percent decreases in EASI for 2 to &lt;6 years, 6 to &lt;12 years, and 12 to &lt;18 years, and subgroups were 67.3%, 78.5%, and 83.9%, respectively. A total of three cases of adverse effects were recorded, with conjunctivitis seen in two &gt;6‐year‐old patients and the injection site reaction in one &lt;6‐year‐old child. Dupilumab exhibited favorable efficacy and safety profile, including the 2 to &lt;6 years old subgroup.

The association of rs4696480 polymorphism in TLR2 gene and Staphylococcus aureus skin colonization in children with atopic dermatitis

Topicality. Up to 90% of patients with atopic dermatitis are colonized with S. aureus, with S. aureus predominance being unique to atopic dermatitis. TLR2 play a role in the presentation of S. aureus antigens in a course of atopic dermatits. Purpose - to investigate the association of rs4696480 polymorphism in TLR2 gene and S. aureus skin colonization. Materials and methods. The study included 101 patients with eczema and 84 healthy children. Skin swab cultures were taken. Subjects were classified as carriers if the cultures were positive, while those with culture found to be negative were classified as non-carriers. Genotyping for TLR2 rs4696480 was performed by using Real-time PCR. Results. We determined the prevalence of S. aureus carriage in a cohort study of atopic dermatitis patients in Ukraine. Skin culture for the presence of S. aureus was performed in 82 patients: 45.1% children had positive culture for S. aureus, 54.9% had a negative result. SCORing Atopic Dermatitis (SCORAD) index was significantly higher in S. aureus carriers (p&lt;0.001). There was no difference in genotype distribution among patients and control group (OR=1.021 (95% CI 0.507-2.054) for AT genotype, OR=0.880 (95% CI 0.398-1.947) for TT genotype, р&gt;0.05). AA genotype was significantly more frequent among S. aureus carriers (OR=2.745 (95% CI 0.865-8.708) for AT genotype, OR=7.000 (95% CI 1.852-26.462) for TT genotype. To our knowledge, the association of T16934A (rs4696480) and S. aureus colonization of lesion skin in children with atopic dermatitis have not been studied before. Conclusions. AA variant of TLR2 rs4696480 polymorphism predisposes to S. aureus colonization of skin in children with atopic dermatits. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the author.

Epidemiology of eczema in South-Eastern Australia.

Eczema is a common chronic debilitating skin condition in childhood. Data on the epidemiology and natural history of eczema across the life course are lacking. This analysis aimed to describe these epidemiological features in Australian children and adults. Data collected on eczema from four Australian cohort studies were analysed: namely HealthNuts, Melbourne Atopic Cohort Study (MACS), Tasmanian Longitudinal Health Study (TAHS) and the Australian arm of the European Community Respiratory Health Survey (ECRHS). Among children aged under 6 years, 28.8%-35.6% have ever-had eczema, and 16.7%-26.6% had 'current eczema'. Among those aged 6-12 years, 14.6%-24.7% had 'current eczema' with 12.0%-18.5% of those at ages of 6 and 10 years classified as having moderate-to-severe eczema according to the Scoring of Atopic Dermatitis (SCORAD) index. In adults, the prevalence of 'eczema ever' ranged between 13.8% and 48.4%. The 12-month period prevalence of eczema was 15.1% at age 18, while current eczema was 8.5% at an average age of 51, and 8.8% at an average age 53 years. Eczema was more common among young boys, but this difference became non-significant for older children and early adolescents. In contrast, eczema was more common for adult women than men. Eczema is common both in children and adults. The proportion of severe eczema in children was substantial.

An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study

OX40 is crucial for T-cell differentiation and memory induction. The anti-OX40 antibody, rocatinlimab inhibits the OX40 pathway. We evaluated the efficacy and safety of rocatinlimab in adults with moderate-to-severe atopic dermatitis. This multicentre, double-blind, placebo-controlled phase 2b study was done at 65 secondary and tertiary sites in the USA, Canada, Japan, and Germany. Eligible patients were adults (aged 18 years or older) with confirmed atopic dermatitis (American Academy of Dermatology Consensus Criteria or local diagnostic criteria) with moderate-to-severe disease activity, as defined by an Eczema Area and Severity Index (EASI) score of 16 or more, validated Investigator's Global Assessment for Atopic Dermatitis score of 3 (moderate) or 4 (severe), and affected body surface area 10% or higher at both screening and baseline, with documented history (within 1 year) of inadequate response to topical medications or if topical treatments were medically inadvisable. Patients were randomly assigned (1:1:1:1:1) to receive subcutaneous rocatinlimab every 4 weeks (150 mg or 600 mg) or every 2 weeks (300 mg or 600 mg) or subcutaneous placebo up to week 18, with an 18-week active-treatment extension and 20-week follow-up. Percentage change from baseline in EASI score was assessed as the primary endpoint at week 16 and during the active extension and follow-up in all randomly assigned patients exposed to study drug with a post-baseline EASI score at week 16 or earlier according to the group they were randomly assigned to. Safety was assessed in all randomly assigned patients exposed to study drug; patients were analysed according to the group they were randomly assigned to. The study is registered with ClinicalTrials.gov, NCT03703102. Between Oct 22, 2018, and Oct 21, 2019, 274 patients (114 [42%] women, 160 [58%] men; mean age 38·0 years [SD 14·5]) were randomly assigned to one of the rocatinlimab groups (217 [79%] patients) or to the placebo group (57 [21%] patients). Compared with placebo (-15·0 [95% CI -28·6 to -1·4]), significant least-squares mean percent reductions in EASI score at week 16 were observed in all rocatinlimab groups (rocatinlimab 150 mg every 4 weeks -48·3 [-62·2 to -34·0], p=0·0003; rocatinlimab 600 mg every 4 weeks -49·7 [-64·3 to -35·2], p=0·0002; rocatinlimab 300 mg every 2 weeks -61·1 [-75·2 to -47·0], p<0·0001; and rocatinlimab 600 mg every 2 weeks -57·4 [-71·3 to -43·4], p<0·0001). The most common adverse events during the double-blind period in patients receiving rocatinlimab (adverse events ≥5% of patients in the total rocatinlimab group and more common than the placebo group) were pyrexia (36 [17%] patients), nasopharyngitis (30 [14%] patients), chills (24 [11%] patients), headache (19 [9%] patients), aphthous ulcer (15 [7%] patients), and nausea (13 [6%] patients). There were no deaths. Patients treated with rocatinlimab had progressive improvements in atopic dermatitis, which was maintained in most patients after treatment discontinuation. Treatment was well tolerated. Kyowa Kirin.

Serum Levels of Eosinophil-Derived Neurotoxin, Platelet-Activating Factor and Vascular Endothelial Growth Factor in Adult Patients with Atopic Dermatitis-A Pilot Study.

Atopic dermatitis (AD) is a chronic, highly pruritic, relapsing-remitting inflammatory skin disease. The etiology of AD has not been fully explained yet and complex interactions of various small molecules are still being taken into account. The aim of this research was to investigate the serum eosinophil-derived neurotoxin (EDN), platelet activating factor (PAF) and vascular endothelial growth factor (VEGF) concentrations in relation to the disease severity and pruritus intensity in adult patients with AD. This pilot study was performed on 30 participants (15 patients with AD and 15 healthy controls). Blood samples were taken to examine the serum levels of EDN, PAF and VEGF using the enzyme-linked immunosorbent assay (ELISA) test. The severity of disease was assessed by the Scoring Atopic Dermatitis (SCORAD) index. The intensity of pruritus, as a subjective symptom, was determined by the Visual Analogue Scale (VAS). Obtained results revealed that the EDN (p = 0.016) and VEGF (p = 0.032), but not PAF (p = 0.841) concentrations were significantly higher in patients with AD compared with those of the control group. There was positive correlation between the EDN level and the SCORAD index in patients with AD (r = -0.9, p = 0.037) which was not found for the PAF and VEGF levels. Circulating EDN, PAF and VEGF levels were not significantly correlated with the severity of pruritus. Our results suggest that the END and VEGF serum levels are significantly increased in patients with AD compared to control group. Moreover, EDN might be useful to reflect the severity of symptoms.

Hypnotherapy, Intermittent Fasting, and Exercise Group Programs in Atopic Dermatitis: A Randomized Controlled Explorative Clinical Trial During the COVID-19 Pandemic.

Background: Patients with atopic dermatitis (AD) frequently use healthy lifestyle behaviors, although their benefits are unclear. This study's aim was to investigate the effectiveness of hypnotherapy, fasting with diet adjustments, and exercise in AD patients. Methods: In a four-armed randomized controlled monocenter open explorative clinical trial, adult patients with mild-to-moderate severe AD underwent, over 16 weeks, a five-session hypnotherapy group program (HTP), a five-session intermittent fasting with diet adjustment group program (IFDP), a five-session exercise group program (EP), or no study intervention (control) as add-on to topical corticosteroid use if required. Endpoints included subjectively perceived itching on a visual analogue scale (VAS, 0-100 mm); disease severity by SCORing Atopic Dermatitis (SCORAD); and adverse events (AEs). Endpoints were analyzed descriptively in the Full Analysis Set (FAS). Due to the coronavirus disease 2019 (COVID-19) pandemic, relevant changes to the study protocol included online in addition to "in-presence" group interventions, closing the study arm EP and premature trial termination before randomization of 120 intended patients. Results: During the COVID-19 pandemic, study recruitment was poor. The FAS included 20 patients (17 female) with 35.0 ± 12.1 (mean ± standard deviation [SD]) years of age. At baseline, mean ± SD for HTP (n = 6), IFDP (n = 4), EP (n = 1), and control (n = 9) were VAS itching 63.2 ± 18.0, 65.0 ± 13.9, 43.0 mm, 62.1 ± 17.3; SCORAD 43.0 ± 13.6, 47.0 ± 21.0, 60.3, 39.1 ± 15.6. After 16 weeks, endpoints were VAS itching 26.0 ± 16.4, 31.7 ± 9.9, 23.0 mm, 39.3 ± 27.0; SCORAD 24.1 ± 12.2, 29.1 ± 19.1, 49.1, 25.5 ± 14.4. No serious AEs related to the interventions were observed. Conclusion: Despite very small groups, study results indicated potential beneficial changes to baseline in perceived itching intensity, disease severity, and disease-specific quality of life for HTP and IFDP. Therefore, further clinical trials should be performed investigating the effectiveness and safety of all interventions. Clinical Trial Registration: January 31, 2020 German Clinical Trials Register (DRKS): DRKS00020557, Universal Trial Number (UTN): U1111-1247-1512.

Sensitivity to treatment and score bands of the Infants and Toddlers Dermatology Quality of Life questionnaire

The Infants and Toddlers Dermatology Quality of Life (InToDermQoL) questionnaire is the first dermatology-specific proxy health related QoL instrument for children from birth to 4years. Score meaning bands and the sensitivity to successful therapeutic intervention are important to interpret the clinical meaning of an instrument. The aim of the present study was to check the sensitivity to successful therapeutic intervention and establish score bands of the InToDermQoL questionnaire. Parents or grandparents of 424 children with skin diseases from Spain, Malta, Croatia, Romania, Greece, and Ukraine filled in national language versions of the InToDermQoL questionnaire. Disease severity of children with atopic dermatitis was assessed by SCORAD (Scoring atopic dermatitis). Cohen's d was used to assess the responsiveness of the instrument. The mean total InToDermQoL scores significantly decreased after treatment. Severity grading of the SCORAD scores gave stratification of the InToDermQoL severity grades based on 95% confidence intervals. Scores below a calculated minimal important difference of 2 corresponded to no effect on patient's health related QoL. Score banding may be slightly different across patient population and study context. All 3 age-specific versions of the InToDermQoL questionnaire showed sensitivity to treatment. Score bands for the InToDermQoL questionnaire have been established.