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Background: Little is known about the burden of atopic dermatitis (AD) encountered in US primary care practices and the frequency and type of skin care practices routinely used in children. Objective: To estimate the prevalence of AD in children 0 to 5 years attending primary care practices in the United States and to describe routine skin care practices used in this population. Design: A cross-sectional survey study of a convenience sample of children under the age of 5 attending primary care practices for any reason. Setting: Ten primary care practices in 5 US states. Results: Among 652 children attending primary care practices, the estimated prevalence of ever having AD was 24% (95% CI, 21–28) ranging from 15% among those under the age of 1 to 38% among those aged 4 to 5 years. The prevalence of comorbid asthma was higher among AD participants compared to those with no AD, namely, 12% and 4%, respectively (P Conclusions: Our study found a large burden of AD in the primary care practice setting in the US. The majority of households reported skin care practices that may be detrimental to the skin barrier, such as frequent bathing and the routine use of moisturizers with high water: oil ratios. Clinical trials are needed to identify which skin care practices are optimal for reducing the significant burden of AD in the community.

BACKGROUND: While numerous genetic loci associated with atopic dermatitis (AD) have been discovered, to date, work leveraging the combined burden of AD risk variants across the genome to predict disease risk has been limited. OBJECTIVES: This study aims to determine whether polygenic risk scores (PRSs) relying on genetic determinants for AD provide useful predictions for disease occurrence and severity. It also explicitly tests the value of including genome-wide association studies of related allergic phenotypes and known FLG loss-of-function (LOF) variants. METHODS: AD PRSs were constructed for 1619 European American individuals from the Atopic Dermatitis Research Network using an AD training dataset and an atopic training dataset including AD, childhood onset asthma, and general allergy. Additionally, whole genome sequencing data were used to explore genetic scoring specific to FLG LOF mutations. RESULTS: Genetic scores derived from the AD-only genome-wide association studies were predictive of AD cases (PRS(AD): odds ratio [OR], 1.70; 95% CI, 1.49–1.93). Accuracy was first improved when PRSs were built off the larger atopy genome-wide association studies (PRS(AD+): OR, 2.16; 95% CI, 1.89–2.47) and further improved when including FLG LOF mutations (PRS(AD++): OR, 3.23; 95% CI, 2.57–4.07). Importantly, while all 3 PRSs correlated with AD severity, the best prediction was from PRS(AD++), which distinguished individuals with severe AD from control subjects with OR of 3.86 (95% CI, 2.77–5.36). CONCLUSIONS: This study demonstrates how PRSs for AD that include genetic determinants across atopic phenotypes and FLG LOF variants may be a promising tool for identifying individuals at high risk for developing disease and specifically severe disease.

Atopic dermatitis is a common inflammatory skin disease. New understanding in disease pathogenesis has led to a considerable number of promising new drugs in development. New topical agents can be especially helpful for children, providing an alternative to the need for chronic topical corticosteroid use. While many patients with mild or moderate disease can be managed with topical treatments, there are unmet needs for recalcitrant and severe cases. New and developing therapies hold promise for real advances in management of this complex disease.

Background/Objectives: There is a paucity of validated tools for diagnosing atopic dermatitis (AD) in very young children that do not rely on clinical evaluation. The Childhood Eczema Questionnaire (CEQ)-a diagnostic tool for AD in children younger than 2 years that a caretaker can complete-was recently validated in Sweden. The objective of this study was to validate the tool in a U.S. population. As a substudy, we added an additional question that was independently assessed. Methods: Children younger than 2 years old were recruited from a dermatology clinic. Their caretakers completed a questionnaire containing the original tool's three questions as well as a fourth question that increased the time frame measured from 1 week to 6 months. Questionnaires with all "yes" answers were considered positive and were compared with a dermatologist diagnosis of AD. Results: A total of 283 subjects were recruited. The first three questions (the original CEQ) predicted a positive diagnosis of AD with a sensitivity of 0.72 (95% confidence interval [CI] 0.58, 0.82) and a specificity of 0.93 (95% CI 0.87, 0.95). In a separate analysis we included the first two questions and the fourth question and found that the sensitivity increased to 0.82 (95% CI 0.69, 0.90) with a specificity of 0.89 (95% CI 0.83, 0.93). Conclusion: This study validates a novel parental questionnaire for the diagnosis of AD in children younger than 2 years in a U.S. clinic population. (Less)

Interleukin-31 may play a role in the pathobiologic mechanism of atopic dermatitis and pruritus. We wanted to assess the efficacy and safety of nemolizumab (CIM331), a humanized antibody against interleukin-31 receptor A, in the treatment of atopic dermatitis.In this phase 2, randomized, double-blind, placebo-controlled, 12-week trial, we assigned adults with moderate-to-severe atopic dermatitis that was inadequately controlled by topical treatments to receive subcutaneous nemolizumab (at a dose of 0.1 mg, 0.5 mg, or 2.0 mg per kilogram of body weight) or placebo every 4 weeks or an exploratory dose of 2.0 mg of nemolizumab per kilogram every 8 weeks. The primary end point was the percentage improvement from baseline in the score on the pruritus visual-analogue scale (on which a negative change indicates improvement) at week 12. Secondary end points included changes in the score on the Eczema Area and Severity Index (EASI, on which a negative change indicates improvement), and body-surface area of atopic dermatitis.Of 264 patients who underwent randomization, 216 (82%) completed the study. At week 12, among the patients who received nemolizumab every 4 weeks, changes on the pruritus visual-analogue scale were -43.7% in the 0.1-mg group, -59.8% in the 0.5-mg group, and -63.1% in the 2.0-mg group, versus -20.9% in the placebo group (P0.01 for all comparisons). Changes on the EASI were -23.0%, -42.3%, and -40.9%, respectively, in the nemolizumab groups, versus -26.6% in the placebo group. Respective changes in body-surface area affected by atopic dermatitis were -7.5%, -20.0%, and -19.4% with nemolizumab, versus -15.7% with placebo. Among the patients receiving nemolizumab every 4 weeks, treatment discontinuations occurred in 9 of 53 patients (17%) in the 0.1-mg group, in 9 of 54 (17%) in the 0.5-mg group, and in 7 of 52 (13%) in the 2.0-mg group, versus in 9 of 53 (17%) in the placebo group.In this phase 2 trial, nemolizumab at all monthly doses significantly improved pruritus in patients with moderate-to-severe atopic dermatitis, which showed the efficacy of targeting interleukin-31 receptor A. The limited size and length of the trial preclude conclusions regarding adverse events. (Funded by Chugai Pharmaceutical; XCIMA ClinicalTrials.gov number, NCT01986933 .).

BackgroundAtopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods for capturing long-term control of AD.ObjectiveWe sought to identify how long-term control has been captured in published randomized controlled trials (RCTs). Results will initiate consensus discussions on how best to measure long-term control in the core outcome set for AD.MethodsWe conducted a systematic review of RCTs of AD treatments published between 2000 and 2013, with a follow-up period of 3 months or longer, at least 1 outcome measure recorded at 3 or more time points, full article available, and published in English.ResultsIn all, 101 of 353 RCTs were eligible. Methods to capture long-term control included: repeated measurement of AD outcomes (92 RCTs; 91%), use of AD medication (29 RCTs; 28.7%), and AD flares/remissions (26 RCTs; 25.7%). Repeated measurements of AD outcomes were typically collected 3 to 5 times during a trial, but analysis methods often failed to make best use of the data. Time to first flare was most commonly used for trials including flare data (21/52). Medication use was recorded based on quantity, potency, and frequency of application.LimitationsWe included RCT data only.ConclusionThis review illustrates the difficulties in measuring long-term control, and points to the need for improved harmonization of outcomes.

Background Peripheral leukocytes in patients with atopic dermatitis (AD) have elevated phosphodiesterase-4 activity, which is associated with production of proinflammatory mediators. OPA-15406 is a phosphodiesterase-4 inhibitor with high selectivity for phosphodiesterase-4-B. Objectives We sought to assess effectiveness and tolerability of topical OPA-15406 in patients with AD. Methods This was a randomized, double-blind, vehicle-controlled, phase-II study. Patients 10 to 70 years of age with mild or moderate AD received topical OPA-15406 0.3% (n = 41), OPA-15406 1% (n = 43), or vehicle (n = 37) twice daily for 8 weeks. Results The primary end point, Investigator Global Assessment of Disease Severity score of 0 or 1 with greater than or equal to 2-grade reduction, was met at week 4 in the OPA-15406 1% group ( P = .0165 vs vehicle). Mean percentage improvement from baseline Eczema Area and Severity Index score for OPA-15406 1% was notable in week 1 (31.4% vs 6.0% for vehicle; P = .0005), even larger in week 2 (39.0% vs 3.0%; P = .0001), and persisted for 8 weeks. Visual analog scale pruritus scores improved from moderate to mild within the first week in the OPA-15406 1% group (36.4% mean change; P = .0011). OPA-15406 levels in blood were negligible. Incidence of adverse events was low, with most events mild in intensity. Limitations Further confirmatory phase-III studies are required. Conclusion OPA-15406 ointment may provide an effective therapeutic modality for patients with mild to moderate AD.

Background Atopic dermatitis (AD) is often the first step in the atopic march leading to the development of asthma or allergic rhinitis. The goal of this study was to determine whether early intervention with pimecrolimus limits the atopic march in infants with AD and to evaluate its efficacy and safety. Methods This was a 3-year double-blind study in which patients were randomized to pimecrolimus or vehicle and then open-label pimecrolimus for a planned further 3 years. Rescue topical corticosteroid was permitted if 3 days of study medication led to no improvement; investigators made decisions on rescue medication until week 14 and caregivers thereafter. Efficacy assessments included disease-free days, Eczema Area and Severity Index, and body surface area affected. Results Infants ages 3 to 18 months with recent-onset AD (≤3 months) were observed for a mean of 2.8 years (N = 1,091). No significant differences between pimecrolimus- and placebo-treated groups were found in the percentage of patients with AD who developed asthma (10.7%) or other allergic conditions (allergic rhinitis, 22.4%; food allergy, 15.9%; allergic conjunctivitis, 14.1%; one or more atopic comorbidities, 37.0%) by study end. Allergic rhinitis, food allergy, and having one or more atopic comorbidities (but not asthma or allergic conjunctivitis alone) developed significantly more often in infants with greater AD severity at baseline. Pimecrolimus was significantly more effective than vehicle for AD treatment at week 14. Adverse event incidences were similar. Conclusions This longitudinal observation of infants with AD provides evidence of the atopic march. Pimecrolimus was safe and effective in infants with mild to moderate AD.

BACKGROUND Dust mites (DMs) play a role in type I respiratory allergy. Studies relating to DM irritant versus immune reactions are somewhat conflicting in atopic dermatitis (AD). OBJECTIVE The aim of this study was to assess the diagnostic use of patch testing to DM in patients with AD and other dermatitides. METHODS We performed a prospective study of 323 adults recruited in a patch testing clinic. Patch testing antigens were DM extract (0.01%, 0.1%, 1%, 10%, and 20% in petrolatum; Chemotechnique) and/or 200 index of reactivity in petrolatum (Stallergenes). Patches were placed and read at 48 hours with delayed readings after 72 to 168 hours. RESULTS There was no association of DM positivity with AD, asthma, hay fever, or demographic factors. There was no association of DM positivity with the clinical diagnosis or phenotype. The number of positive (+, ++, and +++) and doubtful reactions to Chemotechnique DM extract increased with higher concentrations. Positive reactions to DM had a morphological appearance characterized by numerous discrete erythematous papules and, rarely, papulovesicles. Positive reactions to Stallergenes DM 200 IR were infrequent and all weak reactions, similar to DM 0.01%. CONCLUSIONS Patch testing to DM does not seem to have clinical use for determining the etiology of dermatitis.

Atopic dermatitis (AD) is a highly prevalent, chronic inflammatory skin disease that affects children and adults. The pathophysiology of AD is complex and involves skin barrier and immune dysfunction. Many immune cytokine pathways are amplified in AD, including T helper (Th) 2, Th22, Th17 and Th1. Current treatment guidelines recommend topical medications as initial therapy; however, until recently, only two drug classes were available: topical corticosteroids (TCSs) and topical calcineurin inhibitors (TCIs). Several limitations are associated with these agents. TCSs can cause a wide range of adverse effects, including skin atrophy, telangiectasia, rosacea and acne. TCIs can cause burning and stinging, and the prescribing information lists a boxed warning for a theoretical risk of malignancy. Novel medications with new mechanisms of action are necessary to provide better long-term control of AD. Phosphodiesterase 4 (PDE4) regulates cyclic adenosine monophosphate in cells and has been shown to be involved in the pathophysiology of AD, making it an attractive therapeutic target. Several PDE4 inhibitors are in clinical development for use in the treatment of AD, including crisaborole, which recently became the first topical PDE4 inhibitor approved for treatment of mild to moderate AD. This review will further describe the pathophysiology of AD, explain the possible role of PDE4 in AD and review PDE4 inhibitors currently approved or being investigated for use in AD.

High-risk human papillomavirus (hrHPV) infection is more likely to persist and cause cervical cancer in immunosuppressed women. Atopic dermatitis, which is known to affect cell-mediated immunity and skin barrier function, is associated with recalcitrant warts; therefore, we hypothesized that women with atopic dermatitis may be more likely to be positive for hrHPV infection and progress to high-grade cervical dysplasia.A retrospective case-control study of 1,160 women who were either positive or negative for hrHPV in their index cervical cytology. Patient age, race, history of atopic dermatitis, allergic rhinitis, smoking, body mass index, socioeconomic status, marital status, hormone contraceptive use, and 2-year clinical outcomes (follow-up hrHPV testing and cervical biopsy results) were recorded. All cases with atopic dermatitis (n = 74) were confirmed by a dermatologist. Analyses were restricted to females with documented clinical follow-up, which yielded 577 hrHPV-positive and 583 hrHPV-negative cases for comparison. Associations were examined by t test, χ test, and multivariate logistic regression.Atopic dermatitis was more common in the hrHPV-positive cases (48/577, 8.3%) compared with HPV-negative controls (26/583, 4.5%, p = .007). Multivariate logistic regression analysis revealed an adjusted odds ratio of 3.75 (95% CI = 1.3-10.9, p = .02) after controlling for significant covariates, such as age and marital status. Smoking was not associated with hrHPV infection, persistence, or high-grade cervical dysplasia in these cases.Atopic dermatitis is associated with cervical hrHPV infection in adult women.

SummaryBackground The Eczema Area and Severity Index (EASI) is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis (AD). The EASI was identified as one of the best-validated outcome measures for AD; however, no previous studies address how to interpret the EASI score for clinical use. Objectives To evaluate the interpretability and the ease of use of the EASI. Methods A retrospective analysis of paediatric and adult patients with AD was performed. Interpretability was evaluated by stratifying the EASI scores according to the Investigator's Global Assessment. The severity strata displaying the highest kappa coefficient of agreement were then selected as the recommended EASI band. The time to administer the EASI was recorded in a subgroup of patients. Results The suggested severity strata for the EASI are as follows: 0 = clear; 0·1–1·0 = almost clear; 1·1–7·0 = mild; 7·1–21·0 = moderate; 21·1–50·0 = severe; 50·1–72·0 = very severe (κ = 0·75). The EASI was also found to be acceptable in terms of ease of use, with assessments by trained investigators taking approximately 6 min. Conclusions Our study provides the first guide for interpreting the EASI score. It enables translation of the EASI numerical output into an AD global severity state that should be more meaningful to providers and patients. Along with a short administration time, the EASI demonstrates adequate feasibility, further supporting its use in clinical trials.

Background Nemolizumab, an anti–IL-31 receptor A mAb, improved pruritus, dermatitis, and sleep in adults with moderate-to-severe atopic dermatitis that was inadequately controlled by topical treatments in a phase II, 12-week, randomized, double-blind, placebo-controlled study (part A; NCT01986933 ). Objective We sought to assess the long-term efficacy and safety of nemolizumab injected subcutaneously every 4 weeks (Q4W) or every 8 weeks (Q8W) in a 52-week, double-blind extension (part B). Methods During part B, patients continued the previous nemolizumab dose (0.1, 0.5, or 2.0 mg/kg Q4W or 2.0 mg/kg Q8W). Part B end points included percentage improvement from baseline in pruritus visual analog scale and dermatitis scores (including the Eczema Area and Severity Index). Results Overall, 216 of 264 patients completed part A, and 191 entered part B; 131 completed part B. In 153 patients randomized to nemolizumab in part A, improvement from baseline in pruritus visual analog scale score was maintained/increased from weeks 12 to 64, with greatest improvement in the 0.5-mg/kg Q4W group (percentage change from baseline at week 64: −73.0, −89.6, −74.7, and −79.1 in the 0.1-, 0.5-, and 2.0-mg/kg Q4W and 2.0-mg/kg Q8W groups, respectively). Improvement from baseline in dermatitis scores was also maintained/increased to week 64 (percentage change in Eczema Area and Severity Index score: −68.5, −75.8, −78.9, and −69.3 in the 0.1-, 0.5-, and 2.0-mg/kg Q4W and 2.0-mg/kg Q8W groups, respectively). Over 64 weeks, 83% to 89% had 1 or more adverse events, with no new safety concerns identified. Conclusion Nemolizumab for up to 64 weeks was efficacious and overall well tolerated in patients with moderate-to-severe atopic dermatitis inadequately controlled by topical therapy.

Patients with atopic dermatitis (AD) are commonly colonized with Staphylococcus aureus (AD S. aureus + ), but what differentiates this group from noncolonized AD patients (AD S. aureus – ) has not been well studied. To evaluate whether these two groups have unique phenotypic or endotypic features, we performed a multicenter, cross-sectional study enrolling AD S. aureus + (n = 51) and AD S. aureus – (n = 45) participants defined by the presence or absence of S. aureus by routine culture techniques and nonatopic, noncolonized control individuals (NA S. aureus – ) (n = 46). Filaggrin ( FLG ) genotypes were determined, and disease severity (Eczema Area and Severity Index, Rajka-Langeland Severity Score, Investigator's Global Assessment score, Numerical Rating Scale, and Dermatology Life Quality Index) was captured. Skin physiology was assessed (transepidermal water loss [TEWL], stratum corneum integrity, hydration, and pH), and serum biomarkers were also measured. We found that AD S. aureus + patients had more severe disease based on all scoring systems except itch (Numerical Rating Scale), and they had higher levels of type 2 biomarkers (eosinophil count, tIgE, CCL17, and periostin). Additionally, AD S. aureus + patients had significantly greater allergen sensitization (Phadiatop and tIgE), barrier dysfunction (TEWL and stratum corneum integrity), and serum lactate dehydrogenase (LDH) than both the AD S. aureus – and NA S. aureus – groups. FLG mutations did not associate with S. aureus + colonization. In conclusion, adult patients with AD who are colonized on their skin with S. aureus have more severe disease, greater type 2 immune deviation, allergen sensitization, barrier disruption, and LDH level elevation than noncolonized patients with AD.

Atopic dermatitis is a common, chronic inflammatory dermatosis that can affect all age groups. This evidence-based guideline addresses important clinical questions that arise in its management. In this final section, treatments for flare prevention and adjunctive and complementary therapies and approaches are reviewed. Suggestions on use are given based on available evidence.

Background Atopic dermatitis (atopic eczema) is a chronic inflammatory skin disease that has reached epidemic proportions in children worldwide and is increasing in prevalence. Because of the significant socioeconomic effect of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on disease prevention, with limited success. Recent advances in cutaneous biology suggest skin barrier defects might be key initiators of atopic dermatitis and possibly allergic sensitization. Objective Our objective was to test whether skin barrier enhancement from birth represents a feasible strategy for reducing the incidence of atopic dermatitis in high-risk neonates. Methods We performed a randomized controlled trial in the United States and United Kingdom of 124 neonates at high risk for atopic dermatitis. Parents in the intervention arm were instructed to apply full-body emollient therapy at least once per day starting within 3 weeks of birth. Parents in the control arm were asked to use no emollients. The primary feasibility outcome was the percentage of families willing to be randomized. The primary clinical outcome was the cumulative incidence of atopic dermatitis at 6 months, as assessed by a trained investigator. Results Forty-two percent of eligible families agreed to be randomized into the trial. All participating families in the intervention arm found the intervention acceptable. A statistically significant protective effect was found with the use of daily emollient on the cumulative incidence of atopic dermatitis with a relative risk reduction of 50% (relative risk, 0.50; 95% CI, 0.28-0.9; P = .017). There were no emollient-related adverse events and no differences in adverse events between groups. Conclusion The results of this trial demonstrate that emollient therapy from birth represents a feasible, safe, and effective approach for atopic dermatitis prevention. If confirmed in larger trials, emollient therapy from birth would be a simple and low-cost intervention that could reduce the global burden of allergic diseases.

Streszczenie Wprowadzenie Atopowe zapalenie skory (wyprysk atopowy) jest przewleklą zapalną chorobą skory, ktora na calym świecie przybiera rozmiar epidemii wśrod dzieci, z ciągle zwiekszającą sie zachorowalnością. Z uwagi na istotny wplyw atopowego zapalenia skory spoleczno-ekonomiczny i na jakośc zycia chorych dzieci oraz ich rodzin, przez cale dekady prowadzono badania kliniczne skoncentrowane na zapobieganiu chorobie, z ograniczonym skutkiem. Ostatnie postepy wiedzy na temat biologii skory sugerują, ze zaburzenia bariery skornej mogą byc kluczowymi czynnikami inicjującymi atopowe zapalenie skory i byc moze uczulenie na alergeny. Cel Celem badania bylo sprawdzenie, czy wsparcie bariery skornej od urodzenia jest skuteczną strategią zmniejszenia czestości wystepowania atopowego zapalenia skory u noworodkow z wysokim ryzykiem. Metody Przeprowadzono w Stanach Zjednoczonych i Wielkiej Brytanii kontrolowane badanie kliniczne z randomizacją u 124 noworodkow z wysokim ryzykiem atopowego zapalenia skory. Rodzicow dzieci w ramieniu eksperymentalnym poinstruowano o stosowaniu na cale cialo środka zmiekczającego co najmniej raz dziennie, rozpoczynając w ciągu 3 tygodni od urodzenia. Rodzice w ramieniu kontrolnym byli proszeni o niestosowanie środkow zmiekczających. Glownym miernikiem wykonalności badania byl odsetek rodzin wyrazających zgode na randomizacje. Pierwszorzedowym wynikiem klinicznym byla skumulowana czestośc atopowego zapalenia skory po 6 miesiącach, oceniana przez wyszkolonego badacza. Wyniki Ogolem 42% kwalifikujących sie rodzin wyrazilo zgode na randomizacje do badania. Wszystkie rodziny uczestniczące w ramieniu eksperymentalnym uznaly badaną interwencje za akceptowalną. Wykazano statystycznie istotny efekt zapobiegawczy po codziennym stosowaniu środka zmiekczającego w zakresie skumulowanej czestości wystepowania atopowego zapalenia skory, ze zmniejszeniem ryzyka wzglednego o 50% (ryzyko wzgledne 0,50; 95% CI, 0,28–0,9; p = 0,017). Nie odnotowano zadnych dzialan niepoządanych związanych ze stosowaniem środka zmiekczającego, a takze zadnych roznic dotyczących dzialan niepoządanych pomiedzy grupami badanymi. Wnioski Wyniki badania wykazują, ze stosowanie środka zmiekczającego od urodzenia stanowi wykonalną, bezpieczną i skuteczną strategie zapobiegania atopowemu zapaleniu skory. Jeśli zostanie to potwierdzone w wiekszych badaniach, stosowanie środkow zmiekczających od urodzenia staloby sie prostą i niską kosztowo interwencją, pozwalającą na zmniejszenie globalnego rozprzestrzenienia chorob alergicznych.

Atopic dermatitis is a chronic, pruritic inflammatory dermatosis that affects up to 25% of children and 2% to 3% of adults. This guideline addresses important clinical questions that arise in atopic dermatitis management and care, providing recommendations based on the available evidence. In this third of 4 sections, treatment of atopic dermatitis with phototherapy and systemic immunomodulators, antimicrobials, and antihistamines is reviewed, including indications for use and the risk-benefit profile of each treatment option.

Atopic dermatitis is a common and chronic, pruritic inflammatory skin condition that can affect all age groups. This evidence-based guideline addresses important clinical questions that arise in its management. In this second of 4 sections, treatment of atopic dermatitis with nonpharmacologic interventions and pharmacologic topical therapies are reviewed. Where possible, suggestions on dosing and monitoring are given based on available evidence.

Background Skin care remains a key component in atopic dermatitis (AD) management; there are no data available guiding optimal bathing recommendations. Objective This study aims to determine whether 15-minute to 20-minute baths followed by topical corticosteroid application (prehydration therapy) are effective for clearing moderate to severe AD. Methods In the Oregon Health & Science University outpatient dermatology clinic, a retrospective review was done of the health records of patients with AD seen first between January 1, 2007, and December 31, 2011, who were then reevaluated within 1 to 3 weeks of starting the therapy. Qualifying patients underwent the prehydration regimen and were reevaluated. The primary outcome was therapeutic response using the Investigators' Global Assessment Scale. Secondary outcomes were measured using the dynamic Treatment Response Scale. Of 110 distinct electronic records, 35 patients were excluded. At the initial visit, 75 patients were evaluated with the Investigators' Global Assessment Scale. Forty-eight patients (64%) were severe, and 27 patients (36%) were moderate. All subjects began prehydration therapy followed by topical corticosteroid. At follow-up visit in 1 to 3 weeks when using the patient's or provider's assessment of treatment response, 59 patients (79%) had marked improvement, and 3 patients (4%) were clear. Conclusions Prehydration followed by topical corticosteroid therapy seems to be a highly effective regimen that achieves rapid control of moderate to severe disease.

Atopic dermatitis (AD) is a chronic, pruritic, inflammatory dermatosis that affects up to 25% of children and 2% to 3% of adults. This guideline addresses important clinical questions that arise in the management and care of AD, providing updated and expanded recommendations based on the available evidence. In this first of 4 sections, methods for the diagnosis and monitoring of disease, outcomes measures for assessment, and common clinical associations that affect patients with AD are discussed. Known risk factors for the development of disease are also reviewed.

Background Atopic dermatitis (AD) is a common inflammatory skin disease with a global prevalence ranging from 3% to 20%. Patients with AD have an increased risk for complications after viral infection (eg, herpes simplex virus), and vaccination of patients with AD with live vaccinia virus is contraindicated because of a heightened risk of eczema vaccinatum, a rare but potentially lethal complication associated with smallpox vaccination. Objective We sought to develop a better understanding of immunity to cutaneous viral infection in patients with AD. Methods In a double-blind randomized study we investigated the safety and immunogenicity of live attenuated yellow fever virus (YFV) vaccination of nonatopic subjects and patients with AD after standard subcutaneous inoculation or transcutaneous vaccination administered with a bifurcated needle. Viremia, neutralizing antibody, and antiviral T-cell responses were analyzed for up to 30 days after vaccination. Results YFV vaccination administered through either route was well tolerated. Subcutaneous vaccination resulted in higher seroconversion rates than transcutaneous vaccination but elicited similar antiviral antibody levels and T-cell responses in both the nonatopic and AD groups. After transcutaneous vaccination, both groups mounted similar neutralizing antibody responses, but patients with AD demonstrated lower antiviral T-cell responses by 30 days after vaccination. Among transcutaneously vaccinated subjects, a significant inverse correlation between baseline IgE levels and the magnitude of antiviral antibody and CD4 + T-cell responses was observed. Conclusions YFV vaccination of patients with AD through the transcutaneous route revealed that high baseline IgE levels provide a potential biomarker for predicting reduced virus-specific immune memory after transcutaneous infection with a live virus.

Background Little is known about the epidemiology of eczema in adults. The goal of this study was to determine the prevalence of and associations with adult eczema in the United States. Methods We used the 2010 National Health Interview Survey from a nationally representative sample of 27,157 adults age 18 to 85 years. Results Overall, the 1-year prevalence of eczema was 10.2% (95% CI, 9.7% to 10.6%). The 1-year prevalence of eczema with asthma and/or hay fever was 3.2% (95% CI, 2.8% to 3.3%). Adult eczema was associated with higher prevalence of asthma ( P 2 test), more asthma attacks in the past year ( P P = .02). In multivariate models eczema prevalence was significantly higher in older participants; female subjects; those with Hispanic ethnicity, US birthplace, and higher level of household education; and those currently working (all P ≤ .02, logistic regression). Conclusions This study provides US population–based estimates of eczema prevalence and asthma associations in adults. The results suggest multiple demographic and socioeconomic influences on the US prevalence of adult eczema.

Atopic dermatitis (AD, also known as atopic eczema) is driven by a complex relationship between genetic predisposition and environmental exposures. We sought to determine the impact of specific climatic factors on the prevalence of AD in the United states. We used a merged analysis of the 2007 National Survey of Children’s Health (NSCH) from a representative sample of 91,642 children aged 0–17 years and the 2006–2007 National Climate Data Center and Weather Service measurements of relative humidity (%), indoor heating degree days (HDD), clear-sky UV indices, ozone levels, and outdoor air temperature. As a proxy for AD, we used an affirmative response to the NSCH survey question asking whether the participant’s child has been given a doctor diagnosis of “eczema or any other kind of skin allergy” in the previous 12 months. In multivariate models controlling for sex, race/ethnicity, age, and household income, eczema prevalence was significantly lower with the highest-quartile mean annual relative humidity (logistic regression, adjusted odds ratio (95% confidence interval)=0.82 (0.71–0.96), P=0.01) and issued UV index (0.73 (0.64–0.84), P

Subjects with atopic dermatitis (AD) have defects in antimicrobial peptide (AMP) production possibly contributing to an increased risk of infections. In laboratory models, vitamin D can alter innate immunity by increasing AMP production.To determine if AD severity correlates with baseline vitamin D levels, and to test whether supplementation with oral vitamin D alters AMP production in AD skin.This was a multi-centre, placebo-controlled, double-blind study in 30 subjects with AD, 30 non-atopic subjects, and 16 subjects with psoriasis. Subjects were randomized to receive either 4000 IU of cholecalciferol or placebo for 21 days. At baseline and day 21, levels of 25-hydroxyvitamin D (25OHD), cathelicidin, HBD-3, IL-13, and Eczema Area and Severity Index (EASI) and Rajka-Langeland scores were obtained.At baseline, 20% of AD subjects had serum 25OHD below 20 ng/mL. Low serum 25OHD correlated with increased Fitzpatrick Skin Type and elevated BMI, but not AD severity. After 21 days of oral cholecalciferol, mean serum 25OHD increased, but there was no significant change in skin cathelicidin, HBD-3, IL-13 or EASI scores.This study illustrated that darker skin types and elevated BMI are important risk factors for vitamin D deficiency in subjects with AD, and highlighted the possibility that seasonality and locale may be potent contributors to cathelicidin induction through their effect on steady state 25OHD levels. Given the molecular links between vitamin D and immune function, further study of vitamin D supplementation in subjects with AD is warranted.

Allergic contact dermatitis (ACD) may complicate the clinical course of atopic dermatitis (AD), and patch testing remains the criterion standard for diagnosing ACD. To date, there have been no guidelines or consensus recommendations on when and how to patch test individuals with AD. Failure to patch test when appropriate may result in overlooking an important and potentially curable complicating comorbidity. In this article, we present consensus recommendations regarding when to perform patch testing in the AD patient, best practices, and common pitfalls. Patch testing should be considered in AD patients with dermatitis that fails to improve with topical therapy; with atypical/changing distribution of dermatitis, or pattern suggestive of ACD; with therapy-resistant hand eczema in the working population; with adult- or adolescent-onset AD; and/or before initiating systemic immunosuppressants for the treatment of dermatitis. A suggested patch testing algorithm for AD patients is provided.

Background Antibody responses to the inactivated seasonal influenza vaccine in patients with atopic dermatitis (AD) have not been carefully characterized. Objective The primary objective of this study was to compare antibody responses to intradermal vaccination in participants with moderate/severe AD with those in nonatopic participants. Secondary objectives were to evaluate the effect of route of administration, Staphylococcus aureus skin colonization, and disease severity on vaccine response. Methods This was an open-label study conducted in the 2012-2013 influenza season at 5 US clinical sites. A total of 360 participants with moderate/severe AD or nonatopic subjects were assessed for eligibility, 347 of whom received intradermal or intramuscular vaccination per label and were followed for 28 days after vaccination. The primary outcome was the difference in the proportion of participants achieving seroprotection (hemagglutination-inhibition antibody titer ≥1:40 on day 28 after vaccination). Results Seroprotection rates for influenza B, H1N1, and H3N2 were not different (1) between participants with AD and nonatopic participants receiving intradermal vaccination and (2) between AD participants receiving intradermal and intramuscular vaccination. After intradermal, but not intramuscular, vaccination, participants with AD with S aureus colonization experienced (1) lower seroprotection and seroconversion rates and lower hemagglutination-inhibition antibody titer geometric mean fold increase against influenza B and (2) lower seroconversion rates against influenza H1N1 than noncolonized participants with AD. Conclusion Participants with AD colonized with S aureus exhibited a reduced immune response to influenza vaccination compared with noncolonized participants after intradermal but not intramuscular vaccination. Because most patients with AD are colonized with S aureus , intramuscular influenza vaccination should be given preference in these patients.

This article is a report of the fourth meeting of the Harmonising Outcome Measures for Eczema (HOME) initiative held in Malmo, Sweden on 23-24 April 2015 (HOME IV). The aim of the meeting was to achieve consensus over the preferred outcome instruments for measuring patient-reported symptoms and quality of life for the HOME core outcome set for atopic eczema (AE). Following presentations, which included data from systematic reviews, consensus discussions were held in a mixture of whole group and small group discussions. Small groups were allocated a priori to ensure representation of different stakeholders and countries. Decisions were voted on using electronic keypads. For the patient-reported symptoms, the group agreed by vote that itch, sleep loss, dryness, redness/inflamed skin and irritated skin were all considered essential aspects of AE symptoms. Many instruments for capturing patient-reported symptoms were discussed [ including the Patient-Oriented SCOring Atopic Dermatitis index, Patient-Oriented Eczema Measure (POEM), Self-Administered Eczema Area and Severity Index, Itch Severity Scale, Atopic Dermatitis Quickscore and the Nottingham Eczema Severity Score] and, by consensus, POEM was selected as the preferred instrument to measure patient-reported symptoms. Further work is needed to determine the reliability and measurement error of POEM. Further work is also required to establish the importance of pain/soreness and the importance of collecting information regarding the intensity of symptoms in addition to their frequency. Much of the discussion on quality of life concerned the Dermatology Life Quality Index and Quality of Life Index for Atopic Dermatitis; however, consensus on a preferred instrument for measuring this domain could not be reached. In summary, POEM is recommended as the HOME core outcome instrument for measuring AE symptoms.

Food allergy is an important public health problem that affects children and adults and may be increasing in prevalence. Despite the risk of severe allergic reactions and even death, there is no current treatment for food allergy: the disease can only be managed by allergen avoidance or treatment of symptoms. The diagnosis and management of food allergy also may vary from one clinical practice setting to another. Finally, because patients frequently confuse nonallergic food reactions, such as food intolerance, with food allergies, there is an unfounded belief among the public that food allergy prevalence is higher than it truly is. In response to these concerns, the National Institute of Allergy and Infectious Diseases, working with 34 professional organizations, federal agencies, and patient advocacy groups, led the development of clinical guidelines for the diagnosis and management of food allergy. These Guidelines are intended for use by a wide variety of health care professionals, including family practice physicians, clinical specialists, and nurse practitioners. The Guidelines include a consensus definition for food allergy, discuss comorbid conditions often associated with food allergy, and focus on both IgE-mediated and non-IgE-mediated reactions to food. Topics addressed include the epidemiology, natural history, diagnosis, and management of food allergy, as well as the management of severe symptoms and anaphylaxis. These Guidelines provide 43 concise clinical recommendations and additional guidance on points of current controversy in patient management. They also identify gaps in the current scientific knowledge to be addressed through future research.

Background: Contact hypersensitivity quantitative risk assessment (QRA) for fragrance ingredients is being used to establish new international standards for all fragrance ingredients that are potential skin sensitizers. Objective: The objective was to evaluate the retrospective clinical data on three fragrance ingredients in order to provide a practical assessment of the predictive value of the QRA approach. It is important to have data to assess that the methodology provides a robust approach for primary prevention of contact sensitization induction for fragrance ingredients identified as potential sensitizers. Methods: This article reviews clinical data for three fragrance ingredients cinnamic aldehyde, citral, and isoeugenol to assess the utility of the QRA approach for fragrance ingredients. Results: This assessment suggests that had the QRA approach been available at the time standards were established for these fragrance ingredients, the clinical response might have been noticeably improved. Prospectively, with the establishment of QRA-derived standards, there should be a continued downward trend in patch test-positive rates for cinnamic aldehyde, citral, and isoeugenol over time. Conclusion: While it is recognized that the availability of retrospective data is limited, a longitudinal review of these data gives confidence that the QRA approach should be an effective tool for primary prevention. This study also highlights the importance of continued active monitoring of clinical patch-test data for fragrance ingredients. (Less)

Summary Background Colonization with Staphylococcus aureus in atopic dermatitis (AD) is often associated with worsening of clinical symptoms. Staphylococcus aureus produces superantigens that contribute to cutaneous inflammation and corticosteroid (CS) resistance. Objectives To investigate the relationship between CS insensitivity, S. aureus colonization and superantigen production in AD, and to explore the efficacy of pimecrolimus cream in CS-insensitive AD. Methods This was a randomized, double-blind, vehicle-controlled, multicentre, parallel-group study. Seventy-three patients with AD, aged 2–49 years, who had a documented clinical insensitivity to topical CS, were recruited. The primary efficacy parameters combined laboratory (including S. aureus colonization, superantigens) and clinical assessments [including Eczema Area and Severity Index (EASI), whole body Investigator’s Global Assessment (IGA), pruritus assessment score, patient’s assessment score of disease control]. Results An increase in S. aureus counts correlated with worsening of clinical score (week 6 vs. baseline) when assessed by IGA, pruritus severity and patient assessment. The presence of superantigens correlated with this worsening. During the 6-week double-blind phase, disease improvement in the pimecrolimus cream group was demonstrated by decreasing EASI scores compared with vehicle. Mean EASI scores for the head and neck showed greater improvement in the pimecrolimus cream group than in the vehicle group at all observed time points. Conclusions In a cohort of patients with clinical insensitivity to CS there was a significant positive correlation between S. aureus and disease severity. Results suggest that for some of these patients, treatment with pimecrolimus cream 1% is useful, especially in the head/neck area.

Background: Atopic dermatitis (AD) is a chronic, inflammatory skin disease with a high prevalence and complex pathogenesis. The skin of AD patients is usually colonized by Staphylococcus aureus (S. aureus); its exotoxins may trigger or enhance the cutaneous inflammation. Several mediators are related to the AD immune imbalance and interleukin-18 (IL-18), an inflammatory cytokine, may play a role in the atopic skin inflammation. Aims: To evaluate peripheral blood mononuclear cells (PBMC) proliferation response to staphylococcal enterotoxins A (SEA) and B (SEB) and the levels of IL-18 in adults with AD. Methods: Thirty-eight adult patients with AD and 33 healthy controls were analysed. PBMC were stimulated with SEA and SEB, phytohemaglutinin (PHA), pokeweed (PWM), tetanus toxoid (TT) and Candida albicans (CMA). IL-18 secretion from PBMC culture supernatants and sera were measured by ELISA. Results: A significant inhibition of the PBMC proliferation response to SEA, PHA, TT and CMA of AD patients was detected (P ≤ 0.05). Furthermore, increased levels of IL-18 were detected both in sera and non-stimulated PBMC culture supernatants from AD patients (P ≤ 0.05). Conclusions: A decreased PBMC proliferation response to distinct antigens and mitogens (TT, CMA, SEA and PHA) in adults with AD suggest a compromised immune profile. IL-18 secretion from AD upon stimulation was similar from controls, which may indicate a diverse mechanism of skin inflammation maintained by Staphylococcus aureus. On the other hand, augmented IL-18 secretion from AD sera and non-stimulated cell culture may enhance the immune dysfunction observed in AD, leading to constant skin inflammation.

Background Recent genetic studies have demonstrated that filaggrin mutations, shown to underlie ichthyosis vulgaris (IV), may also predispose patients with atopic dermatitis to allergic respiratory disease. Objective Our objective was to determine whether the clinical presence of IV influences the severity and age at onset of atopic dermatitis or the probability of having allergic respiratory disease. Methods We reviewed data collected from the initial visits of 1187 patients with atopic dermatitis. Results Asthma symptoms were more common in atopic dermatitis patients with IV than in those without (39.9% vs 32.9%, odds ratio [OR] = 1.35, P = .050) and were most associated with severe IV (OR = 2.52, P = .002). This relationship remained after controlling for the baseline severity of atopic dermatitis. Clinical IV was also associated with symptoms of allergic rhinoconjunctivitis, earlier onset of atopic dermatitis, severity of atopic dermatitis, hyperlinear palms, and keratosis pilaris. Limitations Our limitations include subjective grading, few data points in some groups, and an inability to demonstrate causality. Conclusion These results suggest that clinical evidence of IV, irrespective of filaggrin genotype, serves as a potential marker for those patients with atopic dermatitis who develop allergic respiratory disease and a more severe skin phenotype.

One concern with traditional smallpox vaccination is inadvertent spread of virus to atopic or immunocompromised contacts. To reduce this risk, we tested the ability of povidone iodine to inactivate infectious virus at the vaccination site beginning at 7 days after transcutaneous smallpox vaccination. This ointment rapidly inactivated virus on the skin without reducing neutralizing antibody titers or antiviral T cell responses. Moreover, there was no delay in healing/eschar separation following povidone iodine application. Together, this indicates that administration of an antiviral/antimicrobial cream can effectively block virus shedding after traditional smallpox vaccination and reduce the risks of autoinoculation or contact spread.

Atopic dermatitis/eczema (AD) is a highly complex disease showing a clear increase in its incidence across all continents during the last decades 1, 2. It is the most common skin disease and has, almost other allergic diseases, a substantial socioeconomic impact 3. The complexity of the underlying mechanisms explains the wide spectrum of the clinical phenotype such as the age of onset, natural history, range of sensitization, provocation factors, clinical appearance, severity, and therapeutic response. Moreover, progress in the last years 4 has also highlighted the potential role of the skin microbiome, neuro‐immunological signals, and epigenetic regulation in the modulation of the disease, adding another level of complexity. This situation calls for a more differentiated approach in our efforts to understand the pathophysiology and to develop new preventative and therapeutic strategies better tailored for the subsets of this complex phenotype. This is particularly true when we consider the infantile and childhood onsets of AD, which are currently regarded as the first step of the feared atopic march including allergic rhinitis and/or asthma 5, 6. Thus, AD should more be considered as a systemic disease with a number of relevant comorbidities 7, 8, which will greatly benefit from new developments in the era of precision medicine 9. In July 2015, a group of 63 scientists and clinicians from 13 countries gathered under the auspices of the Christine Kuhne – Center for Allergy Research and Education (CK‐CARE) for the 3rd Global Allergy Forum in Davos, Switzerland. As in the past, the scientists intensely discussed key issues relevant in the field of allergy and AD 10, 11. The aim of the Think Tank meeting in 2015 was to define and discuss new strategies in research and education in AD, which will pave the way for the precision medicine pathways in AD. This document is not meant to be a comprehensive list of research areas but rather summarizes the main results of the working groups in charge of the six most important fields considered for this meeting.

Pimecrolimus cream 1 % is a topical calcineurin inhibitor for the treatment of atopic dermatitis. Minimal systemic exposure to pimecrolimus has been previously observed in Caucasian pediatric patients treated with the cream twice daily for up to 1 year. The objective of this open-label, non-comparative, multicenter study was to assess the systemic exposure, tolerability and efficacy of pimecrolimus cream 1 % when used twice daily for 3 weeks in pediatric patients of Japanese background. The patient cohort consisted of 17 Japanese infants and children (age range, 3.6 months to 11.6 years) with atopic dermatitis of at least mild severity affecting >10% of the total body surface area (range, 10-48%). Pimecrolimus cream 1 % was applied twice daily for 3 weeks. Blood levels of pimecrolimus were determined on days 1, 10 and 22. Safety and tolerability were evaluated by monitoring adverse events, laboratory parameters, physical condition and vital signs. Efficacy parameters included the Eczema Area and Severity Index, the Investigators' Global Assessment and the pruritus score. The median exposure to pimecrolimus cream 1 % was 22 treatment days (range, 9-29 treatment days). Pimecrolimus blood concentrations were

Summary Background The safety of topical therapies for atopic dermatitis (AD), a common and morbid disease, has recently been the focus of increased scrutiny, adding confusion as how best to manage these patients. Objectives The objective of these systematic reviews was to determine the safety of topical therapies for AD. Methods Databases searched included: OVID Medline, Medline In-Process and Other Non-Indexed Citations, Embase, and the Cochrane Central Register of Controlled Trials. In addition to the articles identified by this search, investigators were also referred to a list of links (most recently updated 25 September 2005) to recent Food and Drug Administration (FDA) studies, reports and meetings regarding the topical calcineurin inhibitors for further potential references. Only fully published papers available in English and data obtained from FDA sites were included. Furthermore, the criteria for inclusion and exclusion for each systematic review were further evaluated at a meeting of all of the content and evidence-based medicine experts participating in this process and alteration of the inclusion criteria was done at that time when it was felt necessary to avoid inclusion of lower-quality data in the review. Qualitative review of the abstracted data was performed and reviewed at a meeting of all of the content and evidence-based medicine experts. Results While systemic exposure to these topical agents does occur, physiological changes appear to be uncommon and systemic complications rare and have only been found with use of topical corticosteroids. Conclusions Based on the data that are available the overall safety of AD therapies appears to be good with the only documented systemic side-effects of therapy those occasionally seen with use of topical corticosteroids.

This review summarizes the general approach and philosophy of managing difficult atopic dermatitis. There are as many regimens as there are physicians, but too many fail to provide patients with adequate relief. This leads to the wasteful alternative - an allergy-seeking behavior that makes caring for these patients even more complicated. If we, as dermatologists, provide rational counseling on prevention and skin care along with effective, stable, anti-inflammatory therapy, our patients may stop seeking irrational approaches. The new flood of information relating to epidermal barrier provides a basis for seeking and treating xerotic conditions earlier during infancy with the hope that the increasing problems with atopic dermatitis and asthma may be lessened with simple and safe measures. Esta revisão resume a abordagem geral e a filosofia na conduta de casos difíceis de dermatite atópica. Existe uma variedade de tratamentos, assim como de médicos, mas muitos falham e não propiciam um alívio adequado aos pacientes, o que leva a uma alternativa dispendiosa, ou seja, um atitude que visa procurar alergias e complica ainda mais o tratamento desses pacientes. Se nós, como dermatologistas, oferecermos um aconselhamento racional sobre prevenção e cuidados com a pele, junto com uma terapia antiinflamatória eficaz e estável, nossos pacientes irão parar de procurar abordagens irracionais. O novo fluxo de informações sobre a barreira epidérmica propicia uma base para investigar e tratar as doenças xeróticas em uma fase mais precoce durante o primeiro ano de vida, com a esperança de que os problemas crescentes relacionados à dermatite atópica e asma possam ser atenuados com medidas simples e seguras.

Severe atopic dermatitis (AD) often cannot be adequately controlled with topical agents. The continuous use of current systemic therapies for AD is limited by end-organ toxicities. A safe and effective systemic therapy for patients with recalcitrant AD is greatly needed.To evaluate the potential safety and efficacy of efalizumab, an inhibitor of T cell activation and migration, in adults with severe AD.An investigator-initiated, prospective, open-label, pilot study was conducted involving ten subjects with severe AD. Subjects received an initial conditioning subcutaneous dose of efalizumab of 0.7 mg/kg followed by 1.0 mg/kg weekly for another 11 weeks for a total of 12 doses. The primary efficacy outcome was the change in the mean Eczema Area and Severity Index (EASI) score from baseline as measured at week 12. Monitoring of adverse events continued for 8 weeks after discontinuation of therapy.EASI scores improved from a mean baseline score of 37.1 +/- 13.5 to 17.6 +/- 14.5 at week 12 (52.3% improvement; P.0001). Six out of ten subjects reached at least a 50% improvement in EASI score by week 12. Pruritus levels decreased from 6.9 cm +/- 1.8 cm to 4.9 cm +/- 2.5 cm utilizing a visual analogue score (P.015). Overall, efalizumab was well tolerated. There were three significant adverse events during the course of this study, including thrombocytopenia, viral gastroenteritis, and a subject with worsening of disease beyond baseline levels after drug discontinuation.It is difficult to apply these findings to larger populations of patients with AD because this study lacked a control group and involved a small number of subjects with very severe disease. Long-term efficacy and safety of efalizumab in this population is not known.Efalizumab therapy resulted in significant clinical improvements in six of ten subjects with severe AD. Efalizumab may serve as a good alternative to current systemic immunosuppressants used for AD; however, double-blind placebo-controlled studies are needed to test its efficacy and safety.

An evaluation and review of a structurally related group of fragrance materials. (C) 2007 Published by Elsevier Ltd.

An evaluation and review of a structurally related group of fragrance materials.

BACKGROUND AND OBJECTIVES: Children with atopic dermatitis (AD) have a higher risk for development of food allergies. The objective of this study was to examine incidence of food allergy development in infants with AD and the predictive value of food-antigen–specific immunoglobulin E measurements. METHODS: This trial examined the long-term safety and efficacy of pimecrolimus cream 1% in >1000 infants (3–18 months) with mild-to-severe AD without a history of food allergy. Food allergy development was followed throughout a 36-month randomized double-blind phase followed by an open-label (OL) phase up to 33 months. Additionally, sIgE for cow’s milk, egg white, peanut, wheat, seafood mix, and soybean was measured by ImmunoCAP at baseline, end of the double-blind phase, and end of OL phase. RESULTS: By the end of the OL phase, 15.9% of infants with AD developed at least 1 food allergy; allergy to peanut was most common (6.6%), followed by cow’s milk (4.3%) and egg white (3.9%). Seafood, soybean, and wheat allergies were rare. Levels of sIgE for milk, egg, and peanut increased with severity of AD, as determined by Investigator’s Global Assessment score. We assigned sIgE decision points for the 6 foods and tested their ability to predict definite food allergy in this population. Positive predictive values for published and newly developed sIgE decision points were low ( CONCLUSIONS: In a large cohort of infants at risk for development of food allergy, sIgE levels were not clinically useful for predicting food allergy development.

Because of the significant emotional and psychosocial impact of chronic pruritus, it is important to accurately assess and measure itch severity. This study aims to validate and apply clinically meaningful bands to the ItchyQuant, an illustrated self-report numeric rating scale (NRS) for itch severity. A total of 76 adults with chronic pruritus were recruited. Participants rated their itch on the ItchyQuant, on a traditional 11-point NRS, and with verbal categorizations (no, mild, moderate, or severe). There was a significant, high correlation between the ItchyQuant and NRS (0.92, P0.0001), demonstrating concurrent validity. Significantly more patients (47.2%) preferred the ItchyQuant than the NRS (23.6%) or had no preference (29.2%), P = 0.0015. Significantly more patients found the ItchyQuant easier to use (45.8%) than the NRS (20.8%) or had no preference (33.3%), P = 0.008. The set of clinically meaningful bands with the highest weighted kappa coefficient of agreement (κ = 0.69) was as follows: 0 (no itch), 1-3 (mild itch), 4-7 (moderate itch), 8-10 (severe itch). The ItchyQuant is a clinically meaningful measure of itch severity, demonstrating face and concurrent validity, that many patients prefer and find easier to use when compared with a traditional NRS. We suggest that the ItchyQuant can be added to the existing armamentarium of itch severity scales. We plan to investigate the ItchyQuant further in cognitively challenged populations.