Pediatric Atopic Dermatitis Patients Research Articles

Knowledge, attitudes, and practices in adult patients and parents of pediatric atopic dermatitis patients: a cross-sectional study

Knowledge, attitudes, and practices in adult patients and parents of pediatric atopic dermatitis patients: a cross-sectional study

Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to

Background Baricitinib, an oral selective Janus kinase inhibitor, improved clinical signs and symptoms of moderate-to-severe atopic dermatitis (AD) at week 16 in the phase 3 pediatric study BREEZE-AD-PEDS. Objective To assess longer-term efficacy and safety of baricitinib in pediatric patients aged 2 to <18 years. Methods In BREEZE-AD-PEDS long-term extension, responders and partial responders (validated Investigator Global Assessment-Atopic Dermatitis [vIGA-AD®] 0/1/2) at Week 16 remained on double-blind treatment to which they were randomized (placebo, baricitinib [1-mg equivalent, 2-mg equivalent, or 4-mg equivalent); non-responders (vIGA-AD 3 or 4) at Week 16 transitioned to open-label baricitinib 4-mg equivalent. Safety was summarized for all randomized patients who received ≥1 dose of study treatment. Results In total 467 patients received baricitinib for 750.7 patient-years. Proportion of responders/partial responders (at Week 16) who achieved vIGA-AD 0/1 at Week 52 was greater for baricitinib 4-mg equivalent (56.8%) versus all other treatment groups (42.2%, 47.7%, and 39.7% for 2-mg equivalent, 1-mg equivalent, and placebo, respectively). Most treatment-emergent adverse events were mild/moderate in severity. No deaths, pulmonary emboli, deep vein thromboses or arterial thrombotic events, major adverse cardiovascular events, malignancies, tuberculosis events, or gastrointestinal perforations were reported. Conclusions Baricitinib demonstrated sustained long-term efficacy. No new safety signals were identified. Trial Registration ClinicalTrials.gov Identifier: NCT03952559

Dupilumab Efficacy and Safety Assessment in the Treatment of Atopic Dermatitis in Pediatric Patients: A Systematic Review

Dupilumab Efficacy and Safety Assessment in the Treatment of Atopic Dermatitis in Pediatric Patients: A Systematic Review

Efficacy of a Video Education Program Regarding Basic Skin Care in Pediatric Atopic Dermatitis: A Randomized Controlled Trial.

Basic skin care education holds the potential to improve clinical outcomes in pediatric atopic dermatitis (AD). However, evidence is lacking on the efficacy of video education for patient guardians in Thailand to reduce AD disease severity. To compare the efficacy of a video education program for guardians of pediatric AD patients versus a control group by assessing the severity score of AD (SCORAD), transepidermal water loss (TEWL), and skin hydration (SH). A single-blinded, randomized controlled trial was conducted at a tertiary hospital from June 2023 to February 2024, involving AD patients aged < 18 years and their guardians. Both groups received standard treatment, and the educational group received an additional video education program. SCORAD, TEWL, SH, pruritus, sleeplessness, and parental/guardian confidence and knowledge accuracy were assessed at enrollment and a 4-week follow-up. Seventy patients (educational:control group, 34:36) with a median age of 3.1 years were enrolled. The groups exhibited no significant demographic or disease severity differences between them. At follow-up, the educational group showed significant SCORAD improvement compared to the control group (mean difference -10.93 [95% CI -16.92--4.95]; p < 0.001). SH (mean difference 3.82 [95% CI -2.7-10.33]; p = 0.25) and TEWL (mean difference -1.24 [95% CI -5.72-3.24]; p = 0.58) did not differ significantly. Video education demonstrated efficacy in significantly reducing SCORAD. While there were improvements in SH and TEWL in patients in the education group, these improvements were not statistically significant. Further investigation with a larger sample size is warranted. Thai Clinical Trials Registry (TCTR): TCTR20230524001.

Effect of Omega-3 Polyunsaturated Fatty Acid Supplementation on Clinical Outcome of Atopic Dermatitis in Children.

The use of omega-3 fatty acids (omega-3 FA) in the treatment of atopic dermatitis (AD) is an area of ongoing research. Some studies suggest that dietary supplementation with omega-3 FA can help manage symptoms of AD by reducing lesion severity, skin inflammation, dryness and itching, while others show no significant beneficial effect. The aim of this study was to evaluate the effect of omega-3 FA from fish oil in combination with gamma-linolenic acid (GLA) from blackcurrant seed oil in children with AD. This is a longitudinal, prospective, randomized, triple blind, placebo-controlled parallel clinical trial. The study was conducted during the 2-year period throughout autumn, winter, and spring, avoiding the summer when AD usually improves. Children were randomized to receive the active study product (Mega Kid®) containing a specific blend of omega-3 and omega-6 fatty acids or placebo. The primary outcomes were changes in severity of AD measured using SCORing Atopic Dermatitis (SCORAD), patient-oriented SCORAD (PO-SCORAD) and the difference in topical corticosteroid (TCS) use. The secondary outcomes were changes in itch intensity, sleep quality and Family Dermatology Life Quality Index (FDLQI). Data were analyzed for 52 children (26 in the intervention group and 26 in the placebo group). In children receiving the active product, intention-to-treat analysis showed that after 4 months of treatment, there was a significant decrease in the SCORAD index (from median 42 to 25, p < 0.001) and the use of topical corticosteroids (from median 30 to 10 mg/month, p < 0.001), but also significant improvements in itch, sleep quality, and overall quality of life. Omega-3 fatty acids in combination with GLA and vitamin D may decrease symptoms and were associated with an improvement clinical picture of AD in children. Therefore, we can conclude that supplementation with this specific combination could be considered a safe and effective intervention that may significantly reduce the severity of AD in pediatric patients.

Dupilumab induces a significant decrease of food specific immunoglobulin E levels in pediatric atopic dermatitis patients.

Dupilumab induces a significant decrease of food specific immunoglobulin E levels in pediatric atopic dermatitis patients.

Dupilumab treatment decreases MBC2s, correlating with reduced IgE levels in pediatric atopic dermatitis

BackgroundA preference for type 2 immunity plays a central role in the pathogenesis of atopic dermatitis (AD). Dupilumab, a monoclonal antibody targeting the IL-4α receptor subunit, inhibits IL-4 and IL-13 signaling. These cytokines contribute significantly to IgE class switch recombination in B-cells, critical in atopic diseases. Recent studies indicate IgG+CD23hiIL-4RA+ memory B-cells (MBC2) as IgE-producing B-cell precursors, linked to total IgE serum levels in atopic patients. Total IgE serum levels decreased during dupilumab treatment in previous studies. ObjectiveTo assess the effects of dupilumab treatment in comparison to alternative therapies on the frequency of MBC2 and the correlation to total IgE levels in pediatric patients with AD. MethodsPediatric patients with AD, participating in an ongoing trial, underwent randomization into three treatment groups: dupilumab (n=12), cyclosporine (n=12), or topical treatment (n=12). Plasma and Peripheral Blood Mononuclear Cells (PBMCs) were collected at baseline (T0) and after 6 months (T6). Flow cytometry was employed for PBMC phenotyping, ELISA was utilized to assess total IgE levels in plasma. For detailed Methods, please see the Methods section in this article's Online Repository at www.jacionline.org ResultsOur findings revealed a significant reduction in MBC2 frequency and total IgE levels among patients treated with dupilumab. Additionally, a significant correlation was observed between MBC2s and total IgE levels ConclusionSystemic blocking of the IL-4RA subunit leads to a decrease in circulating MBC2 cells and total IgE in pediatric AD patients. Our findings unveil a novel mechanism through which dupilumab exerts its influence on the atopic signature.

Reduced atopic march risk in pediatric atopic dermatitis patients prescribed dupilumab versus conventional immunomodulatory therapy: A population-based cohort study

Dupilumab effectively treats atopic dermatitis (AD); however, its role in halting the atopic march remains uncertain. To investigate dupilumab's effect on atopic march in pediatric AD patients versus conventional immunomodulators. This retrospective cohort study utilized data from the TriNetX US Collaborative Network (2011-2024). Pediatric AD patients (≤18years) were categorized into DUPI-cohort (newly prescribed dupilumab) or CONV-cohort (prescribed conventional immunomodulators without dupilumab). After 1:1 propensity-score matching, we analyzed atopic march progression, defined by the incident asthma or allergic rhinitis (AR). Cumulative incidence was plotted using Kaplan-Meier, with risk assessment via Cox regression. The study included 2192 patients in each cohort. The 3-year cumulative incidence of atopic march progression was lower in the DUPI-cohort than the CONV-cohort (20.09% vs 27.22%; P<.001). The DUPI-cohort demonstrated significant risk reduction in atopic march progression (hazard ratio [HR] 0.68, 95% CI 0.55-0.83), individual asthma (HR 0.60, 0.45-0.81), and individual AR (HR 0.69, 0.54-0.88). Younger patients on dupilumab exhibited a greater risk reduction for atopic march progression and individual asthma, contrasting with the opposite age-related pattern for individual AR. Observational study. Among pediatric AD patients, dupilumab was associated with reduced risk of atopic march progression compared with conventional therapies.

Effect of dupilumab on asthma and aeroallergen sensitization in pediatric atopic dermatitis patients: Results of the BioDay registry.

Atopic dermatitis (AD) is frequently associated with asthma and allergic rhinitis (AR). Dupilumab is an effective treatment for pediatric AD, although the effect on atopic comorbidities in pediatric AD patients is limited. To investigate the prevalence of asthma and AR in pediatric AD patients starting dupilumab treatment and to evaluate the effect of dupilumab on these comorbidities. This study included pediatric AD patients (aged 3-17 years) treated with dupilumab between 2019 and 2023. Patients were screened at baseline by a pulmonologist for the presence of asthma and AR. Screening included evaluation of medical history and current symptoms, spirometry (including Forced Expiratory Volume in 1 s (FEV1)), Fractional exhaled Nitric Oxide (FeNO), and measurement of aeroallergen-specific IgE levels. In patients diagnosed with comorbid asthma and/or AR, measurements were repeated at weeks 16 and 52. Spirometry measurements, FeNO, and aeroallergen-specific IgE levels during treatment were analyzed using a covariance pattern model. Eighty-four patients were included. Asthma was diagnosed in 50 patients (59.5%) and AR in 72 patients (85.7%). Baseline FeNO levels were elevated in both patients with (29.0 ppb (95% CI 22.0-54.0)) and without asthma (26.0 ppb (95% CI 22.0-30.0)). During treatment, FeNO levels decreased (p < .001) and FEV1 scores increased (p < .001) in patients with asthma. In patients with asthma and/or AR, all aeroallergen-specific IgE levels decreased between 61.3% and 89.1% at 52 weeks of treatment. One year of dupilumab treatment, primarily indicated for AD, resulted in a significant improvement in comorbid asthma and a profound decrease in aeroallergen-specific IgE levels in patients with asthma and/or AR.

Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study.

Pediatric patients with moderate-to-severe atopic dermatitis (AD) often experience a high disease burden and have a high risk of persistent disease. Standard-of-care immunosuppressive systemic treatments have been used off-label for AD in pediatric patients despite concerns for suboptimal safety with continuous use and risk of relapse upon discontinuation. The biologic agent dupilumab is the first systemic treatment approved for moderate-to-severe AD in children as young as 6 months. Long-term safety and efficacy data in this patient population are needed to inform continuous AD management. The purpose of this work was to determine the long-term safety and efficacy of dupilumab treatment up to 1 year in an open-label extension (OLE) study [LIBERTY AD PED-OLE (NCT02612454)] in children aged 6 months to 5 years with moderate-to-severe AD who previously participated in the 16-week, double-blind, phase 3 LIBERTY AD PRESCHOOL trial (NCT03346434 part B; parent study) and were subsequently enrolled in PED-OLE. In PED-OLE, patients received dupilumab every 4 weeks according to a weight-tiered regimen (body weight ≥ 5 kg to < 15 kg: 200 mg; ≥ 15 kg to < 30 kg: 300 mg). Data for 142 patients were analyzed, 60 of whom had completed the 52-week visit at time of database lock. Mean age at baseline was 4.1 y [SD, 1.13; range, 1.0-5.9 years]. A majority (78.2%) of patients reported ≥ 1 treatment-emergent adverse event (TEAE), most of which were mild or moderate and transient. The most frequently reported TEAEs were nasopharyngitis (19.7%), cough (15.5%), and pyrexia (14.1%). One TEAE led to treatment discontinuation (severe urticaria, which resolved in 1 day). By week 52, 36.2% of patients had achieved an Investigator's Global Assessment score of 0/1 (clear/almost clear skin), and 96.6%, 79.3%, and 58.6% had at least 50%, 75%, or 90% improvement, respectively, in Eczema Area and Severity Index scores. Consistent with results seen in adults, adolescents, and older children (aged 6-11 years), treatment with dupilumab for up to 1 year in children aged 6 months to 5 years with inadequately controlled moderate-to-severe AD demonstrated an acceptable long-term safety profile and sustained efficacy. These results support the long-term continuous use of dupilumab in this patient population. ClinicalTrials.gov Identifiers: NCT02612454 and NCT03346434 (part B).

Patch test in Brazilian children with a clinical diagnosis of atopic dermatitis: a cross-sectional study using an extended patch test battery.

Atopic dermatitis (AD) is a chronic and relapsing inflammatory skin disease mainly affecting children. Similarly, Allergic contact dermatitis (ACD) is an inflammatory skin disease, but unlike AD it results from direct exposure to an external agent. Theoretically, the impaired skin barrier facilitates the penetration of potential allergens. Therefore, AD patients are at risk for an associated ACD, exacerbating their skin condition. Because eczema is similar, performing a patch test (PT) for the differential diagnosis is essential. In this cross-sectional transversal study, we performed a PT with 30 sensitizers in 26 children with AD, selected according to established criteria for suspected ACD, and treated at an AD center of a pediatric university hospital in Rio de Janeiro. Clinical presentation, patient profile, main sensitizers, and frequency of ACD caused by therapeutic skincare products were evaluated. In all, 23 (88.5%) patients reacted to at least one allergen, 21 (80.7%) had a relevant positive patch test, and 15 (57.7%) were polysensitized. The main positive sensitizers were nickel (38.5%), blue disperse (30.8%), fragrance mix (30.8%), and neomycin (23.1%). Nineteen (73%) patients reacted to substances present in therapeutic or skincare products. Our data underscore the importance of performing a PT in AD children whose eczema has atypical distribution. The expressive percentage of positive tests, especially of allergens in skincare products, indicates the constant need to review the proposed treatments. Therefore, we recommend a specific and expanded PT battery for pediatric AD patients, including a negative control, to increase sensitivity for diagnosing ACD.

Patients' and Caregivers' Experiences Navigating the Burden of Atopic Dermatitis in Argentina.

Background and Objectives: Little is known about patients' and caregivers' experiences with atopic dermatitis (AD) in Argentina, so a survey was administered to learn more. Materials and Methods: A 53-item anonymous survey was administered in Spanish to adult AD patients (n = 334) and caregivers (n = 339) of pediatric AD patients in Argentina (total n = 673). Demographics, healthcare provider information, financial burden, disease severity, disease burden, level of disease-specific education, and experience with shared physician/patient decision making were collected. Linear and logistic regression models were used for statistical comparisons. Results: Survey respondents were overwhelmingly female (90.8%), as was the overall patient population (72.8%). Patients were seen mostly by healthcare specialists (66.8% dermatologists, 13.5% pediatricians, 7.7% allergists, and 7.2% general practitioners). Only 2.8% of respondents reported no symptoms, while 33.3%, 52.4%, and 11.5% reported mild, moderate, and severe AD disease, respectively. Anxiety/depression and pain/discomfort were the most impactful on respondents' quality of life. Caregivers of children with moderate to severe AD and adult patients with severe AD reported a significant financial burden, including using savings or not purchasing food or other essentials to afford medical care. Few people reported receiving disease-specific education or having their own treatment priorities taken into consideration. For adult patients, receiving disease education and being asked about treatment priorities were associated with higher treatment satisfaction and AD control. Discussion: Mental health, pain/discomfort, and financial worries are the most important burdens for adult AD patients and caregivers of children with AD in Argentina. We recommend prioritizing disease-specific education and shared decision making to improve AD care in Argentina.

Efficacy of aprepitant for refractory pruritus in patients with epidermolysis bullosa and atopic dermatitis: A retrospective study.

At a single-center pediatric hospital, the neurokinin-1 receptor antagonist aprepitant was used to treat refractory pruritus in epidermolysis bullosa (EB) and atopic dermatitis (AD). Thirty-seven patients were included (24 EB patients, 13 AD patients), ages 10 months to 37 years. 58% (14/24) of patients with EB and 85% (11/13) of patients with AD reported aprepitant was effective in decreasing their pruritus, with age-related differences in efficacy observed in EB patients, and access to the medication by insurance denial or availability of the drug as a barrier to use. Aprepitant shows promise in controlling refractory pruritus in pediatric EB and AD patients and deserves further study.

Post-hoc safety/efficacy analyses from pediatric delgocitinib atopic dermatitis trials.

Delgocitinib ointment is usually recommended for use in children at a concentration of 0.25%. However, there are no clear criteria for dosing, except that a 0.5% formulation may also be used, depending on symptom severity. Treatment of atopic dermatitis is based on combinations of topical corticosteroids, tacrolimus ointment, and delgocitinib ointment, but there are no reports on the safety of delgocitinib ointment when used in combination with other drugs. This is a post-hoc analysis of data from two delgocitinib ointment trials with pediatric atopic dermatitis patients. The efficacy and safety of the 0.25% and 0.5% formulations were compared. Efficacy and safety were evaluated after up to 4 and 56 weeks of treatment, respectively. The safety of delgocitinib ointment when used in combination with topical corticosteroids and/or tacrolimus ointment was investigated. The dose-response relationship was examined according to baseline disease severity. The proportions of subjects with mild disease who achieved cumulative investigator's global assessment of 0 (clear) or 1 (almost clear) were 46.2% (0.25% ointment), 71.4% (0.5% ointment), and 7.7% (vehicle). For subjects with moderate to severe disease, the corresponding proportions were 19.0%, 20.0%, and 0.0%, respectively. No overall differences were seen in the safety profiles of the 0.25% and 0.5% delgocitinib ointment doses, or in the safety profiles of the two doses relating to disease severity or to concomitant use of topical corticosteroids and/or tacrolimus ointment. These analyses indicate that after up to 4 weeks of treatment, delgocitinib 0.5% ointment may be more effective than the 0.25% dose for mild atopic dermatitis, and that after up to 56 weeks of treatment, delgocitinib is well tolerated in a pediatric trial population when used as prescribed in combination with topical corticosteroids and/or tacrolimus ointment.

Burden of atopic dermatitis in paediatric patients: aninternational cross-sectional study.

Few large-scale international studies have broadly characterized the burden of atopic dermatitis (AD) across age groups among children and adolescents. To better characterize the AD burden in paediatric patients by disease severity. This cross-sectional, web-based survey of paediatric patients (6 months to < 18 years old) was conducted in 18 countries representing North America, Latin America, Europe, Middle East/Eurasia and East Asia. Patients with diagnosed AD were identified based on the International Study of Asthma and Allergies in Childhood criteria and self-/parent-report of ever being told by a physician that they or their child had eczema. AD severity was assessed using the Patient-Oriented Eczema Measure and Patient Global Assessment. Outcomes included measures of itch, skin pain, sleep, health-related quality of life (HRQoL), missed school days and atopic comorbidities. The survey included 1489 children aged 6 months to < 6 years; 2898 children aged 6 to < 12 years; and 3078 adolescents aged 12 to < 18 years diagnosed with AD. Although the burden of mild AD was substantial, paediatric patients with moderate or severe AD had more itch, skin pain, sleep problems and impaired HRQoL, and missed more school days relative to those with mild AD; greater burden was observed among those with severe relative to moderate AD. At least one atopic comorbidity was present in 92.5% of all respondents. These results highlight the burden of AD in paediatric patients, especially those with moderate-to-severe disease, and suggest the need for assessments that include the impact of AD on function and daily life.

Lebrikizumab: a novel approach in managing atopic dermatitis in pediatric patients

Atopic dermatitis is a prominent dermatological condition in children that frequently affects their lifestyle. Conventional treatments frequently prove inadequate, necessitating the use of biological agents like Lebrikizumab to address the condition at its core pathophysiological level. The introduction of biologic drugs has broadened the spectrum of treatment options for patients with moderate to severe atopic dermatitis, especially those who have not achieved satisfactory results with conventional monotherapy or combination therapies, or those with contraindications to systemic immunosuppressive agents. Lebrikizumab appears to be a promising option for the treatment of atopic dermatitis, showing a strong response in clinical trials. It offers the potential for improved long-term efficacy and a reduction in adverse effects. This article provides an overview of Lebrikizumab's role in addressing the pathogenesis of atopic dermatitis and highlights its current advancements.

Biologicals for pediatric patients with atopic dermatitis: practical challenges and knowledge gaps

Biologicals are becoming increasingly important in the therapeutic landscape of pediatric patients with moderate-to-severe atopic dermatitis (AD). Currently, dupilumab and tralokinumab are registered for the treatment of moderate-to-severe AD, and novel biologicals are expected to follow. Dupilumab was the first biological registered for AD in pediatric patients and was recently approved for patients aged six months to five years. Current and emerging biologicals may address the unmet need for effective and safe treatment options for pediatric AD patients, however, little is known about the practical implementation of biologicals in infants and preschoolers (aged <6 years), including the timing of treatment initiation, discontinuation, and long-term administration of the subcutaneous injections. Currently, only a small number of biologicals are approved for the treatment of infants and preschoolers for other inflammatory diseases. Consequently, data on the practical implementation of biological treatment remain scarce. In addition, long-term effects, impact on co-morbidities, and impact on live-accentuated vaccination are still unknown. With the introduction of biologicals for AD from the age of six months, potential challenges within the implementation of biologicals may arise. Therefore, we aim to discuss current practical challenges and knowledge gaps of the treatment with biologicals in infants and preschoolers with AD.

Improvements in Gut Microbiome Composition Predict the Clinical Efficacy of a Novel Synbiotics Formula in Children with Mild to Moderate Atopic Dermatitis.

Atopic dermatitis (AD) is a common chronic inflammatory skin disease with a significant association with various type-2 inflammation-related comorbidities. Ongoing research suggests the crucial involvement of gut microbiome, especially in childhood onset AD, and hence, probiotics have emerged as a potential non-steroid-based therapeutics option to complement existing AD management plans. In order to delineate the impact of probiotics in the gut microbiome of pediatric AD patients from southern China, targeted 16S rRNA sequencing and thorough bioinformatic analysis were performed to analyze the gut microbiome profiles of 24 AD children after taking an orally administered novel synbiotics formula with triple prebiotics for 8 weeks. A notable improvement in Eczema Area and Severity Index (EASI) (p = 0.008) was observed after taking an 8-week course of probiotics, with no adverse effects observed. The relative abundances of key microbial drivers including Bacteroides fragilis and Lactobacillus acidophilus were significantly increased at week 8. We also found that the positive responsiveness towards an 8-week course of probiotics was associated with improvements in the gut microbiome profile with a higher relative abundance of probiotic species. Over-represented functional abundance pathways related to vitamin B synthesis and peptidoglycan recycling may imply the underlying mechanism. In summary, our study suggests how the gut microbial landscape shifts upon probiotic supplementation in AD children, and provides preliminary evidence to support targeted probiotic supplementation for the management of childhood AD.

476 High loading-dose of dupilumab rapidly controls pruritus in pediatric atopic dermatitis patients

476 High loading-dose of dupilumab rapidly controls pruritus in pediatric atopic dermatitis patients

Atopic Dermatitis and its Management by the First Contact Doctor

Atopic dermatitis is a chronic inflammatory skin disease that affects a large number of pediatric patients between 2 and 17 years of age. Typical symptoms include intense itching, erythema, and scaling of the skin. Atopic dermatitis has been found to be associated with decreased quality of life for patients and their families. Diagnosis is made by clinical evaluation and differential diagnosis with other dermatologic diseases. Treatment is based on the severity of the disease and the age of the patient. Topical treatments are the first line of treatment, while systemic treatments are reserved for patients with severe atopic dermatitis who do not respond to topical treatments. In addition, other treatments, such as light therapy, biological therapy and allergen-specific immunotherapy, have been evaluated in patients with atopic dermatitis. A multidisciplinary approach and appropriate patient and family education are critical to the successful management of atopic dermatitis in pediatric patients.