Clinical approach to the patient with refractory atopic dermatitis.
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ABSTRACT:
SUBMITTER: Izadi N
PROVIDER: S-EPMC8564861 | biostudies-literature | 2018 Jan
REPOSITORIES: biostudies-literature
Publications
Clinical approach to the patient with refractory atopic dermatitis.
Izadi Neema N Leung Donald Y M DYM
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology 20180101 1
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Project description:BackgroundPatient-focused approaches to capturing day-to-day variability in sleep disturbance are needed to properly evaluate the sleep benefits of new treatments. Such approaches rely on patient-reported outcome (PRO) measures validated in the target patient population.MethodsUsing atopic dermatitis (AD) as an example of a disease in which sleep is commonly disturbed, we developed a strategy for measuring sleep disturbance in AD trials. In developing this strategy, we conducted a targeted literature review and held concept elicitation interviews with adolescents and adults with AD. We subsequently identified potentially suitable PRO measures and cognitively debriefed them. Finally, we evaluated their psychometric properties using data from phase 2b (NCT03100344) and phase 3 (NCT03985943 and NCT03989349) clinical trials.ResultsThe literature review confirmed that sleep disturbance is a key impact of AD but failed to identify validated PRO measures for assessing fluctuations in sleep disturbance. Subsequent concept elicitation interviews confirmed the multidimensional nature of sleep disturbance in AD and supported use of a single-item measure to assess overall sleep disturbance severity, complemented by a diary to capture individual components of sleep disturbance. The single-item sleep disturbance numerical rating scale (SD NRS) and multi-item Subject Sleep Diary (SSD)-an AD-adapted version of the Consensus Sleep Diary-were identified as potentially suitable PRO measures. Cognitive debriefing of the SD NRS and SSD demonstrated their content validity and their understandability to patients. Psychometric analyses based on AD trial data showed that the SD NRS is a well-defined, reliable, and fit-for-purpose measure of sleep disturbance in adults with AD. Furthermore, the SD NRS correlated with many SSD sleep parameters, suggesting that most concepts from the SSD can be covered using the SD NRS.ConclusionsUsing these findings, we developed an approach for measuring sleep disturbance in AD trials. Subject to further research, the same approach could also be applied to future trials of other skin diseases where itch causes sleep disturbance.
| S-EPMC11250737 | biostudies-literature
Project description:Atopic dermatitis (AD) is the most common chronic inflammatory skin disease. Genetic predisposition, epidermal barrier disruption, and dysregulation of the immune system are some of the critical components of AD. An impaired skin barrier may be the initial step in the development of the atopic march as well as AD, which leads to further skin inflammation and allergic sensitization. Type 2 cytokines as well as interleukin 17 and interleukin 22 contribute to skin barrier dysfunction and the development of AD. New insights into the pathophysiology of AD have focused on epidermal lipid profiles, neuroimmune interactions, and microbial dysbiosis. Newer therapeutic strategies focus on improving skin barrier function and targeting polarized immune pathways found in AD. Further understanding of AD pathophysiology will allow us to achieve a more precision medicine approach to the prevention and the treatment of AD.
| S-EPMC6399565 | biostudies-literature
Project description:BackgroundAtopic dermatitis (AD) is a chronic inflammatory skin disease that affects children and adults. Poor treatment adherence in AD requires interventions to promote self-management; patient education in chronic diseases is key to self-management. Many international AD management guidelines published to date include a recommendation for educating patients as part of their treatment but there are no formal recommendations on how to deliver this knowledge. MAIN: We performed a scoping review to map the existing literature on patient education practices in AD and to highlight the clinical need for improved patient education in AD. The literature search was performed with the online databases MEDLINE, Embase, Grey Matters, ClinicalTrails.gov and the International Clinical Trials Registry Platform (ICTRP). The search strategy yielded 388 articles. Of the 388 articles screened, 16 studies met the eligibility criteria, and the quantitative data was summarized by narrative synthesis. The majority of studies were randomized controlled trials conducted in Europe, Asia and North America. Since 2002, there have been limited studies evaluating patient education in the treatment of AD. Frequent education methods used included group-based educational programs, educational pamphlets, individual consultations and online resources. Education was most commonly directed at caregivers and their children. Only one study compared the efficacy of different education methods. In all included studies, the heterogenous nature of outcome measures and study design limited the consistency of results. Despite the heterogeneity of studies, patient education was shown to improve quality of life (QoL), disease severity and psychological outcomes in AD patients.ConclusionThis scoping review highlights that patient education is effective in a variety of domains relevant to AD treatment. Further comparative studies and randomized trials with longer-term follow-up are needed to provide validated and consistent patient education recommendations for AD; these may depend on age and population.
| S-EPMC10576377 | biostudies-literature
Project description:BackgroundSevere refractory atopic dermatitis (AD) is a chronic, debilitating condition that is associated with elevated serum immunoglobulin E (IgE) levels. Thymic stromal lymphopoietin (TSLP), thymus and activation-regulated chemokine (TARC) and OX40 ligand (OX40L) are important immunologic factors involved in the pathogenesis of AD. Omalizumab, an anti-IgE antibody indicated for use in allergic asthma, is implicated in regulating allergen presentation by dendritic cells and the T cell response during the effector phases of allergic disease. We investigated if anti-IgE therapy modulates the allergen-specific responses mediated by the TSLP pathway in young patients with severe refractory AD.MethodsThis was a randomized, double-blind, placebo-controlled study of 8 patients between the ages of 4 and 22 years (mean = 11.6 years) with severe refractory AD (clinical trials.gov NCT01678092). Serum IgE ranged from 218 to 1,890 (mean = 1,068 IU/ml). Subjects received omalizumab (n = 4) or placebo (n = 4) every 2-4 weeks over 24 weeks using a regimen extrapolated from the package insert. TSLP, TARC, OX40L and other cytokines involved in AD were measured by using cytometric bead arrays.ResultsAll patients receiving omalizumab had strikingly decreased levels of TSLP, OX40L, TARC (involved in Th2 polarization) and interleukin (IL)-9 compared to placebo. In addition, there was a marked increase in IL-10, a tolerogenic cytokine, in the omalizumab-treated group. Patients on anti-IgE therapy had an improvement in clinical outcomes as measured by the SCORAD system; however, these effects were comparable to improvements in the control group.ConclusionsAnti-IgE therapy with omalizumab decreases levels of cytokines that are involved in Th2 polarization and allergic inflammation, including TSLP, TARC and OX40L.
| S-EPMC4161454 | biostudies-literature
Project description:BackgroundAtopic dermatitis (AD) is a common chronic eczematous skin disease with severe pruritus. Several new therapeutic agents for AD such as dupilumab, an anti-IL-4Rα antibody, have been developed in recent years. We need to predict which agent is the best choice for each patient, but this remains difficult.ObjectiveOur aim was to examine clinical background factors and baseline biomarkers that could predict the achievement of improved clinical outcomes in patients with AD treated with dupilumab.MethodsA multicenter, prospective observational study was conducted on 110 patients with AD. The Eczema Area and Severity Index was used as an objective assessment, and the Patient-Oriented Eczema Measure and Numerical Rating Scale for Pruritus were used as patient-reported outcomes. In addition, some clinical background factors were evaluated.ResultsThe achievement of an absolute Eczema Area and Severity Index of 7 or less was negatively associated with current comorbidity of food allergy and baseline serum lactate dehydrogenase (LDH) levels. There were negative associations between achievement of a Patient-Oriented Eczema Measure score of 7 or less and duration of severe AD and between achievement of an itching Numerical Rating Scale for Pruritus score of 1 or less and current comorbidity of allergic conjunctivitis or baseline serum periostin level. Furthermore, signal detection analysis showed that a baseline serum LDH level less than 328 U/L could potentially be used as a cutoff value for predicting the efficacy of dupilumab.ConclusionBaseline biomarkers such as LDH and periostin and clinical background factors such as current comorbidity of food allergy and a long period of severe disease may be useful indicators when choosing dupilumab for systemic treatment for AD, as they can predict the efficacy of dupilumab.
| S-EPMC11381866 | biostudies-literature
Project description:ObjectiveTo evaluate the effect of text messages with information about atopic dermatitis (AD) on the quality of life (QoL) of children and their caregivers and on the severity of the disease.MethodsResearcher-blinded randomized controlled clinical trial. The experimental group (EG) received messages about AD and the control group (CG) about general health. A total of 56 children under 15 years of age and their caregivers, allocated to the CG and EG, were assessed on admission, after one month, and after four months. Improvement in QoL was measured by the Children's Dermatology Life Quality Index (CDLQI), the Infants' Dermatitis Quality of Life Index (IDQOL), and the Dermatitis Family Impact Questionnaire (DFIQ), and improvement in the severity of AD by the Scoring of Atopic Dermatitis (SCORAD) and the Eczema Area and Severity Index (EASI).ResultsMedian age was of nine years, 33 (58.9 %) were girls. The CG and EG had similar results, except for the higher frequency of mild AD in the CG and moderate/severe AD in the EG-these severity categories were kept grouped together. Regarding mild and moderate/severe AD in the EG, the SCORAD score decreased (p = 0.03 and p < 0.001). The EASI in both groups showed a significant reduction (mild AD: CG: p = 0.01, EG: p = 0.04; moderate/severe AD: CG: p = 0.05, EG: p = 0.02). The QoL of children and caregivers improved only in the EG (p = 0.01). Intergroup analysis showed no differences.ConclusionThe improvement in the severity of AD in both groups suggests the positive effects of educational interventions in general, not only those specific to the disease.
| S-EPMC11763882 | biostudies-literature
Project description:IntroductionThe diagnosis and management of atopic dermatitis (AD) is extensively addressed in detailed clinical guidelines. However, the high heterogeneity regarding presentation and progression and the increasingly broad therapeutic landscape suggest a complex real-world scenario, leading to multiple trajectories of AD patients.MethodsUsing a Delphi methodology for assessing the degree of consensus, we explored the views of a panel of dermatologists regarding the patients' trajectory through the diagnosis (block 1), treatment (block 2), and long-term management (block 3) of AD. Based on a systematic search of the literature, a scientific committee prepared a questionnaire of relevant items that were rated on a 10-point scale (from "totally agree" to "totally disagree") by a panel of dermatologists attending patients with AD in the hospital setting. Consensus was established based on predefined rules.ResultsThe final questionnaire included 58 items and was answered by 17 dermatologists. Overall, consensus was reached on 22 items (37.9%), each of which was a consensus for agreement. The consensus rates in blocks 1, 2, and 3 were 22.7%, 19.0%, and 86%, respectively.ConclusionsOur analysis revealed a remarkable lack of consensus on various aspects of the routine diagnosis and treatment of AD. These findings suggest the presence of unmet needs or limited implementation of guidelines for the management of AD and encourage further research to explore the causes of this low consensus on the management of AD in the real-world setting.
| S-EPMC8484426 | biostudies-literature
Project description:Atopic dermatitis (AD) is a common chronic, pruritic inflammatory skin disease that profoundly impacts patients' quality of life. As the first FDA-approved topical JAK inhibitor, ruxolitinib 1.5% cream represents a novel therapeutic topical agent for the treatment of AD. The objective of this review is to summarize the efficacy and safety of ruxolitinib cream in patients with AD based on the available evidence. Overall, ruxolitinib cream demonstrated high efficacy and a favorable safety profile for treating atopic dermatitis.
| S-EPMC9617518 | biostudies-literature
Project description:Atopic dermatitis (AD) is a chronic and relapsing disease affecting an increasing number of patients. Usually starting in early childhood, AD can be the initial step of the so-called atopic march, i.e. followed by allergic rhinitis and allergic asthma. AD is a paradigmatic genetically complex disease involving gene-gene and gene-environment interactions. Genetic linkage analysis as well as association studies have identified several candidate genes linked to either the epidermal barrier function or to the immune system. Stress, bacterial or viral infections, the exposure to aero- or food-allergens as well as hygienic factors are discussed to aggravate symptoms of AD. Athough generalized Th2-deviated immune response is closely linked to the condition of AD, the skin disease itself is a biphasic inflammation with an initial Th2 phase and while chronic lesions harbour Th0/Th1 cells. Regulatory T cells have been shown to be altered in AD as well as the innate immune system in the skin. The main treatment-goals include the elimination of inflammation and infection, preserving and restoring the barrier function and controlling exacerbating factors. The overall future strategy in AD will be aimed to control skin inflammation by a more proactive management in order to potentially prevent the emergence of sensitization as well as to design customized management based on genetic and pathophysiologic information.
| S-EPMC2883413 | biostudies-literature
Project description:BackgroundThe purpose of this study was to gather information on the current assessment and management of patients with moderate-to-severe AD in routine daily practice.MethodsA cross-sectional two-round Delphi survey with the participation of dermatologists and allergologists throughout Spain was conducted. They completed a 46-item questionnaire, and consensus was defined when responses of ≥80% of participants coincided in the categories of a 5-point Likert scale for that item.ResultsA total of 105 specialists (aged 40-59 years) completed the two rounds. Participants agreed regarding the consideration of AD as a multifaceted disease and the differences in clinical presentation of AD according to the patient's age. It is recommendable to perform a skin biopsy to exclude early stage T-cell cutaneous lymphoma, psoriasis, or dermatitis herpetiformis, among others (99.1%). Also, consensus was reached regarding the use of the SCORAD index to quantify the severity of the disease (86.7%), the use of wet wraps to increase the effect of topical corticosteroids (90.4%), the usefulness of proactive treatment during follow-up (85.6%) and tacrolimus ointment (91.2%) to reduce new flares, and the fact that crisaborole is not the treatment of choice for severe AD (92.4%). AD was not considered a contraindication for immunotherapy in patients with allergic respiratory diseases (92.4%). In patients with severe AD, the use of immune response modifier drugs (97.6%) or phototherapy (92.8%) does not sufficiently cover their treatment needs. Consensus was also obtained regarding the role of the new biologic drugs (93.6%) targeting cytokines involved in the Th2 inflammatory pathway (92.0%) and the potential role of dupilumab as first-line treatment (90.4%) in moderate-to-severe AD patients.ConclusionThis study contributes a reference framework to the care of AD patients. There is no diagnostic test or biomarkers to direct treatment or to assess the severity of the disease, and many therapeutic challenges remain.
| S-EPMC7166259 | biostudies-literature