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Journal ArticleDOI

The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association

01 Jan 2017-Journal of Investigative Dermatology (Elsevier)-Vol. 137, Iss: 1, pp 26-30
TL;DR: To assess the patient-level and societal burden of atopic dermatitis, the literature related to quality of life, social, economic, academic, and occupational impacts was comprehensively reviewed.
About: This article is published in Journal of Investigative Dermatology.The article was published on 2017-01-01 and is currently open access. It has received 417 citations till now. The article focuses on the topics: Atopic dermatitis & Quality of life (healthcare).
Citations
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Journal ArticleDOI
TL;DR: Dupilumab significantly improved clinical signs and symptoms of AD, was well tolerated, and progressively shifted the lesional transcriptome toward a nonlesional phenotype, as well as suppressing cellular/molecular cutaneous markers of inflammation and systemic measures of type 2 inflammation.
Abstract: Background Dupilumab is an IL-4 receptor α mAb inhibiting signaling of IL-4 and IL-13, key drivers of type 2–driven inflammation, as demonstrated by its efficacy in patients with atopic/allergic diseases. Objective This placebo-controlled, double-blind trial (NCT01979016) evaluated the efficacy, safety, and effects of dupilumab on molecular/cellular lesional and nonlesional skin phenotypes and systemic type 2 biomarkers of patients with moderate-to-severe atopic dermatitis (AD). Methods Skin biopsy specimens and blood were evaluated from 54 patients randomized 1:1 to weekly subcutaneous doses of 200 mg of dupilumab or placebo for 16 weeks. Results Dupilumab (vs placebo) significantly improved clinical signs and symptoms of AD, was well tolerated, and progressively shifted the lesional transcriptome toward a nonlesional phenotype (weeks 4–16). Mean improvements in a meta-analysis–derived AD transcriptome (genes differentially expressed between lesional and nonlesional skin) were 68.8% and 110.8% with dupilumab and −10.5% and 55.0% with placebo (weeks 4 and 16, respectively; P Conclusion Dupilumab-mediated inhibition of IL-4/IL-13 signaling through IL-4 receptor α blockade significantly and progressively improved disease activity, suppressed cellular/molecular cutaneous markers of inflammation and systemic measures of type 2 inflammation, and reversed AD-associated epidermal abnormalities.

368 citations

Journal ArticleDOI
TL;DR: Dupilumab, a human monoclonal antibody that simultaneously inhibits signaling of IL-4 and IL-13, has demonstrated significant clinical efficacy in AD, asthma, and CSwNP, suggesting that there is a common underlying pathogenic pathway, and that IL- 4 and IL -13 cytokines are central to regulating the pathogenesis of these atopic diseases.
Abstract: Introduction: Allergy results from an aberrant Type 2 inflammatory response, triggered by a wide range of environmental antigens (allergens) that lead to various immune responses, culminating in the production of immunoglobulin E (IgE). Two key cytokines, interleukin (IL)-4 and IL-13, are critical to the induction and perpetuation of the Type 2 response, and have been implicated in multiple atopic diseases.Area covered: This review summarizes recent milestone developments that have elucidated components of the pathogenesis of atopic diseases such as atopic dermatitis (AD), asthma, and chronic sinusitis with nasal polyposis (CSwNP).Expert commentary: Several therapeutic agents that selectively target potentiators of the Type 2 pathway have shown efficacy in one or more of these atopic diseases, but few agents have proven to be broadly applicable across all three atopic diseases. Dupilumab, a human monoclonal antibody that simultaneously inhibits signaling of IL-4 and IL-13, has demonstrated signifi...

277 citations


Cites background from "The Burden of Atopic Dermatitis: Su..."

  • ...is common in adults, occurring as a life-long disease or with onset in adulthood, afflicting almost 7% of the US adult population [61]....

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Journal ArticleDOI
TL;DR: This phase 2b, placebo-controlled, randomized clinical trial evaluates the efficacy and safety of lebrikizumab, a novel, high-affinity, monoclonal antibody targeting interleukin (IL)–13 that selectively prevents formation of the IL-13Rα1/IL-4Rα heterodimer receptor signaling complex, in adults with moderate to severe atopic dermatitis.
Abstract: Importance Interleukin 13 (IL-13) is a central pathogenic mediator driving multiple features of atopic dermatitis (AD) pathophysiology. Objective To evaluate the efficacy and safety of lebrikizumab, a novel, high-affinity, monoclonal antibody targeting IL-13 that selectively prevents formation of the IL-13Rα1/IL-4Rα heterodimer receptor signaling complex, in adults with moderate to severe AD. Design, Setting, and Participants A phase 2b, double-blind, placebo-controlled, dose-ranging randomized clinical trial of lebrikizumab injections every 4 weeks or every 2 weeks was conducted from January 23, 2018, to May 23, 2019, at 57 US centers. Participants were adults 18 years or older with moderate to severe AD. Interventions Patients were randomized 2:3:3:3 to placebo every 2 weeks or to subcutaneous injections of lebrikizumab at the following doses: 125 mg every 4 weeks (250-mg loading dose [LD]), 250 mg every 4 weeks (500-mg LD), or 250 mg every 2 weeks (500-mg LD at baseline and week 2). Main Outcomes and Measures The primary end point was percentage change in the Eczema Area and Severity Index (EASI) (baseline to week 16). Secondary end points for week 16 included proportion of patients achieving Investigator’s Global Assessment score of 0 or 1 (IGA 0/1); EASI improvement of at least 50%, 75%, or 90% from baseline; percentage change in the pruritus numeric rating scale (NRS) score; and pruritus NRS score improvement of at least 4 points. Safety assessments included treatment-emergent adverse events. Results A total of 280 patients (mean [SD] age, 39.3 [17.5] years; 166 [59.3%] female) were randomized to placebo (n = 52) or to lebrikizumab at doses of 125 mg every 4 weeks (n = 73), 250 mg every 4 weeks (n = 80), or 250 mg every 2 weeks (n = 75). Compared with placebo (EASI least squares mean [SD] percentage change, −41.1% [56.5%]), lebrikizumab groups showed dose-dependent, statistically significant improvement in the primary end point vs placebo at week 16: 125 mg every 4 weeks (−62.3% [37.3%],P = .02), 250 mg every 4 weeks (−69.2% [38.3%],P = .002), and 250 mg every 2 weeks (−72.1% [37.2%],P Conclusions and Relevance During 16 weeks of treatment, lebrikizumab provided rapid, dose-dependent efficacy across a broad range of clinical manifestations in adult patients with moderate to severe AD and demonstrated a favorable safety profile. These data support the central role of IL-13 in AD pathophysiology. If these findings replicate in phase 3 studies, lebrikizumab may meaningfully advance the standard of care for moderate to severe AD. Trial Registration ClinicalTrials.gov Identifier:NCT03443024

204 citations

Journal ArticleDOI
TL;DR: Comparing biomarkers with individual responses to experimental agents will help to determine subphenotypes within AD that predict prognosis and treatment responses, and most agents are in phase 2 clinical trials.
Abstract: Until the past year, our therapeutic armamentarium for treating atopic dermatitis (AD) was still primarily topical corticosteroids and, for more severe disease, systemic immunosuppressants. The pipeline of more targeted topical and systemic therapies is expanding based on our growing understanding of the mechanism for AD and is particularly focused on suppressing the skewed immune activation. Most agents are in phase 2 clinical trials. Crisaborole, a topical phosphodiesterase 4 (PDE4) inhibitor, became available in late 2016 in the United States for mild-to-moderate AD, with other PDE4 inhibitors, an agonist of the aryl hydrocarbon receptor, Janus kinase inhibitors, and commensal organisms also in trials for topical application. The first highly effective mAb for AD, dupilumab, targets the IL-4/IL-13 receptor and was approved in early 2017 in the United States for moderate-to-severe adult AD. Other biologics similarly inhibit TH2 cytokines (thymic stromal lymphopoietin, IL-4, IL-5, IL-13, and the itch-specific cytokine IL-31 and their receptors) or TH22/TH17 cytokines, levels of which are increased in lesional skin. Orally administered small-molecule inhibitors that suppress inflammation (targeting chemoattractant receptor–homologous molecules expressed on TH2 lymphocytes, PDE4, the histamine 4 receptor, and Janus kinase) or specifically itching (eg, NK1R inhibitors) are also being studied. Comparing biomarkers with individual responses to experimental agents will help to determine subphenotypes within AD that predict prognosis and treatment responses.

165 citations

References
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Journal ArticleDOI
TL;DR: Prevalence ranged from 8.7 to 18.1% between states and districts, with the highest prevalence reported in many of the East Coast states, as well as in Nevada, Utah, and Idaho.

636 citations


"The Burden of Atopic Dermatitis: Su..." refers background or methods in this paper

  • ...2% of US children and adults, respectively (Shaw et al., 2011; Silverberg et al., 2015)....

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  • ...The AD prevalence estimate used (15.2 million, roughly 5% of the US population in 2004), is lower than other population-based estimates of the US prevalence of AD in children (10.7% in 2003) (Shaw et al., 2011) and adults (7.2% in 2012) (Silverberg et al., 2015)....

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  • ...It is prevalent in approximately 10.7% and 7.2% of US children and adults, respectively (Shaw et al., 2011; Silverberg et al., 2015)....

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Journal ArticleDOI
TL;DR: In this paper, the authors estimate the prevalence, economic burden, and impact on quality of life for 22 leading categories of skin disease in the United States and conclude that skin disease is one of the top 15 groups of medical conditions for which prevalence and health care spending increased the most between 1987 and 2000.
Abstract: Skin disease is one of the top 15 groups of medical conditions for which prevalence and health care spending increased the most between 1987 and 2000, with approximately 1 of 3 people in the United States with a skin disease at any given time. Even so, a national data profile on skin disease has not been conducted since the late 1970s. This study closes the gap by estimating the prevalence, economic burden, and impact on quality of life for 22 leading categories of skin disease. The estimated annual cost of skin disease in 2004 was $39.3 billion, including $29.1 billion in direct medical costs (costs of health services and products) and $10.2 billion in lost productivity costs (defined as costs related to consumption of medical care, costs associated with impaired ability to work, and lost future earning potential because of premature death). Based on a methodology of willingness to pay for symptom relief, the additional economic burden of skin disease on quality of life amounted to an estimated $56.2 billion. Including the economic burden on quality of life, the total economic burden of skin disease to the US public in 2004 was approximately $96 billion.

589 citations

Journal ArticleDOI
TL;DR: This work focuses on the use of HRQL measures, which permit comparison between different diseases and also the normal population, to better understand the effects of chronic disease on parent and child relationships.
Abstract: Summary Background Chronic disease can have physical and psychological effects which affect social functioning. These effects can be better understood from the perspective of parent and child by the use of health-related quality of life (HRQL) measures. Various HRQL measures are now available, of which generic health measures have been the most widely used. These permit comparison between different diseases and also the normal population. Objectives To cross-validate a new generic HRQL proxy measure for children, the Children's Life Quality Index© (CLQI), with an established speciality-specific dermatological questionnaire, the Children's Dermatology Life Quality Index© (CDLQI), in a group of children with chronic skin diseases. The impairment of HRQL in the same group of children with skin disease was then compared with that associated with other common chronic childhood diseases using the CLQI. Methods The CDLQI was completed by 379 children aged 5–16 years with skin disease of more than 6 months’ duration. Their parents (n = 379) and parents of 161 children aged 5–16 years with other chronic diseases were also asked to complete a proxy measure, the CLQI. Results Using linear regression analysis, the CLQI and the CDLQI scores showed a strong linear association (rs = 0·72, P < 0·001) and on a Bland–Altman plot, reasonably good agreement (expressing scores out of 100, the 95% limits of agreement were from −25·5/100 to 26·7/100). In the child's opinion psoriasis and atopic dermatitis (AD) caused the greatest impairment (CDLQI scores of 30·6% and 30·5%), followed by urticaria (20%) and acne (18%). Using the generic CLQI (scored 0–36), from the parental perspective the highest score was for AD (33%), followed by urticaria (28%), psoriasis (27%) and alopecia (19%). Comparing this with children with other chronic diseases, those with cerebral palsy had the highest score (38%), followed in descending order by those with generalized AD (33%), renal disease (33%), cystic fibrosis (32%), urticaria (28%), asthma (28%) and psoriasis (27%). Diseases such as epilepsy (24%) and enuresis (24%) scored higher than diabetes (19%), localized eczema (19%), alopecia (19%) and acne (16%). Conclusions Using the CLQI we have shown that HRQL impairment in children with chronic skin disease is at least equal to that experienced by children with many other chronic diseases of childhood, with AD and psoriasis having the greatest impact on HRQL among chronic skin disorders and only cerebral palsy scoring higher than AD. Cross-validation of the CLQI with the CDLQI in the group of children with skin disease demonstrates a strong linear association and good agreement between the two.

468 citations

Journal ArticleDOI
TL;DR: The comprehensive conceptual framework summarizes the ways in which atopic dermatitis affects the quality of life in young American children and forms the basis from which quality-of-life instruments can be developed.
Abstract: Objective. The psychologic, physical, and social impact of atopic dermatitis is complex and varies among children of different ages, and the effects of atopic dermatitis on the quality of life of very young American children and their families are not well understood. This study was conducted to document these effects of atopic dermatitis on young children and their families. Methods. Directed focus sessions were performed with parents of 26 young children with atopic dermatitis and 6 expert clinicians. Specific mentions of the ways in which atopic dermatitis affected the children and parents were reviewed, rank ordered, and categorized according to similarity in content. The categories were examined to determine the domains represented, and the domains were used to compose a conceptual framework of all of the ways that atopic dermatitis affects children and their families. Results. Parents and experts mentioned a total of 181 specific quality-of-life effects. A conceptual framework, developed from the 181 effects, contains the domains of physical health, emotional health, physical functioning, and social functioning; each domain includes effects on both the child and the parents. Conclusions. Atopic dermatitis greatly affects the quality of life of afflicted children and their families. The comprehensive conceptual framework summarizes the ways in which atopic dermatitis affects the quality of life in young American children. This conceptual framework forms the basis from which quality-of-life instruments can be developed.

280 citations


"The Burden of Atopic Dermatitis: Su..." refers background in this paper

  • ...The time required to care for a child with AD is burdensome for families (Chamlin et al., 2004)....

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  • ...Over half of parents interviewed in the study by Chamlin et al. (2004) stated that adults and other children avoided interacting with their children with AD....

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  • ...Chamlin et al. (2004) interviewed the parents of 26 children with AD to determine how AD affects QoL for these young patients....

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Journal ArticleDOI
TL;DR: The burden of illness associated with this condition has not been well characterized and the quality of life for patients with atopic dermatitis is still poorly characterized.
Abstract: Background Although atopic dermatitis is a chronic skin disease that can have a major impact on a patient’s life, the burden of illness associated with this condition has not been well characterized. Objective To determine the health-related quality of life (HRQL) of patients with atopic dermatitis by disease severity and to compare it with that of the general public and of patients suffering from other chronic illnesses or skin disorders. Methods Two hundred and thirty-nine atopic dermatitis patients aged 4–70 years completed the Medical Outcomes Study Short Form-36 Health Survey (SF-36) and the Dermatology Life Quality Index (DLQI) or the Children’s Dermatology Life Quality Index. These HRQL scores were compared by self-reported patient disease severity ratings. Health-related quality of life scores were compared with those of the general population and those of patients with other chronic conditions (clinical depression, hypertension, type 2 diabetes) or skin disease (psoriasis). Dermatology Life Quality Index scores were also compared with those of other skin diseases (such as psoriasis, Darier’s disease, and Hailey-Hailey disease). Results Patients with atopic dermatitis had inferior scores on the SF-36 vitality, social functioning, and mental health subscales compared with individuals in the general population. In seven of eight subscales, individuals reporting more severe disease had inferior DLQI and SF-36 scores. Patients with atopic dermatitis had inferior mental health scores compared with those with diabetes or hypertension, and inferior social functioning scores compared with patients with hypertension. When compared with a psoriasis cohort, patients with atopic dermatitis had inferior scores in the role-physical, vitality, social functioning, role-emotional, and mental health SF-36 domains. Patients with atopic dermatitis had similar DLQI scores to patients with other chronic dermatologic diseases. Conclusions These results demonstrate that atopic dermatitis has an impact on HRQL, particularly in social functioning and psychological wellbeing. Patient-assessed severity of atopic dermatitis correlates with HRQL decrements, indicating greater HRQL impact with greater disease severity. Atopic dermatitis has as large an impact on HRQL as several chronic conditions and other dermatologic conditions.

259 citations


"The Burden of Atopic Dermatitis: Su..." refers result in this paper

  • ...(2002) used the Short Form (SF)-36 Health Survey, a generic health status measure, to assess QoL among 107 AD patients and compared their results with previously published SF-36 scores for the general population and other medical conditions (Kiebert et al., 2002)....

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  • ...Kiebert et al. (2002) used the Short Form (SF)-36 Health Survey, a generic health status measure, to assess QoL among 107 AD patients and compared their results with previously published SF-36 scores for the general population and other medical conditions (Kiebert et al., 2002)....

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