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  1. Article ; Online: Treatment of atopic dermatitis: Recently approved drugs and advanced clinical development programs.

    Müller, Svenja / Maintz, Laura / Bieber, Thomas

    Allergy

    2024  

    Abstract: Atopic dermatitis (AD) represents the most common skin disease characterized by heterogeneous endophenotypes and a high disease burden. In Europe, six new systemic therapies for AD have been approved: the biologics dupilumab (anti-interleukin-4 receptor ( ...

    Abstract Atopic dermatitis (AD) represents the most common skin disease characterized by heterogeneous endophenotypes and a high disease burden. In Europe, six new systemic therapies for AD have been approved: the biologics dupilumab (anti-interleukin-4 receptor (IL-4R) α in 2017), tralokinumab (anti-IL-13 in 2021), lebrikizumab (anti-IL-13 in 2023), and the oral janus kinase (JAK) inhibitors (JAKi) targeting JAK1/2 (baricitinib in 2020 in the EU) or JAK1 (upadacitinib in 2021 and abrocitinib in 2022). Herein, we give an update on new approvals, long-term safety, and efficacy. Upadacitinib and abrocitinib have the highest short-term efficacy among the approved systemic therapies. In responders, dupilumab and tralokinumab catch up regarding long-term efficacy and incremental clinical benefit within continuous use. Recently, the European Medicines Agency has released recommendations for the use of JAKi in patients at risk (cardiovascular and thromboembolic diseases, malignancies, (former) smoking, and age ≥65 years). Furthermore, we give an overview on emerging therapies currently in Phase III trials. Among the topical therapies, tapinarof (aryl hydrocarbon receptor), ruxolitinib (JAK1/2i), delgocitinib (pan-JAKi), asivatrep (anti-transient receptor potential vanilloid), and phosphodiesterase-4-inhibitors (roflumilast, difamilast) are discussed. Among systemic therapies, current data on cord-blood-derived mesenchymal stem cells, CM310 (anti IL-4Rα), nemolizumab (anti-IL-31RA), anti-OX40/OX40L-antibodies, neurokinin-receptor-1-antagonists, and difelikefalin (κ-opioid-R) are reported.
    Language English
    Publishing date 2024-01-08
    Publishing country Denmark
    Document type Journal Article ; Review
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/all.16009
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  2. Article: From Skin Barrier Dysfunction to Systemic Impact of Atopic Dermatitis: Implications for a Precision Approach in Dermocosmetics and Medicine.

    Maintz, Laura / Bieber, Thomas / Simpson, Helen D / Demessant-Flavigny, Anne-Laure

    Journal of personalized medicine

    2022  Volume 12, Issue 6

    Abstract: Atopic dermatitis (AD) affects up to 20% of children and is considered the starting point of the atopic march with the development of food allergy, asthma, and allergic rhinitis. The heterogeneous phenotype reflects distinct and/or overlapping ... ...

    Abstract Atopic dermatitis (AD) affects up to 20% of children and is considered the starting point of the atopic march with the development of food allergy, asthma, and allergic rhinitis. The heterogeneous phenotype reflects distinct and/or overlapping pathogenetic mechanisms with varying degrees of epidermal barrier disruption, activation of different T cell subsets and dysbiosis of the skin microbiome. Here, we review current evidence suggesting a systemic impact of the cutaneous inflammation in AD together with a higher risk of asthma and other comorbidities, especially in severe and persistent AD. Thus, early therapy of AD to restore the impaired skin barrier, modified microbiome, and target type 2 inflammation, depending on the (endo)phenotype, in a tailored approach is crucial. We discuss what we can learn from the comorbidities and the implications for preventive and therapeutic interventions from precision dermocosmetics to precision medicine. The stratification of AD patients into biomarker-based endotypes for a precision medicine approach offers opportunities for better long-term control of AD with the potential to reduce the systemic impact of a chronic skin inflammation and even prevent or modify the course, not only of AD, but possibly also the comorbidities, depending on the patient's age and disease stage.
    Language English
    Publishing date 2022-05-28
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2662248-8
    ISSN 2075-4426
    ISSN 2075-4426
    DOI 10.3390/jpm12060893
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  3. Article ; Online: Measuring Atopic Dermatitis Disease Severity: The Potential for Electronic Tools to Benefit Clinical Care.

    Maintz, Laura / Bieber, Thomas / Bissonnette, Robert / Jack, Carolyn

    The journal of allergy and clinical immunology. In practice

    2021  Volume 9, Issue 4, Page(s) 1473–1486.e2

    Abstract: Severity of atopic dermatitis (AD) correlates with impact on health-related quality of life (HRQoL), work productivity, and burden on health systems. Tools to measure severity inform regulatory approval, drug access, and value- or measurement-based care. ...

    Abstract Severity of atopic dermatitis (AD) correlates with impact on health-related quality of life (HRQoL), work productivity, and burden on health systems. Tools to measure severity inform regulatory approval, drug access, and value- or measurement-based care. A core set of instruments for measuring AD has been established. Clinician-reported tools are divided broadly into multi-item global estimates or precise calculators that also weigh affected corporeal surfaces. Increasingly, subjective patient-reported outcomes are valued, with the potential to capture vast amounts of health-related data. Patient-reported outcomes can be disease-agnostic, skin-related, or AD-specific, and evaluate global disease, itch severity, long-term control, or overall HRQoL. Patient-reported outcomes are expansive in number; therefore, item banks and adaptive digital user interfaces will be increasingly needed, along with capacity to store and analyze data. Technologies for AD include tools for communication, severity assessment, or data exchange, as well as electronic health records (EHRs). For clinicians, a limited number of applications exist, with relatively poor interoperability with EHRs to date. For patients, a growing number of mobile health (mHealth) applications exhibit variable compliance with international guidelines for self-management. Data privacy and information security governance are key considerations in the development of information technologies for AD. Integrated and streamlined digital operational processes for disease measurements may build capacity for high value and efficient care of patients with AD across the globe.
    MeSH term(s) Dermatitis, Atopic/diagnosis ; Dermatitis, Atopic/epidemiology ; Dermatitis, Atopic/therapy ; Eczema ; Electronics ; Humans ; Quality of Life ; Severity of Illness Index
    Language English
    Publishing date 2021-04-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2843237-X
    ISSN 2213-2201 ; 2213-2198
    ISSN (online) 2213-2201
    ISSN 2213-2198
    DOI 10.1016/j.jaip.2021.02.027
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  4. Article ; Online: Development of a clinical algorithm to predict phenotypic switches between atopic dermatitis and psoriasis (the "Flip-Flop" phenomenon).

    Müller, Svenja / Welchowski, Thomas / Schmid, Matthias / Maintz, Laura / Herrmann, Nadine / Wilsmann-Theis, Dagmar / Royeck, Thorben / Havenith, Regina / Bieber, Thomas

    Allergy

    2023  Volume 79, Issue 1, Page(s) 164–173

    Abstract: Background: Atopic dermatitis (AD) and psoriasis vulgaris (PV) are almost mutually exclusive diseases with different immune polarizations, mechanisms and therapeutic targets. Switches to the other disease ("Flip-Flop" [FF] phenomenon) can occur with or ... ...

    Abstract Background: Atopic dermatitis (AD) and psoriasis vulgaris (PV) are almost mutually exclusive diseases with different immune polarizations, mechanisms and therapeutic targets. Switches to the other disease ("Flip-Flop" [FF] phenomenon) can occur with or without systemic treatment and are often referred to as paradoxical reactions under biological therapy.
    Methods: The objective was to develop a diagnostic algorithm by combining clinical criteria of AD and PV to identify FF patients. The algorithm was prospectively validated in patients enrolled in the CK-CARE registry in Bonn, Germany. Afterward, algorithm refinements were implemented based on machine learning.
    Results: Three hundred adult Caucasian patients were included in the validation study (n = 238 with AD, n = 49 with PV, n = 13 with FF; mean age 41.2 years; n = 161 [53.7%] female). The total FF scores of the PV and AD groups differed significantly from the FF group in the validation data (p < .001). The predictive mean generalized Youden-Index of the initial model was 78.9% [95% confidence interval 72.0%-85.6%] and the accuracy was 89.7%. Disease group-specific sensitivity was 100% (FF), 95.0% (AD), and 61.2% (PV). The specificity was 89.2% (FF), 100% (AD), and 100% (PV), respectively.
    Conclusion: The FF algorithm represents the first validated tool to identify FF patients.
    MeSH term(s) Adult ; Humans ; Female ; Male ; Dermatitis, Atopic/diagnosis ; Psoriasis/diagnosis ; Administration, Cutaneous ; Germany/epidemiology
    Language English
    Publishing date 2023-10-21
    Publishing country Denmark
    Document type Journal Article
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/all.15921
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Immunoglobulin E autoantibodies in atopic dermatitis associate with Type-2 comorbidities and the atopic march.

    Kortekaas Krohn, Inge / Badloe, Fariza Mishaal Saiema / Herrmann, Nadine / Maintz, Laura / De Vriese, Shauni / Ring, Johannes / Bieber, Thomas / Gutermuth, Jan

    Allergy

    2023  Volume 78, Issue 12, Page(s) 3178–3192

    Abstract: Background: Autoreactive immunoglobulin E (IgE) antibodies to self-peptides within the epidermis have been identified in patients with atopic dermatitis (AD). Prevalence, concomitant diseases, patient characteristics, and risk factors of IgE ... ...

    Abstract Background: Autoreactive immunoglobulin E (IgE) antibodies to self-peptides within the epidermis have been identified in patients with atopic dermatitis (AD). Prevalence, concomitant diseases, patient characteristics, and risk factors of IgE autoantibody development remain elusive. We aimed to determine IgE autoantibodies in serum samples (n = 672) from well-characterized patients with AD and controls (1.2-88.9 years).
    Methods: Atopic dermatitis patients were sub-grouped in AD with comorbid Type-2 diseases ("AD + Type 2"; asthma, allergic rhinitis, food allergy, n = 431) or "solely AD" (n = 115). Also, subjects without AD but with Type-2 diseases ("atopic controls," n = 52) and non-atopic "healthy controls" (n = 74) were included. Total proteins from primary human keratinocytes were used for the immunoassay to detect IgE autoantibodies. Values were compared to already known positive and negative serum samples.
    Results: Immunoglobulin E autoantibodies were found in 15.0% (82/546) of all analyzed AD-patients. "AD + Type 2" showed a higher prevalence (16.4%) than "solely AD" (9.6%). "Atopic controls" (9.6%) were comparable with "solely AD" patients, while 2.7% of healthy controls showed IgE autoantibodies. Of those with high levels of IgE autoantibodies, 15 out of 16 were patients with "AD + Type 2". AD patients with IgE autoantibodies were younger than those without. Patients with IgE autoreactivity also displayed higher total serum IgE levels. Factors that affected IgE autoantibody development were as follows: birth between January and June, cesarean-section and diversity of domestic pets.
    Conclusions: Immunoglobulin E autoantibodies in AD seem to associate with the presence of atopic comorbidities and environmental factors. The potential value of IgE autoantibodies as a predictive biomarker for the course of AD, including the atopic march, needs further exploration.
    MeSH term(s) Humans ; Dermatitis, Atopic/diagnosis ; Dermatitis, Atopic/epidemiology ; Autoantibodies ; Immunoglobulin E ; Asthma ; Keratinocytes
    Chemical Substances Autoantibodies ; Immunoglobulin E (37341-29-0)
    Language English
    Publishing date 2023-07-24
    Publishing country Denmark
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/all.15822
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  6. Article ; Online: Serum receptor activator of nuclear factor kappa-Β ligand/osteoprotegerin ratio correlates with severity and suggests fracture's risk in older women with atopic dermatitis.

    Sakai, Takashi / Herrmann, Nadine / Maintz, Laura / Nümm, Tim Joachim / Welchowski, Thomas / Bieber, Thomas

    Allergy

    2021  Volume 76, Issue 10, Page(s) 3220–3223

    MeSH term(s) Aged ; Dermatitis, Atopic/diagnosis ; Dermatitis, Atopic/epidemiology ; Eczema ; Female ; Humans ; Ligands ; NF-kappa B ; Osteoprotegerin ; RANK Ligand
    Chemical Substances Ligands ; NF-kappa B ; Osteoprotegerin ; RANK Ligand
    Language English
    Publishing date 2021-06-15
    Publishing country Denmark
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/all.14971
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  7. Article ; Online: IL‐13, periostin and dipeptidyl‐peptidase‐4 reveal endotype‐phenotype associations in atopic dermatitis

    Maintz, Laura / Welchowski, Thomas / Herrmann, Nadine / Brauer, Juliette / Traidl‐Hoffmann, Claudia / Havenith, Regina / Müller, Svenja / Rhyner, Claudio / Dreher, Anita / Schmid, Matthias / Bieber, Thomas

    Allergy. 2023 June, v. 78, no. 6, p. 1554-1569

    2023  , Page(s) 1554–1569

    Abstract: BACKGROUND: The heterogeneous (endo)phenotypes of atopic dermatitis (AD) require precision medicine. Currently, systemic therapy is recommended to patients with an Eczema Area and Severity Index (EASI) ≥ 16. Previous studies have demonstrated an improved ...

    Institution CK‐CARE study group
    Abstract BACKGROUND: The heterogeneous (endo)phenotypes of atopic dermatitis (AD) require precision medicine. Currently, systemic therapy is recommended to patients with an Eczema Area and Severity Index (EASI) ≥ 16. Previous studies have demonstrated an improved treatment response to the anti‐interleukin (IL)‐13 antibody tralokinumab in AD subgroups with elevated levels of the IL‐13‐related biomarkers dipeptidyl‐peptidase (DPP)‐4 and periostin. METHODS: Herein, 373 AD patients aged ≥12 years were stratified by IL‐13ʰⁱᵍʰ, periostinʰⁱᵍʰ and DPP‐4ʰⁱᵍʰ endotypes using cross‐sectional data from the ProRaD cohort Bonn. “High” was defined as >80th quantile of 47 non‐atopic controls. We analyzed endotype‐phenotype associations using machine‐learning gradient boosting compared to logistic regression. RESULTS: Atopic dermatitis severity and eosinophils correlated with IL‐13 and periostin levels. Correlations of IL‐13 with EASI were stronger in patients with increased (rs = 0.482) than with normal (rs = 0.342) periostin levels. We identified eosinophilia >6% and an EASI range of 5.5–17 dependent on the biomarker combination to be associated with increasing probabilities of biomarkerʰⁱᵍʰ endotypes. Also patients with mild‐to‐low‐moderate severity (EASI < 16) featured increased biomarkers (IL‐13ʰⁱᵍʰ: 41%, periostinʰⁱᵍʰ: 48.4%, DPP‐4ʰⁱᵍʰ: 22.3%). Herthoge sign (adjusted Odds Ratio (aOR) = 1.89, 95% Confidence Interval (CI) [1.14–3.14]) and maternal allergic rhinitis (aOR = 2.79–4.47) increased the probability of an IL‐13ʰⁱᵍʰ‐endotype, “dirty neck” (aOR = 2.83 [1.32–6.07]), orbital darkening (aOR = 2.43 [1.08–5.50]), keratosis pilaris (aOR = 2.21 [1.1–4.42]) and perleche (aOR = 3.44 [1.72–6.86]) of a DPP‐4ʰⁱᵍʰ‐endotype. CONCLUSIONS: A substantial proportion of patients with EASI < 16 featured high biomarker levels suggesting systemic impact of skin inflammation already below the current cut‐off for systemic therapy. Our findings facilitate the identification of patients with distinct endotypes potentially linked to response to IL‐13‐targeted therapy.
    Keywords allergic rhinitis ; antibodies ; artificial intelligence ; atopic dermatitis ; biomarkers ; confidence interval ; eczema ; eosinophilia ; eosinophils ; hyperkeratosis ; inflammation ; interleukin-13 ; odds ratio ; precision medicine ; regression analysis
    Language English
    Dates of publication 2023-06
    Size p. 1554-1569
    Publishing place John Wiley & Sons, Ltd
    Document type Article ; Online
    Note JOURNAL ARTICLE
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/all.15647
    Database NAL-Catalogue (AGRICOLA)

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  8. Article ; Online: Development of a clinical algorithm to predict phenotypic switches between atopic dermatitis and psoriasis (the “Flip‐Flop” phenomenon)

    Müller, Svenja / Welchowski, Thomas / Schmid, Matthias / Maintz, Laura / Herrmann, Nadine / Wilsmann‐Theis, Dagmar / Royeck, Thorben / Havenith, Regina / Bieber, Thomas

    Allergy. 2024 Jan., v. 79, no. 1, p. 164-173

    2024  , Page(s) 164–173

    Abstract: BACKGROUND: Atopic dermatitis (AD) and psoriasis vulgaris (PV) are almost mutually exclusive diseases with different immune polarizations, mechanisms and therapeutic targets. Switches to the other disease (“Flip‐Flop” [FF] phenomenon) can occur with or ... ...

    Abstract BACKGROUND: Atopic dermatitis (AD) and psoriasis vulgaris (PV) are almost mutually exclusive diseases with different immune polarizations, mechanisms and therapeutic targets. Switches to the other disease (“Flip‐Flop” [FF] phenomenon) can occur with or without systemic treatment and are often referred to as paradoxical reactions under biological therapy. METHODS: The objective was to develop a diagnostic algorithm by combining clinical criteria of AD and PV to identify FF patients. The algorithm was prospectively validated in patients enrolled in the CK‐CARE registry in Bonn, Germany. Afterward, algorithm refinements were implemented based on machine learning. RESULTS: Three hundred adult Caucasian patients were included in the validation study (n = 238 with AD, n = 49 with PV, n = 13 with FF; mean age 41.2 years; n = 161 [53.7%] female). The total FF scores of the PV and AD groups differed significantly from the FF group in the validation data (p < .001). The predictive mean generalized Youden‐Index of the initial model was 78.9% [95% confidence interval 72.0%–85.6%] and the accuracy was 89.7%. Disease group‐specific sensitivity was 100% (FF), 95.0% (AD), and 61.2% (PV). The specificity was 89.2% (FF), 100% (AD), and 100% (PV), respectively. CONCLUSION: The FF algorithm represents the first validated tool to identify FF patients.
    Keywords adults ; algorithms ; atopic dermatitis ; confidence interval ; females ; models ; phenotype ; psoriasis ; therapeutics ; Germany
    Language English
    Dates of publication 2024-01
    Size p. 164-173
    Publishing place John Wiley & Sons, Ltd
    Document type Article ; Online
    Note JOURNAL ARTICLE
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/all.15921
    Database NAL-Catalogue (AGRICOLA)

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  9. Article ; Online: From Skin Barrier Dysfunction to Systemic Impact of Atopic Dermatitis

    Laura Maintz / Thomas Bieber / Helen D. Simpson / Anne-Laure Demessant-Flavigny

    Journal of Personalized Medicine, Vol 12, Iss 893, p

    Implications for a Precision Approach in Dermocosmetics and Medicine

    2022  Volume 893

    Abstract: Atopic dermatitis (AD) affects up to 20% of children and is considered the starting point of the atopic march with the development of food allergy, asthma, and allergic rhinitis. The heterogeneous phenotype reflects distinct and/or overlapping ... ...

    Abstract Atopic dermatitis (AD) affects up to 20% of children and is considered the starting point of the atopic march with the development of food allergy, asthma, and allergic rhinitis. The heterogeneous phenotype reflects distinct and/or overlapping pathogenetic mechanisms with varying degrees of epidermal barrier disruption, activation of different T cell subsets and dysbiosis of the skin microbiome. Here, we review current evidence suggesting a systemic impact of the cutaneous inflammation in AD together with a higher risk of asthma and other comorbidities, especially in severe and persistent AD. Thus, early therapy of AD to restore the impaired skin barrier, modified microbiome, and target type 2 inflammation, depending on the (endo)phenotype, in a tailored approach is crucial. We discuss what we can learn from the comorbidities and the implications for preventive and therapeutic interventions from precision dermocosmetics to precision medicine. The stratification of AD patients into biomarker-based endotypes for a precision medicine approach offers opportunities for better long-term control of AD with the potential to reduce the systemic impact of a chronic skin inflammation and even prevent or modify the course, not only of AD, but possibly also the comorbidities, depending on the patient’s age and disease stage.
    Keywords asthma ; atopic dermatitis ; atopic march ; biologic therapies ; comorbidities ; dermocosmetics ; Medicine ; R
    Subject code 610
    Language English
    Publishing date 2022-05-01T00:00:00Z
    Publisher MDPI AG
    Document type Article ; Online
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  10. Article ; Online: IL-13, periostin and dipeptidyl-peptidase-4 reveal endotype-phenotype associations in atopic dermatitis.

    Maintz, Laura / Welchowski, Thomas / Herrmann, Nadine / Brauer, Juliette / Traidl-Hoffmann, Claudia / Havenith, Regina / Müller, Svenja / Rhyner, Claudio / Dreher, Anita / Schmid, Matthias / Bieber, Thomas

    Allergy

    2023  

    Abstract: Background: The heterogeneous (endo)phenotypes of atopic dermatitis (AD) require precision medicine. Currently, systemic therapy is recommended to patients with an Eczema Area and Severity Index (EASI)≥16. Previous studies have demonstrated an improved ... ...

    Abstract Background: The heterogeneous (endo)phenotypes of atopic dermatitis (AD) require precision medicine. Currently, systemic therapy is recommended to patients with an Eczema Area and Severity Index (EASI)≥16. Previous studies have demonstrated an improved treatment response to the anti-interleukin (IL)-13 antibody tralokinumab in AD subgroups with elevated levels of the IL-13-related biomarkers dipeptidyl-peptidase (DPP)-4 and periostin.
    Methods: Herein, 373 AD patients aged≥12 years were stratified by IL-13
    Results: AD severity and eosinophils correlated with IL-13 and periostin levels. Correlations of IL-13 with EASI were stronger in patients with increased (rs=0.482) than with normal (rs=0.342) periostin levels. We identified eosinophilia>6% and an EASI range of 5.5-17 dependent on the biomarker combination to be associated with increasing probabilities of biomarker
    Conclusions: A substantial proportion of patients with EASI<16 featured high biomarker levels suggesting systemic impact of skin inflammation already below the current cut-off for systemic therapy. Our findings facilitate the identification of patients with distinct endotypes potentially linked to response to IL-13-targeted therapy.
    Language English
    Publishing date 2023-01-17
    Publishing country Denmark
    Document type Journal Article
    ZDB-ID 391933-x
    ISSN 1398-9995 ; 0105-4538
    ISSN (online) 1398-9995
    ISSN 0105-4538
    DOI 10.1111/all.15647
    Database MEDical Literature Analysis and Retrieval System OnLINE

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