Trial reportInternational archives of allergy and immunology2013
Immunologic effects of omalizumab in children with severe refractory atopic dermatitis: a randomized, placebo-controlled clinical trial.
Trial report in International archives of allergy and immunology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01678092 (Phase 1, Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis), which is not on this map. Cited by 52 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 1, Single Center Study Using Omalizumab in Subjects With Atopic Dermatitis
Who cites it
52 citing papers in PubMed, 3 syntheses or guidelines pooled it, 149 citations in OpenAlex.
- Emerging treatments for dermatologic diseases in infants, children, and adolescents: a systematic review of clinical trials on biologics and small molecule inhibitors.Inflammopharmacology · 2025Pooled it
- Efficacy and Safety of Omalizumab for the Treatment of Severe or Poorly Controlled Allergic Diseases in Children: A Systematic Review and Meta-Analysis.Frontiers in pediatrics · 2022Pooled it
- Systemic treatments for eczema: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Monoclonal Antibodies in Pediatric Atopic Dermatitis; Efficacy and Safety.Current therapeutic research, clinical and experimental · 2026Review
- Pathobiology of atopic dermatitis and association with disease severity after acute oral steroid treatment.The journal of allergy and clinical immunology. Global · 2026Article
- Exploring the impact of IL-2 cytokine family on skin barrier function: pathophysiology and therapeutic strategies.Molecular biology reports · 2026Review
- Patient Stratification for Serum LDH Levels Reveals Distinct CLAInternational journal of molecular sciences · 2025Article
- Comparative Real-World Analysis of Baseline Demographic Characteristics and Comorbidities in Atopic Dermatitis Patients Initiating Biologics Versus JAK Inhibitors.Journal of clinical medicine · 2025Article
- Comparative real-world effectiveness and safety of biologics and JAK inhibitors in atopic dermatitis: short- and medium-to-long-term analysis from a regional healthcare network in southern Spain.Frontiers in medicine · 2025Article
- Anti-OX40 Biological Therapies in the Treatment of Atopic Dermatitis: A Comprehensive Review.Journal of clinical medicine · 2024Review
- The Efficacy and Effectiveness of the Biological Treatment of Pruritus in the Course of Atopic Dermatitis.Journal of clinical medicine · 2024Review
- Management of Atopy with Dupilumab and Omalizumab in CADINS Disease.Journal of clinical immunology · 2024Article
- Biologics and oral small-molecule inhibitors for treatment of pediatric atopic dermatitis: Opportunities and challenges.Pediatric investigation · 2023Review
- Vernal keratoconjunctivitis: Current immunological and clinical evidence and the potential role of omalizumab.The World Allergy Organization journal · 2023Review
- Clinical trials of antibody drugs in the treatments of atopic dermatitis.Frontiers in medicine · 2023Review
- Recent insights into the management of treatment-resistant pediatric atopic dermatitis.International journal of women's dermatology · 2022Review
- An Overview of Off-Label Use of Humanized Monoclonal Antibodies in Paediatrics.Medicina (Kaunas, Lithuania) · 2022Review
- Regulation of Trafficking and Signaling of the High Affinity IgE Receptor by FcεRIβ and the Potential Impact of FcεRIβ Splicing in Allergic Inflammation.International journal of molecular sciences · 2022Review
- Update on the Pathogenesis and Therapy of Atopic Dermatitis.Clinical reviews in allergy & immunology · 2021Review
- Treatments for Childhood Atopic Dermatitis: an Update on Emerging Therapies.Clinical reviews in allergy & immunology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.