Biomarker-driven drug development for allergic diseases and asthma: An FDA public workshop

Rabin RL, Altman MC, Arshad SH et al. J Allergy Clin Immunol. 2025 Jun;155(6):1753-1766. doi: 10.1016/j.jaci.2025.03.014. 

Workshop summary

Core outcome measures for severe adult and pediatric asthma. 

The US Food and Drug Administration (FDA) hosted a workshop on February 22, 2024, to discuss the status of biomarkers in drug development for allergic asthma and food allergy. The workshop provided a forum for open discussion among regulators, academicians, National Institutes of Health staff and industry to inform stakeholders of the requirements for the FDA to adopt a biomarker as a surrogate end point for a clinical trial, and to inform FDA of the status of various biomarkers in development.

Omalizumab in pediatric chronic spontaneous urticaria: A systematic review and meta-analysis of efficacy and safety

Alomari O, Ozceker D, Mokresh ME, et al. Pediatr Allergy Immunol. 2025; 36:e70132. doi:10.1111/pai.70132

Abstract

Chronic spontaneous urticaria significantly impairs quality of life in children, with limited treatment options beyond antihistamines. Omalizumab, an anti-IgE antibody, has shown promise in adults but data on its use in children, especially those under 12, are scarce. This systematic review and meta-analysis aim to evaluate the efficacy and safety of omalizumab in pediatric chronic spontaneous urticaria, providing insights to inform clinical practice and future guidelines. PubMed, Scopus, Embase, Cochrane, and Web of Science databases have been searched for relevant studies. The “R” software has been utilized to analyze the response and relapse rates, changes in urticaria scores, and adverse event rates. Subgroup analyses were also done based on response rate. The assessment of heterogeneity utilized the I2 and chi-squared tests, applying the random effect model.

UAS7 score reduction following omalizumab treatment in pediatric chronic urticaria

This systematic review included 36 studies met the inclusion criteria. The pooled response rate for omalizumab was 88.0% (95% CI: 80.7%–95.2%; I2 = 61.0%; p = .001), with a complete response rate of 51.0% (95% CI: 32.7%–69.2%; I2 = 90.0%; p < .001). Good or well-controlled response rates were 50.5% (95% CI: 33.9%–67.1%; I2 = 54.2%; p = .068), while poor or partial responses were 20.1% (95% CI: 14.3%–27.3%; I2 = 0.0%; p = .787).

Subclinical inflammation precedes atopic dermatitis relapses

Al B, Holzscheck N, Traidl S et al. J Allergy Clin Immunol. 2025 Jun 23:S0091-6749(25)00686-4. doi: 10.1016/j.jaci.2025.03.033.

Abstract

Background
Atopic dermatitis (AD), a widespread inflammatory skin disease, is characterized by disease recurrence, even after successful treatment. Past clinical research has mainly focused on understanding the active disease state as opposed to what drives and triggers AD relapses in the first place.

Objective
To elucidate the unknown molecular mechanisms behind AD relapses.

Methods
An observational clinical study with patients in remission was conducted, comparing biopsies from skin that would relapse within the next weeks with skin that stayed in remission using single-cell-RNA sequencing and immunohistochemistry analyses.

Results
Signs of subclinical inflammation were present in the clinically healthy appearing pre-relapse state.

Estimated 2023-2024 COVID-19 Vaccine Effectiveness in Adults

Link-Gelles R, Rowley EAK, Irving SA, et al.. JAMA Netw Open - Published Online: June 25, 2025;8;(6):e2517402. doi:10.1001/jamanetworkopen.2025.17402

Key Points

Question  What is the vaccine effectiveness (VE) of 2023-2024 COVID-19 vaccines against medically attended COVID-19, including during Omicron XBB and JN.1 sublineage predominance?

Findings  This test-negative case-control study included 345 955 emergency department and urgent care encounters and 111 931 hospitalizations among adults with COVID-19–like illness. During 7 to 299 days after 2023-2024 COVID-19 vaccination, VE was 29% against COVID-19–associated emergency department and urgent care encounters, 30% against COVID-19–associated hospitalization, and 48% against COVID-19–associated critical illness, with VE being the highest 7 to 59 days after vaccination and waning against all outcomes.

Clinical significance of very high IgE levels (≥1000 IU/mL): Population-based study of 118,211 adults

Nemet, Shay et al.
Journal of Allergy and Clinical Immunology: Global, Volume 4, Issue 2, 100403

Abstract

Background

Very high serum IgE (≥1000 IU/mL) is reported in atopic disorders. However, data on its significance in nonallergic disorders are limited.

Objective

We aimed to analyze the diagnostic value of very high IgE in adults.

Methods

A retrospective nationwide study was conducted using the electronic database of Clalit Health Services, covering adults (≥18 years) treated between 2002 and 2022. Subjects with IgE ≥ 1000 IU/mL were compared to the controls with IgE < 100 IU/mL across 3 age groups (18-30, 31-64, and ≥65 years).

Phenotypes of Atopic Dermatitis and Development of Allergic Diseases

Sitarik AR, Eapen AA, Biagini JM, et al.  JAMA Netw Open. 2025;8(6):e2515094. doi:10.1001/jamanetworkopen.2025.15094

Key Points

Question  Is the phenotypic expression of atopic dermatitis (AD) associated with the development of other allergic diseases, and what factors are associated with each phenotype?

Findings  This cohort study of 5314 children from 12 US birth cohorts found that AD in children was common and identified 5 distinct AD phenotypes with different associations with comorbidities. Phenotypes with early AD expression were associated with food allergy, phenotypes with later AD expression with allergic rhinitis, and any AD phenotype with asthma.

A real-life multicenter experience for the post-pandemic management of hypersensitivity reactions to Covid-19 vaccines

Alessandra Arcolaci, Lucia Guidolin, Elisa Olivieriet al. Vaccine Volume 61 2025,127337, https://doi.org/10.1016/j.vaccine.2025.127337.

Abstract

The management of patients with immediate hypersensitivity reactions (IHSR) to COVID-19 vaccines and their components, polyethylene glycol (PEG) 2000 and polisorbate 80 (PS80), has evolved since the beginning of the vaccination campaign. Despite the end of the pandemics, ensuring safe access to COVID-19 vaccination remains critical, especially for individuals with underlying health conditions.

In this retrospective study, we evaluated 333 patients who underwent a standardized allergy work-up, including skin testing (ST) with vaccine components, to assess their eligibility for COVID-19 vaccination. 155 patients had a history of IHSRs to PEG-containing drugs, and 178 reported a IHSR following a prior vaccine dose.

Cow milk allergy: Its clinical aspects, mechanisms, and innovative mitigation strategies beyond enzymatic hydrolysis

Min He, Jun Hu, Jiaxin Deng et al. Journal of Functional Foods, Volume 130, 2025, 106933. 

Highlights

• The current understanding of cow milk allergy is presented.

• The role of enzymatic hydrolysis against allergenicity and its limitations are described.

• More effective innovative strategies that can degrade cow milk allergens are discussed.

Abstract: 

Graphical abstract

Cow milk allergy (CMA) is one of the most common food allergies. Traditional methods for reducing milk allergenicity, such as enzymatic hydrolysis, have limitations, including incomplete allergen degradation and the potential for residual allergenicity. This review aims to provide the current understanding of CMA, including its risk factors, allergen profile, immune mechanisms, and management strategies. It then examines the role of enzymatic hydrolysis in mitigating allergenicity, its applications, and its inherent limitations.

Exploring the Association Between Vitamin D and IL-10 in Allergic Parthenium Contact Dermatitis Patients

Xavier A, Selvarajan S, Das S, et al. (June 07, 2025) Cureus 17(6): e85515. doi:10.7759/cureus.85515

Abstract

Introduction

The imbalance between pro- and anti-inflammatory mediators was suggested to be a contributory factor to the manifestations of allergic parthenium dermatitis. Inadequate circulating vitamin D and IL-10 levels can significantly influence the course of this allergic dermatitis.

Objective

The objective was to study the association between circulating IL-10 levels and vitamin D status in patients with parthenium dermatitis.

Materials and methods

Patients attending the dermatitis clinic were screened for eligibility, and 88 individuals were recruited.

Prevalence, Change and Burden of Systemic Corticosteroid Use in Type 2 Inflammation Associated Diseases Over 25 Years – A Nationwide Danish Study

Håkansson KEJ, Skov IR, Andersen SAW et al. J Asthma Allergy. 2025;18:967-981

https://doi.org/10.2147/JAA.S525508

Background: Systemic corticosteroid use in type 2 inflammation-associated diseases including asthma, atopic dermatitis, allergic rhinitis, and chronic rhinosinusitis has been associated with adverse outcomes, and corticosteroid-sparing treatments are available.

Objective: Assess temporal changes in systemic corticosteroid use and the impact of type 2 inflammation multimorbidity (eg multiple concurrent type 2 inflammation-associated diseases) and specialist assessment on systemic corticosteroid exposure.
Methods: Using nationwide databases, all Danish adults with asthma, atopic dermatitis, allergic rhinitis, or chronic rhinosinusitis, based on hospital diagnoses or redeemed prescriptions between 1997 and 2021 were included in an open, serial cross-sectional cohort.

Changes of (A) prevalence of systemic corticosteroid (SCS) use and
(B) absolute number of systemic corticosteroid users in a cohort of
1,616,609 Danish adults with monomorbid type 2
inflammation-associated disease

Results: Over 25 years, a total of 2,151,209 Danish adults were included. Of those with a single diagnosis (type 2 inflammation monomorbidity),13.9% had asthma, 19.2% allergic rhinitis, 52.9% atopic dermatitis, and 14.0% chronic rhinosinusitis. In terms of type 2 inflammation multimorbidity, 75.1% of included individuals had one, 21.3% two and 3.5% three diagnoses, respectively.

Practical Algorithm on Topical Treatment of Flaring Atopic Dermatitis (AD) With or Without Secondary Infection

Schachner LA, Hebert AA, Sidbury R, et al. J Drugs Dermatol. 2025;24(6):621-630. doi:10.36849/JDD.8967

Abstract

Acute exacerbations or flares are a key characteristic of atopic dermatitis (AD), often associated with sleep deprivation, as well as experiences of stigmatization, social withdrawal, anxiety, and depression. Local skin colonization with Staphylococcus aureus (SA) is a key contributor to AD, particularly to AD flares. Treating SA-driven active AD, especially in cases where skin that is secondarily infected complicates management, calls for a carefully balanced approach that serves to calm AD activity and clear local infection and SA related colonization.

The methodological approach included a systematic literature review to inform an expert panel before a face-to-face meeting to develop a practice-based algorithm for managing AD flares with or without secondary infection. A panel of nine experts in dermatology, including both Board-certified dermatologists and pediatric dermatologists, engaged in a discussion followed by an online review to refine the algorithm and to provide clear guidance on the topical treatment of flaring AD with or without AD skin that is secondarily infected.

Sputum quality affects assessment of airway microbiology in childhood asthma

Taylor, S.L., Brooks, C.R., Elms, L. et al. Respir Res 26, 209 (2025). https://doi.org/10.1186/s12931-025-03266-x

Abstract

Background

The analysis of sputum is the principal basis for characterising lower airway microbiology in those with chronic respiratory conditions. For such analysis to be informative, samples that poorly reflect the lower airways must be identified and removed. Our cross-sectional study explored the relationship between the quality of sputum samples and their microbiological content. We further investigated the impact of excluding low quality samples on observed microbiota-disease relationships in childhood asthma.

Methods

Induced sputum was collected from children with or without asthma. Sputum quality was assessed according to squamous cell%, cell viability%, detection of sputum plugs, and salivary α-amylase levels.