Expert Perspectives on Next Generation Health Guidelines: How to Integrate RWE in EBM

Del Giacco S, Canonica GW, Agache I et al.  Pragmat Obs Res. 2025 Sep 11;16:169-177. doi: 10.2147/POR.S487342.

Abstract: 

Integrating real-world evidence (RWE) into evidence-based medicine (EBM) enhances healthcare decision-making. RWE provides insights into the real-world effectiveness and safety of therapies and health technologies, filling gaps that clinical trials may leave. EBM, which concentrates on therapeutic issues, depends on rigorous evaluation of evidence, including data from randomized controlled trials (RCTs) and RWE. Combining evidence from RCTs and RWE when forming recommendations offers a comprehensive understanding of benefits and risks by considering their strengths, limitations, and standardized methods. The 2nd European Academy of Allergy & Clinical Immunology/Respiratory Effectiveness Group (EAACI/REG) Workshop, held in Rome, Italy, on October 4th, 2023, discussed integrating RWE and EBM. The goals were to develop recommendations for high-quality RWE and its inclusion in evidence syntheses, with a particular focus on airway diseases.

Subcutaneous Allergen Immunotherapy in Adults Allergic to House Dust Mites: A Phase 3 Randomized Controlled Trial

C. Bachert, H. Hoogeveen, R. ten Have, et al.  Allergy (2025): 1–10, https://doi.org/10.1111/all.70063.

ABSTRACT

Background

Subcutaneous allergen immunotherapy (SCIT) has a longstanding history as a safe and effective treatment. Nevertheless, to meet the European Medicines Agency's regulatory requirements for continued market authorization, its efficacy and safety must be confirmed in a pivotal Phase III trial.

Graphical Abstract

Objective

Based on a successful Phase II dose-finding study, the aim was to confirm the safety and efficacy of a subcutaneous house dust mites (HDM) preparation in a randomized controlled trial using an optimal higher dose than the current maintenance dose.

Method

Seven hundred sixty-seven subjects were randomized in a 1:1 ratio to 1-year treatment with SCIT-product at a dose of 50,000 AUeq/mL or placebo.

Proceedings of the Second Artificial Intelligence in Primary Immunodeficiencies (AIPI) Meeting

Rivière JG, Bastarache L, Campos LC et al. The Journal of Allergy and Clinical Immunology (2025), doi: https://doi.org/10.1016/j.jaci.2025.09.002.

Abstract

AI Integration Pathways in Primary Immunodeficiencies.
Radial diagram summarizing the meeting discussion themes

The use of artificial intelligence (AI) in primary immunodeficiencies (IEI) offers transformative potential in diagnostics and disease management but faces multiple challenges that were discussed at the second Artificial Intelligence in Primary Immune Disease (AIPI) conference, held in New York City (March 19–22, 2025). The conference addressed seven themes: predictive diagnostic algorithms, health equity, industry collaboration, advanced computational tools like large language models (LLMs), patient-led AI initiatives, multi-omics integration, and implementation science.

Stapokibart for Severe Uncontrolled Chronic Rhinosinusitis With Nasal Polyps The CROWNS-2 Randomized Clinical Trial

Shen S, Yan B, Wang M, et al. JAMA. 2025;334(11):962–972. doi:10.1001/jama.2025.12515

Key Points

Question  Among patients with severe chronic rhinosinusitis with nasal polyps taking a daily intranasal corticosteroid, does stapokibart, a novel anti–interleukin 4Rα monoclonal antibody, decrease nasal polyps and reduce symptoms of nasal congestion?

Findings  In this randomized clinical trial that included 179 participants from China, stapokibart significantly reduced polyp size and improved nasal symptoms at 24 weeks in patients with severe chronic rhinosinusitis with nasal polyps.

Meaning  Among patients with severe chronic rhinosinusitis with nasal polyps treated with a daily intranasal corticosteroid, stapokibart reduced polyp size and severity of nasal symptoms at 24 weeks.

Abstract

Validation of the Urticaria Activity Score for Cold Urticaria

Grekowitz E, Salameh P, Altrichter S et. al. J Allergy Clin Immunol Pract. 2025 Sep;13(9):2329-2337.e3. doi: 10.1016/j.jaip.2025.04.012. 

Abstract

Background
Cold urticaria (ColdU) is characterized by the appearance of wheals and/or angioedema and itch after exposure to cold stimuli. The Cold Urticaria Activity score (ColdUAS) is a newly devised patient-reported outcome measure (PROM) assessing disease activity in ColdU.

Objectives
We aimed to validate the ColdUAS according to PROM guidelines, assess the optimal documentation period, and develop a scoring computation algorithm.

Methods
We instructed 71 patients with typical and atypical ColdU to complete the ColdUAS questionnaire over 4 consecutive weeks and asked to fill out additional anchor instruments including global assessment tools and validated quality of life measures.

Efficacy and safety of Sublingual immunotherapy for allergic rhinitis: an overview of systematic reviews and meta analyses

Wang, Z., Wang, N., Liang, X. et al.  Eur Arch Otorhinolaryngol (2025). https://doi.org/10.1007/s00405-025-09664-7

Abstract

Introduction

Reappraisal of Systematic reviews/Meta analyses on Sublingual Immunotherapy for Allergic Rhinitis: Evidence for Clinical Practice and Decision-Making.

Methods

A comprehensive computerized search was conducted across PubMed, Embase, the Cochrane Library, Web of Science, CNKI, VIP, WANFANG, and CBM databases from their inception to June 8, 2025, to systematically identify Systematic reviews and Meta analyses on Sublingual Immunotherapy for allergic rhinitis. A citation overlap matrix was constructed to calculate the corrected covered area, assessing the degree of primary study overlap. The risk of bias, methodological quality, reporting quality, and certainty of evidence in the included Systematic reviews/Meta analyses were evaluated using ROBIS, AMSTAR-2, PRISMA 2020, and GRADE tools, respectively. Both quantitative and qualitative analyses were performed on the primary outcomes to derive a more comprehensive and in-depth understanding.

Results

Cartesian heatmap of the scores of each item in PRISMA 2020.
Note: Green indicates compliance; Gray indicates partial compliance;
Red indicates non-compliance

A total of 20 Systematic reviews/Meta analyses were included in this umbrella review. The corrected covered area of 6.391% derived from the citation matrix analysis indicated a modest degree of primary study overlap among the included literature.

Differential Diagnosis of Chronic Spontaneous Urticaria

Gialama D, Bonnekoh H, Rothermel NDet al. J Allergy Clin Immunol Pract. 2025 Sep;13(9):2242-2250. doi: 10.1016/j.jaip.2025.06.019. 

Abstract

Patients with chronic recurrent wheals most commonly receive the diagnosis of chronic spontaneous urticaria, although a number of autoimmune, autoinflammatory, and malignant diseases can be suspected based on certain red flags. These warning signs are a wheal duration of more than 24 hours, post-inflammatory hyperpigmentation, and systemic symptoms such as arthralgia and fever and/or elevated inflammatory markers. 

Urticarial exanthema: (A) Chest, (B) back, and (C) hands.

Here, we detail the case of an adult patient who initially received the diagnosis of chronic spontaneous urticaria, discussing possible differential diagnoses and outlining options for treating the patient once a diagnosis has been established.

Bibliometric analysis of the association between air pollution and allergic rhinitis

Geng Z, Ma Y, Qi X. Glob Health Action. 2025 Dec;18(1):2547434. doi: 10.1080/16549716.2025.2547434.

Abstract

Background: Allergic rhinitis (AR) is an increasingly prominent global public health issue, where air pollution significantly contributes to its rising incidence. Although numerous studies have explored the link between air pollution and AR pathogenesis, comprehensive summaries are still limited.

Objective: This study performs a bibliometric analysis to identify research hotspots and emerging trends, offering insights into AR prevention and management.

Methods: Literature related to on air pollution and AR was retrieved from the Web of Science Core Collection database. Visualization tools, including VOSviewer, CiteSpace, and Bibliometrix R, were utilized to analyze contributions by countries, institutions, authors, journals, and keywords, with the aim of predicting future research trends.

Number of global publications related to air pollution
and allergic rhinitis

Results: A total of 4,020 authors, 1,368 institutions, and 75 countries contributed to 753 publications. The United States leads in research contributions, while China has shown rapid growth since 2012.