Allergen-specific immunotherapy and evidence: A European regulatory perspective

Detlef Bartel, Andreas Bonertz, Diana Hartenstein, Stefan Kaul, Iris Lauer, Christina Reeb, Karen Rösner-Friese, Katja Sliva, Julia Zimmer, Stefan Vieths, and Vera Mahler. Allergologie Select. 2023; 7: 198-210. doi: 10.5414/ALX02413E.

Abstract

In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level.

Advocacy of Precision Allergy Molecular Diagnosis in Decision Making for the Eligibility of Customized Allergen Immunotherapy.

González-Pérez R, Poza-Guedes P, Pineda F, Sánchez-Machín I.  Curr Issues Mol Biol. 2023 Dec 12;45(12):9976-9984. doi: 10.3390/cimb45120623. 

Abstract

Distribution of specific IgE (sIgE) serodominance to a comprehensive panel of 11
molecular mite allergens studied using a microarray in a selected population (n = 60)
 of youngsters (<20 y.o.) with different allergic phenotypes.

Allergen immunotherapy (AIT) with aeroallergens is the only disease-modifying treatment for patients with different allergic conditions. Despite the effectiveness of AIT having been proven in both randomized controlled trials and real-world studies, it remains underused in less than 10% of subjects with allergic rhinitis (AR) and/or asthma (A). We aimed to determine the current eligibility for house dust mite (HDM) AIT by means of a precision allergy molecular diagnosis (PAMD@) model in a selected cohort of youngsters with different allergic phenotypes according to the available evidence.

Development of the Rapid Cough Questionnaire (RCQ): Key Item Identification

Koo HK, Moon JY, Kim JW, Jang SH, Kwon JW, Lee BJ, Park YB, Kim DK. Ann Allergy Asthma Immunol. 2023 Dec 27:S1081-1206(23)01510-7. doi: 10.1016/j.anai.2023.12.025.

Abstract

Background: The Leicester Cough Questionnaire (LCQ) is a reliable tool for measuring the multidimensional impact of cough on patients' quality of life; however, its scoring algorithm is too lengthy and complex for routine clinical use.

Objective: This study aimed to develop a simplified version of the LCQ, the Rapid Cough Questionnaire (RCQ), as a substitute in clinical practice and to validate the RCQ using an independent cohort.

Methods: To select items for the RCQ score, a correlation network was used to determine the items from each domain that were strongly correlated with the total LCQ score. The final items for the RCQ were selected based on the centrality of the node degree, betweenness, and closeness in the correlation network.

Results: The RCQ score was derived from only three items: tiredness (LCQ3) in the physical domain, the feeling of being fed up (LCQ13) in the psychological domain, and annoyance with partner/family/friends (LCQ19) in the social domain. The correlation between the LCQ and RCQ was high, with a coefficient of 0.93 (P&lt;0.001).

Real-world reporting rates of administration-site reactions with on-demand treatment of hereditary angioedema attacks

Tachdjian R, Savic S, Fridman M, Frade JP, Fasehun M, Audhya PK.Allergy and Asthma Proceedings, Volume 45, Number 1, 1 January 2024, pp. 37-43(7)

Abstract:

Background:

Hereditary angioedema (HAE) is characterized by recurrent and unpredictable episodes of subcutaneous and/or submucosal swelling.

Objective:

To characterize the real-world treatment burden associated with existing on-demand therapies, we analyzed administration-site adverse drug reactions (ADR) associated with approved on-demand HAE therapies reported in the U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS).

Methods:

We searched the FAERS database from October 1, 2009, to March 31, 2022, for reports of all FDA-approved on-demand therapies for HAE: plasma-derived C1-inhibitor (pdC1-INH), ecallantide, icatibant, and recombinant C1-inhibitor (rhC1-INH). ADRs in which the drug was listed as the “primary suspect” were recorded for each drug.

Predictive Factors of Hospitalization and Emergency Visits Among Children With Asthma.

Al Ghadeer H A, Aldandan J K, Alessa M A, et al. (January 01, 2024) Cureus 16(1): e51487. doi:10.7759/cureus.51487

Abstract

Introduction

A chronic diverse inflammatory disease, asthma affects millions of people worldwide. To control asthma, standardized care is essential. Children with asthma who receive appropriate care have lower emergency room (ER) visits and hospital stays as well as a higher quality of life than children who do not receive appropriate care. We aim to evaluate the predictive variables of hospitalization and ER visits in children with asthma.

Methodology

In 2022 and 2023, a cross-sectional descriptive study was carried out on children with asthma and their caregivers who were attending primary health care clinics in the eastern region of Saudi Arabia. We used the Childhood Asthma Control Test (C-ACT) to evaluate asthma control.

Telehealth interventions for transition to self-management in adolescents with allergic conditions: A systematic review.

Sullivan MO, Curtin M, Flynn R, Cronin C, Mahony JO, Trujillo J.  Allergy. 2023 Dec 1. doi: 10.1111/all.15963.

Abstract

Telehealth is an emerging approach that uses technology to provide healthcare remotely. Recent publications have outlined the importance of supporting the transition to self-management of adolescents with allergic conditions. However, no synthesis of the evidence base on the use and impact of telehealth interventions for this purpose has been conducted to date.

This review achieves these aims, in addition to exploring the language use surrounding these interventions, and their implementation. Four databases were searched systematically. References were independently screened by two reviewers. Methodological quality was assessed using the Mixed Methods Appraisal Tool. A narrative synthesis was undertaken. Eighteen articles were included, reporting on 15 telehealth interventions. A total of 86% targeted adolescents with asthma. Mobile applications were the most common telehealth modality used, followed by video-conferencing, web-based, virtual reality and artificial intelligence.

Exposure to air pollution concentrations of various intensities in early life and allergic sensitisation later in childhood.

Ziou, M., Gao, C.X., Wheeler, A.J. et al.  BMC Pulm Med 23, 516 (2023). https://doi.org/10.1186/s12890-023-02815-8

Abstract

Background

Evidence on the relationship between air pollution and allergic sensitisation in childhood is inconsistent, and this relationship has not been investigated in the context of smoke events that are predicted to increase with climate change. Thus, we aimed to evaluate associations between exposure in two early life periods to severe levels of particulate matter with an aerodynamic diameter < 2.5 μm (PM2.5) from a mine fire, background PM2.5, and allergic sensitisation later in childhood.

Methods

PM2.5 concentrations (μg/m3) from both
sources mapped to Statistical Area level 1

We measured specific immunoglobulin E (IgE) levels for seven common aeroallergens as well as total IgE levels in a cohort of children who had been exposed to the Hazelwood coal mine fire, either in utero or during their first two years of life, in a regional area of Australia where ambient levels of PM2.5 are generally low. We estimated personal exposure to fire-specific emissions of PM2.5 based on a high-resolution meteorological and pollutant dispersion model and detailed reported movements of pregnant mothers and young children during the fire.

Why the role of mHealth in allergy diagnosis and treatment adherence cannot be overlooked

Szylling A, Raciborski F, Wojas O, Furmańczyk K, Krzych-Fałta E, Bousquet J, Samoliński B. Clin Transl Allergy. 2023 Oct;13(10):e12298. doi: 10.1002/clt2.12298.

Abstract

Background

Allergic diseases—rhinitis and asthma—are the most common chronic conditions affecting adults. Traditional approaches to allergy diagnosis and treatment do not meet the health needs of all patients. Treatment adherence remains a challenge for physicians. The ubiquity of Internet access paired with limited in-person contact with medical personnel in the course of the COVID-19 pandemic demonstrated the potential of mHealth in communicating health information.