BACKGROUND:Allergic rhinitis (AR) prevalence is increasing worldwide. However, while information on the economic burden of AR remains limited globally, nationwide data for Japan are similarly scarce. Therefore, we investigated healthcare utilization and prescription drug costs for seasonal AR using a nationwide claims database, primarily focusing on spring AR. METHODS:This observational study used the National Database of Health Insurance Claims (2018-2019). Patients with spring AR were defined as those with an AR-related diagnosis and prescriptions covering ≥14 days in each of the two spring pollen seasons (January-April) in 2018 and 2019 (pre-COVID-19 years with heavy pollen dispersal). Patients with summer (May-August) and autumn (September-December) AR were similarly identified, whereas patients with perennial-only AR were excluded. We calculated the number of patients, healthcare visits, drug costs, and the correlation between the number of spring AR patients and pollen counts. RESULTS:Spring AR involved 12.9 million patients (female-to-male ratio, 1.36), with annual prescription drug costs of 101.8 billion yen (7874 yen per patient), a mean of 3.05 visits per season, and 83% of patients visiting outpatient clinics without beds. Regional patient numbers were correlated with pollen counts (Spearman's r = 0.61). Summer and autumn AR involved 5.7 million and 6.1 million patients, with costs of 38.7 and 42.4 billion yen, respectively. CONCLUSIONS:Patients with seasonal AR identified using strict criteria totaled 24.7 million annually, with drug costs totaling 182.9 billion yen. These figures represent a conservative estimate of the minimum medical expenditure for seasonal AR in Japan.

Allergic Rhinitis and its Impact on Asthma (ARIA) was, up until 2017, a guideline using the best evidence (Grading of Recommendations, Assessment, Development and Evaluation, GRADE) and developed as a change management strategy. A second change management strategy-in collaboration with the European Academy of Allergy and Clinical Immunology (ARIA-EAACI)-was developed as a person-centred, digitally enabled, artificial intelligence-assisted care (person-centred care) with strong political involvement. The digital tools of ARIA are mainly based on MASK-air, an Organisation for Economic Co-operation and Development (OECD) Best Practice for integrated care for chronic diseases. Artificial intelligence was used, in particular, to approach the patients' views and expectations. The current paper describes the steps to build and achieve a new change management strategy. The future of the Change Management strategy is (i) a collaboration between ARIA and EAACI, (ii) the development of ARIA 2024-2025 guidelines, (iii) the new ARIA-MeDALL classification of multimorbid airway diseases and (iv) embedding MASK-air in a registry for severe allergic diseases. The ultimate goals of the ARIA-EAACI change management strategy will be (i) the transformation of health and care in rhinitis and asthma multimorbidity and (ii) the development of novel guidelines and policies in a cost-effective manner, improving shared-decision-making.

ABSTRACT Allergic Rhinitis and its Impact on Asthma (ARIA) was, up until 2017, a guideline using the best evidence (Grading of Recommendations, Assessment, Development and Evaluation, GRADE) and developed as a change management strategy. A second change management strategy—in collaboration with the European Academy of Allergy and Clinical Immunology (ARIA‐EAACI)—was developed as a person‐centred, digitally enabled, artificial intelligence‐assisted care (person‐centred care) with strong political involvement. The digital tools of ARIA are mainly based on MASK‐air, an Organisation for Economic Co‐operation and Development (OECD) Best Practice for integrated care for chronic diseases. Artificial intelligence was used, in particular, to approach the patients' views and expectations. The current paper describes the steps to build and achieve a new change management strategy. The future of the Change Management strategy is (i) a collaboration between ARIA and EAACI, (ii) the development of ARIA 2024‐2025 guidelines, (iii) the new ARIA‐MeDALL classification of multimorbid airway diseases and (iv) embedding MASK‐air in a registry for severe allergic diseases. The ultimate goals of the ARIA‐EAACI change management strategy will be (i) the transformation of health and care in rhinitis and asthma multimorbidity and (ii) the development of novel guidelines and policies in a cost‐effective manner, improving shared‐decision‐making.

BACKGROUND:House dust mite (HDM) allergic rhinitis (HDM-AR) fluctuates over time with exposure conditions, making disease activity assessment essential when demonstrating treatment efficacy. We conducted post hoc tertile analyses to more accurately assess the efficacy of 300 IR HDM sublingual immunotherapy (SLIT) tablet in moderate-to-severe HDM-AR pediatric patients during periods of increased disease activity. METHODS:Data from two Japanese randomized controlled trials of 300 IR HDM SLIT-tablet were used to assess the average adjusted symptom score (AASS) and average combined symptom and medication score (ACSMS). To determine the impact of HDM-AR activity, placebo group scores during the primary period (end of treatment) at each center were ranked from lowest to highest to establish three tertiles. Scores differences between SLIT and placebo were analyzed in each tertile using ANCOVA. RESULTS:The first analysis included patients aged 5-16 years (300 IR = 193, placebo = 210). During the primary period, the effect of the SLIT-tablet, estimated at -13.1% (AASS) and -12.9% (ACSMS) versus placebo overall, was more pronounced in the highest tertile (relative differences -27.3% and -28.5%, respectively), with similar results across age groups. The second analysis including a pool of adolescents (300 IR = 120, placebo = 135) showed an overall effect of -19.9% (AASS) and -21.2% (ACSMS) with 300 IR versus placebo, with again greater improvements in the highest tertile (-32.5% and -34.1%, respectively). CONCLUSION:The greatest improvements occurred in the tertile where pediatric patients exhibited higher disease activity. This underscores the true efficacy of 300 IR HDM SLIT-tablet during periods when patients experience the most troublesome symptoms.

BACKGROUND:Oral and ocular medications are frequently used in the treatment of allergic rhinitis (AR). As part of the update of the Allergic Rhinitis and its Impact on Asthma (ARIA)-EAACI guidelines, this manuscript presents the ARIA-EAACI 2024-2025 recommendations for oral and ocular treatments. METHODS:The ARIA-EAACI 2024-2025 guideline panel issued recommendations following the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) evidence-to-decision framework. Several sources of evidence were used to inform panel judgements and recommendations, including systematic reviews, mHealth and pharmacovigilance data as well as a survey on costs. RESULTS:Eight guideline questions concerning oral treatments for AR and three questions concerning ocular treatments were addressed. These questions led to the recommendations. Overall, these questions concern the choice between different classes of medication. They also discuss the role of oral antihistamines (OAH), leukotriene receptor antagonists (LTRA), ocular antihistamines (OcAH) and ocular mast cell stabilisers. Four questions had not been previously evaluated in ARIA guidelines, while, for the other four, there was a change in the strength or directionality of the recommendations. Overall, these guidelines recommend using intranasal corticosteroids over OAH and using OAH over LTRA. Moreover, they suggest using OAH over OcAH and suggest being against adding LTRA to OAH. Finally, considerations for choosing between different individual OAHs are presented. CONCLUSION:This ARIA-EAACI 2024-2025 article supports patients, their caregivers and healthcare professionals in choosing oral and ocular treatments for AR. Decisions on treatment should consider the clinical variability of the disease, patients' values and the affordability of medications.

In recent years, the prevalence of seasonal allergic rhinitis has increased rapidly in Japan, becoming a social problem. Therefore, we evaluated the effect of tablets containing Lacticaseibacillus paracasei KW3110 (L. paracasei KW3110) on allergic symptoms in the nose and eyes. In a randomized, double-blind, placebo-controlled, parallel-group study, 120 healthy adults with mild to moderate allergic rhinitis ingested either a placebo tablet or a test tablet containing L. paracasei KW3110 for 12 weeks (from January to April). Subjects who did not regularly use medication and experienced nasal and eye discomfort in early spring were selected. Allergic symptoms in the nose and eyes were assessed using subjective symptom surveys and diagnosis by an otorhinolaryngologist. Compared with the placebo group, the L. paracasei KW3110 group showed a significant improvement in the score of "nasal symptoms" (p < 0.05) and "outdoor activities" (p < 0.05) in the Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ No.1) at 4 weeks when pollen dispersal begins, and "runny nose" (p < 0.05) in a diary questionnaire on nasal and eye symptoms at 8 weeks. Diagnosis by an otorhinolaryngologist showed a significant decrease in the score of "paroxysmal sneezing or rhinorrhea" (p < 0.05) and "classification of severity of allergic rhinitis symptoms" (p < 0.05) at 4 weeks, and the number of subjects scoring "worse" (p < 0.05) in the efficacy assessment. These findings suggest that intake of L. paracasei KW3110 is effective in alleviating nasal symptoms in subjects with mild to moderate allergic rhinitis, which can be useful for preventing allergic rhinitis without medication. https://www.umin.ac.jp/, identifier UMIN000053239.

BACKGROUND AND OBJECTIVES:The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines classify rhinitis as "intermittent" or "persistent" and "mild" or "moderate-severe". Objectives: To assess ARIA classes in a real-world study in terms of phenotypic differences and their association with asthma. METHODS:We performed a cross-sectional real-world study based on users of the MASK-air® app who reported data for at least 3 different months. We assessed the frequency of users according to the ARIA classes and compared these classes in terms of rhinitis symptoms, use of comedication, frequency of comorbid asthma, and the association between comorbid asthma and rhinitis control. RESULTS:A total of 2273 users (180 796 days) were assessed. Most users had moderate-severe rhinitis (n=2003; 88.1%) and persistent rhinitis (n=1144; 50.3%). The frequency of patients with probable asthma was 35.7% (95%CI, 34.5%-37.0%) for intermittent rhinitis and 48.5% (95%CI, 47.1%-49.9%) for persistent rhinitis. The maximum values on the visual analog scale (VAS) for rhinitis symptoms and the combined symptom-medication score were lower in patients with mild rhinitis than in those with moderate-severe rhinitis (irrespective of whether they had persistent or intermittent rhinitis). In most ARIA classes, VAS nose and VAS eye and rhinitis comedication were more frequent in patients with rhinitis+asthma than in those with rhinitis alone. CONCLUSIONS:This study suggests that the presence of asthma is more closely related to persistence of rhinitis than to severity and that the presence of comorbid asthma may be associated with poorer control of rhinitis across the different ARIA classes.

Background Allergic rhinitis (AR) impacts quality of life, work and school productivity. Over the last years, an important body of evidence resulting from mHealth data has led to a better understanding of AR. Such advances have motivated an EAACI-endorsed update of the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines (ARIA 2024-2025). This manuscript presents the ARIA 2024-2025 recommendations for intranasal treatments, one of the mainstays for AR management.Methods The ARIA 2024-2025 guideline panel issued recommendations following the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) evidence-to-decision framework. Several sources of evidence were used to inform panel judgments and recommendations, including systematic reviews, evaluation of mHealth and pharmacovigilance data, as well as a survey of experts on costs.Results Eleven guideline questions concerning intranasal treatments for AR were prioritized, leading to recommendations. Overall, these questions concern the choice between different classes of intranasal medications-most notably, intranasal corticosteroids (INCS), antihistamines (INAH), fixed combinations of INAH+INCS and decongestants-or between different individual medications within each class. Four questions had not been evaluated in previous ARIA guidelines, while for the other three there was a change in the strength or directionality of recommendations. Overall, recommendations point to the suggested use of INAH+INCS over INAH or INCS and INCS over INAH.Conclusion This ARIA 2024-2025 article supports patients, their caregivers, and healthcare professionals in choosing an intranasal treatment. However, decisions on AR treatment should consider the clinical variability of the disease, patients' values, and the affordability of medications.

Invariant Natural killer T (iNKT) cells exhibit cytotoxic activity and immunomodulatory functions and have gained interest in cancer immunotherapy. We conducted a phase 1, first-in human clinical trial to evaluate the safety and efficacy of clinical-grade allogeneic iNKT cells generated from induced pluripotent stem cells (iPSC-iNKT cells) in patients with recurrent head and neck cancer (jRCT2033200116). The primary endpoint was the incidence of dose-limiting toxicity (DLT). The secondary endpoints were to assess safety and efficacy, as well as to evaluate immunological dynamics. iPSC-iNKT cells were administered intra-arterially to 10 patients. One subject developed grade 3 skin rash at the second dose, identified as DLT. No other severe adverse events were observed in any patients. Tumor progression was suppressed in two patients, in whom clonal expansion of memory- and effector-phenotype CD8+ T cells was observed, along with activation of the IFN-γ signaling pathway. Here, we show that iPSC-iNKT cells are safe and possess therapeutic potential as an immunotherapy for solid tumors.

The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines produced their first edition in 1999, with subsequent revisions in 2008, 2010, 2016 and 2019. A new iteration of ARIA-ARIA 2024-2025-in collaboration with EAACI is currently being developed, focusing on the management of allergic rhinitis. ARIA 2024-2025 follows the GRADE framework and is endorsed by the European Academy of Allergy and Clinical Immunology (EAACI). A set of approaches has been used to develop guideline questions, including surveying key opinion leaders and using artificial intelligence (AI)-based tools to analyse web searches on allergic rhinitis and to generate questions. Each prioritised guideline question is assessed through an Evidence-to-Decision (EtD) framework. EtDs support the systematic and transparent formulation of recommendations, comprising 12 criteria for which the best available evidence should be sought. In the context of ARIA-EAACI 2024-2025, such evidence is derived not only from randomised controlled trials but also-among others-from patient-generated data sources that better reflect the affected individuals' perspectives. Moreover, ARIA-EAACI 2024-2025 incorporates evidence on planetary health. Developed guideline recommendations will support the creation of digitalised decision algorithms and care pathways. This paper describes the methodology used to develop the person-centred, digitally enabled and AI-assisted ARIA-EAACI 2024-2025. Among others, it describes (i) the development and prioritisation of guideline questions, (ii) sources of evidence for EtDs and (iii) the development of digitalised decision algorithms and care pathways.

INTRODUCTION:Adherence to controller medication is a major problem in asthma management, being difficult to assess and tackle. mHealth apps can be used to assess adherence. We aimed to assess the adherence to inhaled corticosteroids+long-acting β2-agonists (ICS+LABA) in users of the MASK-air® app, comparing the adherence to ICS+formoterol (ICS+F) with that to ICS+other LABA. MATERIALS AND METHODS:We analysed complete weeks of MASK-air® data (2015-2022; 27 countries) from patients with self-reported asthma and ICS+LABA use. We compared patients reporting ICS+F versus ICS+other LABA on adherence levels, symptoms and symptom-medication scores. We built regression models to assess whether adherence to ICS+LABA was associated with asthma control or short-acting beta-agonist (SABA) use. Sensitivity analyses were performed considering the weeks with no more than one missing day. RESULTS:In 2598 ICS+LABA users, 621 (23.9%) reported 4824 complete weeks and 866 (33.3%) reported weeks with at most one missing day. Higher adherence (use of medication ≥80% of weekly days) was observed for ICS+other LABA (75.1%) when compared to ICS+F (59.3%), despite both groups displaying similar asthma control and work productivity. The ICS+other LABA group was associated with more days of SABA use than the ICS+F group (median=71.4% versus 57.1% days). Each additional weekly day of ICS+F use was associated with a 4.1% less risk in weekly SABA use (95%CI=-6.5;-1.6%;p=0.001). For ICS+other LABA, the percentage was 8.2 (95%CI=-11.6;-5.0%;p<0.001). CONCLUSIONS:In asthma patients adherent to the MASK-air app, adherence to ICS+LABA was high. ICS+F users reported lower adherence but also a lower SABA use and a similar level of control.

BACKGROUND:This study aimed to clarify the diagnostic and predictive factors for perennial allergic rhinitis (PAR) onset in children by analyzing the results of the Chiba High-risk Birth Cohort for Allergy study, which examined newborns with a family history of allergies.METHODS:Overall, 306 pregnant women were recruited. Their newborns were examined by otolaryngologists and pediatric allergists at 1, 2, and 5 years of age. Participants with clinical and laboratory data available at all consultation points were considered eligible.RESULTS:Among 187 eligible participants, the prevalence rates of PAR were 2.1%, 4.3%, and 24.1% at 1, 2, and 5 years of age, respectively. AR-specific nasal local findings and eosinophils in nasal smear were observed in a substantial number of patients with PAR at 1 and 2 years of age. Factors present up to 2 years of age that were associated with PAR onset at 5 years of age, in descending order, were as follows: sensitization to house dust mites (HDM), nasal eosinophilia, and sensitization to cat dander. In 44 cases with HDM sensitization, nasal eosinophilia up to 2 years of age achieved a sensitivity of 76.0% and a specificity of 73.7% for predicting PAR onset at 5 years.CONCLUSIONS:Rhinitis findings and nasal eosinophilia are useful auxiliary diagnostic items for pediatric PAR. Sensitization to HDM and nasal eosinophilia were the most influential factors associated with future PAR onset. A combination of these factors may facilitate the prediction of PAR onset.

The traditional healthcare model is focused on diseases (medicine and natural science) and does not acknowledge patients' resources and abilities to be experts in their own lives based on their lived experiences. Improving healthcare safety, quality, and coordination, as well as quality of life, is an important aim in the care of patients with chronic conditions. Person-centered care needs to ensure that people's values and preferences guide clinical decisions. This paper reviews current knowledge to develop (1) digital care pathways for rhinitis and asthma multimorbidity and (2) digitally enabled, person-centered care.(1) It combines all relevant research evidence, including the so-called real-world evidence, with the ultimate goal to develop digitally enabled, patient-centered care. The paper includes (1) Allergic Rhinitis and its Impact on Asthma (ARIA), a 2-decade journey, (2) Grading of Recommendations, Assessment, Development and Evaluation (GRADE), the evidence-based model of guidelines in airway diseases, (3) mHealth impact on airway diseases, (4) From guidelines to digital care pathways, (5) Embedding Planetary Health, (6) Novel classification of rhinitis and asthma, (7) Embedding real-life data with population-based studies, (8) The ARIA-EAACI (European Academy of Allergy and Clinical Immunology) strategy for the management of airway diseases using digital biomarkers, (9) Artificial intelligence, (10) The development of digitally enabled, ARIA person-centered care, and (11) The political agenda. The ultimate goal is to propose ARIA 2024 guidelines centered around the patient to make them more applicable and sustainable. (c) 2024 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).

BACKGROUND:The symptoms of house dust mite (HDM)-induced allergic rhinitis (AR) vary with changes in exposure related to the weather or the domestic environment. In allergen immunotherapy (AIT) studies, a certain level of AR disease activity is necessary to demonstrate treatment efficacy; the latter can be underestimated if a substantial proportion of the patient population is weakly symptomatic.OBJECTIVE:To better estimate the real treatment effect of a HDM sublingual AIT (SLIT) tablet, we analysed the results of natural field studies in detail by applying a tertile approach.METHODS:We used data from three randomised, controlled trials (RCT) in a total of 2585 patients with AR treated with the 300 index of reactivity (IR) HDM SLIT-tablet or placebo. The study centres were grouped into tertiles according to the level of combined symptom and medication scores in patients in the placebo group. In each tertile, the difference between SLIT and placebo was assessed through an analysis of covariance.RESULTS:In the three RCTs, combined scores were found to be similar in the SLIT and placebo groups in the low tertiles. The treatment effect of the 300 IR HDM tablet increased in the medium and high tertiles, with notably significant differences versus placebo in the highest tertile and greater (ranging from -21% to -39%) than in the entire study population (-13% to -20%). The positive relationship between treatment efficacy and the combined score in each tertile was independent of the RCT and the score used.CONCLUSION AND CLINICAL RELEVANCE:Application of the tertile approach to AIT studies in a field in which many variables interact strongly might provide more accurate and meaningful measurements of efficacy and benefit for patients, better reflecting their real-life condition.

Background: The 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR). To provide a comprehensive review of the 300IR HDM-SLIT tablet safety profile based on randomized controlled trial (RCT) pooled data and post-marketing (PM) pharmacovigilance data. Methods: Subjects (5–65 years) with confirmed HDM-AR with or without controlled asthma were treated with 300IR or placebo in 8 RCTs. Reported treatment-emergent adverse events (TEAEs) were pooled and analyzed descriptively in subsets of adults/adolescents and children. Adverse reactions (ADRs) collected from spontaneous reporting and PM studies through a pharmacovigilance system since the first marketing authorization were also analyzed. Results: Across RCTs, 1853 subjects were treated with the 300IR HDM-SLIT tablet and 1846 with placebo. In both subsets of adults/adolescents and children whichever their asthma status, treatment-related TEAEs of higher incidence in active groups vs placebo were mostly consistent with mild or moderate local application-site reactions. They were mainly reported on the first days of treatment and decreased over time. 4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported. In PM settings, ADRs reported in more than 235,000 patients were in line with RCT findings. Severe systemic reactions occurred rarely; 12 anaphylactic reactions resolved safely (5 with adrenaline). No new safety signal was raised. Conclusion: Safety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status. Clinical trial registrations: NCT00674700; Retrospectively registered 06 May 2008.NCT01199133; Retrospectively registered 09 September 2010.NCT01527188; Retrospectively registered 01 February 2012.NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.

Background: Diagnosis, classification, and treatment of allergic rhinitis (AR) varies considerably despite the availability of treatment guidelines.Objectives: We aimed to carry out a two-part modified Delphi panel study to elucidate global expert management of AR in real life. Methods: The modified Delphi panel study was composed of two ten-minute online question-naires sent to global AR experts, aiming to identify areas of consensus (defined as >75% respondent agreement) on aspects of their real-world daily practice related to AR diagnosis, classification, and pharmacotherapy. A workshop discussion with respondents held after the first-round questionnaire informed the development of the second-round questionnaire.Results: Eighteen experts (from 7 countries across 3 continents) completed both questionnaires in September-October 2021 and January 2022, respectively. The majority of respondents agreed that diagnosis of AR is best confirmed using a mixture of observation and testing (n = 15) and collaborating with colleagues across other specialties (n = 14). Experts agreed that severity (n = 18), upper/lower respiratory tract involvement (n = 15) and symptom frequency (n = 14) are important factors when classifying AR, however consensus was not reached on which classification tool should be used. Although there were mixed opinions on the preferred pharmacotherapy treatment in the presented case studies, respondents largely agreed on which treatments require less monitoring (intranasal corticosteroid therapies [INCS]) and when treatments should be step-ped down (⠂3 months). Although opinions varied across respondents, some respondents considered as-needed INCS treatment and surgery to be viable treatment options.Conclusion: We identified clear differences between real-world practice and treatment guide-lines related to the management of AR. Furthermore, we recognized differences among physicians concerning their clinical practice in the pharmacological treatment of AR. These findings highlight the need for greater research into the management of AR and further indicate there is still a major gap between treatment guidelines and daily practice, even among specialists, suggesting a need for local guideline adaptation and implementation plans.

BACKGROUND:Early identification of infants at high risk of allergies can improve the efficacy of preventive interventions. However, an established quantifiable risk assessment method in the early postnatal period does not exist. TARC (or CCL17) is a Th2 chemokine used as an activity marker for atopic dermatitis (AD). Therefore, we evaluated the association between cord blood TARC (cTARC) and the development of allergic diseases in childhood. METHODS:This is a high-risk birth cohort for allergy, consisting of children with a family history of allergy. We collected 263 pairs of maternal and child cord blood samples perinatally and child blood samples at ages 1, 2, and 5 years. TARC and allergen-specific immunoglobulin E levels were measured, and the relationship between allergic diseases was analyzed. RESULTS:The median cTARC was 989 pg/mL (interquartile range [IQR]: 667-1430 pg/mL). The cTARC levels in children who developed AD were higher than those in children who did not develop AD, and the association strengthened with younger age (median [IQR] at 1 year: 1285 [816-1965] vs. 933 [662-1330] pg/mL, p < 0.01; at 2 years: 1114 [787-1753] vs. 950 [660-1373] pg/mL, p = 0.02). In the multivariate analysis, cTARC was associated with AD, egg white sensitization, food allergy, allergic rhinitis, and Japanese cedar pollen sensitization. CONCLUSIONS:cTARC was associated with the development of allergic diseases and allergen sensitization in early childhood. These results suggest that, infantile AD-mediated atopic march starts during fetal life, and this immune status is reflected in the cTARC at birth.

Biomarkers for the diagnosis, treatment and follow-up of patients with rhinitis and/or asthma are urgently needed. Although some biologic biomarkers exist in specialist care for asthma, they cannot be largely used in primary care. There are no validated biomarkers in rhinitis or allergen immunotherapy (AIT) that can be used in clinical practice. The digital transformation of health and health care (including mHealth) places the patient at the center of the health system and is likely to optimize the practice of allergy. Allergic Rhinitis and its Impact on Asthma (ARIA) and EAACI (European Academy of Allergy and Clinical Immunology) developed a Task Force aimed at proposing patient-reported outcome measures (PROMs) as digital biomarkers that can be easily used for different purposes in rhinitis and asthma. It first defined control digital biomarkers that should make a bridge between clinical practice, randomized controlled trials, observational real-life studies and allergen challenges. Using the MASK-air app as a model, a daily electronic combined symptom-medication score for allergic diseases (CSMS) or for asthma (e-DASTHMA), combined with a monthly control questionnaire, was embedded in a strategy similar to the diabetes approach for disease control. To mimic real-life, it secondly proposed quality-of-life digital biomarkers including daily EQ-5D visual analogue scales and the bi-weekly RhinAsthma Patient Perspective (RAAP). The potential implications for the management of allergic respiratory diseases were proposed.