Background Hypereosinophilic syndrome (HES) encompasses rare disorders characterized by persistent hypereosinophilia resulting in organ damage. This study assessed demographics, incidence, and prevalence of HES in the United States following the introduction of HES-specific International Classification of Diseases 10th revision, Clinical Modification (ICD-10-CM) codes in 2020. Methods This retrospective analysis used data from patients with HES and ≥12 months of continuous insurance coverage between October 1, 2020, and June 30, 2024, from Optum's de-identified Clinformatics® Data Mart Database. Incidence rates were calculated from the number of new HES cases divided by total person-time at risk, and prevalence from the proportion of HES cases in the population during the study. Results Overall, 695 and 1224 patients fulfilled the incident and prevalent HES case definition, respectively. The overall HES incidence rate (95% CI) was 2.01 (1.87–2.17) per 100,000 person-years, with fluctuations between 2021 and 2024. The overall HES prevalence (95% CI) was 5.32 (5.02–5.62) per 100,000 persons, with increases between 2020 and 2024. Incidence and prevalence increased with age, with an almost even female-to-male ratio (51:49). Conclusions HES had low incidence and prevalence, with increasing prevalence from 2020 to 2024, indicating an increased recording and growing awareness of HES with ICD-10-CM codes usage.
Background Although combined intranasal corticosteroid–antihistamine sprays are approved for allergic rhinitis, evidence supporting their effectiveness in nonallergic rhinitis (NAR) remains limited. Objective To compare the treatment response to fluticasone propionate–azelastine (FP-Aze) for treating NAR and perennial allergic rhinitis (PAR). Methods This prospective observational real-world study enrolled adults with moderate-to-severe PAR or NAR. Participants received FP–Aze nasal spray (50/137 μg), 1 spray per nostril twice daily for 4 weeks. The primary endpoint was the change from baseline in the visual analog scale (VAS) for rhinitis, ranging from 0 to 100 mm. Treatment effectiveness in NAR was assessed for noninferiority, with a prespecified margin of 23 mm on the VAS relative to PAR. Secondary outcomes included evaluation of non-nasal symptoms and quality of life (QoL). Results Patients with moderate-to-severe PAR (n = 108) and NAR (n = 62) were included. FP-Aze significantly improved nasal symptoms in both groups. At Week 4, adjusted mean changes (95% CI) in VAS for rhinitis were −52.20 mm (−57.37, −47.03) in PAR and −48.59 mm (−55.64, −41.54) in NAR. The between-group difference in mean change was 3.61 mm (−5.58, 12.79), meeting the noninferiority criterion. QoL improved significantly in both groups, with no significant between-group differences. Sensitivity analyses excluding patients who used as-needed oral antihistamines yielded consistent results. Treatment was well tolerated, with a bitter taste as the most commonly reported adverse event; no serious adverse events were observed. Conclusion The effectiveness of FP-Aze in moderate-to-severe NAR was noninferior to PAR on the VAS for rhinitis, supporting its use in this population. These findings help address an important evidence gap, as data supporting FP-Aze in NAR remain limited.
Background Although anaphylaxis incidence is rising globally, long-term longitudinal data from Southeast Asia remain scarce. This study evaluates 18-year trends in anaphylaxis visit rates, etiological triggers, and clinical management in Northern Thailand, specifically assessing the impact of institutional protocols implemented in alignment with the 2017 Thai National Clinical Practice Guidelines for Anaphylaxis. Methods We conducted an 8-year retrospective study (2017–2024) at a tertiary university hospital, integrating data with a previous 10-year cohort (2007–2016) under an identical clinical adjudication and exclusion protocol. Cases were identified via ICD-10 codes and manually adjudicated using 2006 NIAID-FAAN clinical criteria. We analyzed demographics, triggers, management metrics, and outcomes using multivariable logistic regression. Longitudinal trends adjusted for annual Emergency Department (ED) volumes were evaluated using a Poisson log-linear regression model with a log offset. Results Among 647 anaphylaxis events (626 patients), the 2017–2024 presentation rate was 360.7/100,000 ED visits in children and 282.4/100,000 in adults. Adjusting for ED volume, Poisson regression revealed a compounding yearly rate increase of 10% in adults (IRR = 1.10, 95% CI: 1.09–1.12, p<0.001), while pediatric rates remained volatile without a longitudinal trend (IRR = 1.01, 95% CI: 0.98–1.05, p=0.40). Total institutional encounters rose significantly (IRR = 1.09, 95% CI: 1.08–1.10, p<0.001). Comparing to the previous 2007–2016 data, food led triggers (49.6%), with growing proportions of shellfish (34.2%) and edible insects (10.5%, p<0.001). Medications caused 20.2% of cases, whereas Hymenoptera stings (10.2%) decreased significantly (p<0.001). Primary manifestations were cutaneous (95.4%), respiratory (66.8%), and gastrointestinal (53.3%). Over the protocol integration timeline, ED intramuscular epinephrine administration rose from 87.5% to 98.3% (p<0.001), and mean door-to-treatment time dropped from 16.3 to 10.3 min (p=0.03). Fatality was zero; however, the discharge prescription rates for self-injectable epinephrine remained stagnant at 7.6%. Conclusions Anaphylaxis ED visit rates demonstrated a significant longitudinal increase over 18 years, driven by the adult population and characterized by an evolving distribution of food triggers toward shellfish and edible insects.
Background Hypereosinophilic syndrome (HES) is a group of rare blood disorders characterized by persistent hypereosinophilia causing organ damage. Differences in underlying pathophysiology give rise to several variants, including idiopathic (I-HES) and lymphocytic (L-HES) subtypes. Oral corticosteroids (OCS) have been the mainstay of treatment for I-HES/L-HES, but long-term use is limited by toxicity. While biologics mark an important recent advance in the treatment of HES, unmet clinical needs in the management of patients remain. This retrospective cohort study examines real-world treatment patterns and disease burden for patients with I-HES/L-HES in the United States. Methods De-identified information from the TriNetX Linked network of electronic health records plus claims was used to establish the first recorded date of HES diagnosis (index date [ID]) for patients between October 01, 2020 and September 12, 2023. Baseline was defined as 12 months prior to ID; patients were followed up until either September 12, 2023, disenrollment from insurance, death, or 2 years post-ID, whichever came first. Primary objective was to describe clinical characteristics and disease burden in the overall I-HES/L-HES population. Secondary objectives included demographics, treatment patterns and clinical outcomes in the overall population, and patient journey to I-HES/L-HES diagnosis (incident cohort only). All analyses were descriptive. Results The overall population included 110 patients; 60.0% were male, mean (standard deviation [SD]) age at first HES diagnosis record was 43.8 (21.3) years, and 52.7% were White. The mean (SD) number of organ systems involved with HES signs and/or symptoms was 2.9 (2.1) at baseline and 2.1 (2.0) at Year 2 of follow-up. Among incident cases of HES (n = 53), the mean (SD) time from first eosinophil count ≥1500 cells/μL to HES diagnosis was 47.9 (75.8) months (n = 13), and the mean (SD) time from the first eosinophil count ≥1500 cells/μL to initiation of HES therapy was 29.0 (42.6) months (n = 6). In the overall population, 50% of patients did not receive treatment within 2 years of follow-up. OCS were the most prescribed therapy; few patients were treated with immunosuppressants, and the use of interleukin-5/receptor alpha-targeted therapies increased over the study period. By end of follow-up, less than 40% of patients had experienced a complete remission and few patients achieved a clinical response. Conclusion HES is associated with substantial disease burden. There remains an unmet need for earlier diagnosis and intervention, and for improved therapeutic options, in I-HES/L-HES.
Background Real-world data on the healthcare resource utilisation (HCRU) and cost burden of eosinophilic granulomatosis with polyangiitis (EGPA) are limited. We assessed all-cause HCRU and costs in patients with EGPA versus a matched general population cohort without EGPA and a severe uncontrolled asthma (SUA) cohort. Methods Primary care data in England from the Clinical Practice Research Datalink Aurum database, with linkage to Hospital Episode Statistics inpatient, outpatient and emergency department records, were analysed. Patients with a new EGPA diagnosis in 2006–2020 and ≥ 1 year of data before diagnosis (index date [ID]) were included and matched using a matching ratio of up to 1:4 with a general population cohort without EGPA and patients with SUA. Follow-up was from ID until deregistration, last data collection, death or study end. HCRU and associated costs were assessed across the 12 months prior to ID, and annually from ID to end of the study period, and by disease states and Five-Factor Score [FFS]. Results A total of 486 patients with EGPA were identified, with a corresponding matched general population cohort of 1938 and SUA cohort of 1005 patients. Annual all-cause HCRU rates during follow-up were higher in the EGPA cohort versus the general population and SUA cohorts for all types of care, particularly in the first year after ID. Patients with an FFS of 0 generally had lower HCRU than those with an FFS ≥1. Annualised total HCRU-associated costs (95% confidence interval [CI]) were higher in the EGPA cohort (£13,978 [12,068, 15,888]) versus the general population (£2303 [2145, 2461]) and matched SUA cohorts (£3571 [3326, 3816]), with cost ratios (95% CI) of 8.3 (7.1, 9.6) and 4.1 (3.6, 4.6) respectively, both p < 0.0001. The greatest cost driver was hospital admissions with cost ratios (95% CI) of 12.3 (9.8, 15.5) and 5.8 (4.7, 7.2) compared with the general population and SUA cohorts, respectively. Median all-cause annualised total costs per patient were 46% and 56% higher among patients with relapse or stable disease, respectively, than among those in remission at ID. Conclusion Patients with EGPA incurred significantly higher annualised HCRU rates and associated costs than both the general population and SUA cohorts, underscoring a substantial clinical and economic burden and highlighting a persistent unmet clinical need in practice.
Introduction X-linked Agammaglobulinemia (XLA) is an inborn error of immunity (IEI) caused by mutations in the BTK gene, resulting in the absence of mature B-cells and altered serum immunoglobulin levels. In Colombia, unified epidemiological and genetic data are lacking. This study aims to characterize XLA patients in the country demographically, phenotypically, and genotypically. Methods A multicenter, observational, cross-sectional study based on clinical records. Thirty-eight patients with B-cell counts <2% and hypogammaglobulinemia were included. Clinical, immunological, and genetic variables and outcomes were analyzed using descriptive statistics in R-Studio. Results Thirty-eight males were analyzed, with a median age at diagnosis of 16 months (IQR 7.2–21.8). Genetic testing was available for 84.2% (n = 32), identifying 15 distinct variants, 53% of which were novel. Sinopulmonary infections were the primary manifestation (92.1%), notably pneumonia (42.1%) and otitis media (39.5%). Median baseline IgG levels were 187 mg/dL. Bronchiectasis was documented in 34.2% of cases. The eight-year survival rate was 71.1%. Discussion The Colombian cohort shows a relatively early diagnosis but a high burden of structural sequelae (bronchiectasis), suggesting a need to optimize immunoglobulin replacement therapy. The high proportion of novel genetic variants underscores the importance of regional studies. This study represents the most robust characterization of XLA in Colombia, providing key data to improve clinical suspicion and prognosis.
Purpose To compare the efficacy of 3 corticosteroid delivery methods and assess whether extending treatment duration enhances patient outcomes. Methods This prospective randomized controlled trial enrolled 138 patients with chronic rhinosinusitis with nasal polyps (CRSwNP) from FA Hospital between September 2019 and February 2025. Patients were randomly allocated to 3 groups receiving a two-week regimen: Nasal Spray (budesonide nasal spray 256 μg/day), Nasal Drop (budesonide nasal spray 256 μg/day & budesonide nasal drop 1 mg/day) and Oral Steroids (budesonide nasal spray 256 μg/day & oral prednisone 30 mg/day). Visual-analogue scale (VAS), the 22-item Sinonasal Outcome Test (SNOT-22), and nasal polyps endoscopic scores (NP scores) were assessed pre- and post-treatment. The two-week data were compared to one-week time points from separate cohorts in our prior work. Results Compared to baseline (Day 0), the nasal drop group showed significantly greater VAS reduction than the nasal spray group after 2 weeks (P = 0.02), particularly in nasal obstruction (P = 0.04) and purulent rhinorrhea (P < 0.01), and was comparable to the oral group (P = 0.96). Regarding SNOT-22, the nasal drop group demonstrated superior improvement in extranasal (P = 0.02) and sleep disorder symptoms (P = 0.03) compared to the nasal spray group from baseline to 2 weeks, with no significant difference versus the oral group (P = 0.48). Additionally, the 2 weeks use of oral corticosteroids was associated with notable polyp size reduction (P = 0.02), especially in type-2 CRSwNP (P = 0.01). Extending treatment duration from 1 to 2 weeks yielded significant subjective improvements in the nasal drop group (P = 0.04), and significant endoscopic improvement only in the nasal spray group (P < 0.01). Conclusions Adding intranasal drops to nasal spray enhances short-term symptom relief, whereas oral steroids reduce polyp size more effectively, particularly in type 2 CRS.
Background Epidemiological studies have documented an association between allergic rhinitis (AR) and depression (DE), but causal interpretation is limited by confounding and reverse causation. We applied bidirectional two-sample Mendelian randomization to assess the direction and magnitude of this association and to explore candidate pathways. Methods Summary-level data were obtained separately from 2 AR GWAS (Study AR1: n = 112 583; Study AR2: n = 83 529) and 2 DE GWAS (Study DE1: n = 484 598; Study DE2: n = 462 933) of European ancestry. Independent single-nucleotide polymorphisms (P < 5 × 10−8; LD r2 < 0.001) served as instruments. Forward and reverse estimates were derived using inverse-variance weighted MR, with MR-Egger and weighted median analyses for sensitivity. A two-step framework estimated separate indirect effects through sleep duration (SD) and anxiety symptoms (ANX). Multivariable MR simultaneously modeled AR and 8 additional traits—dynamic activity ratio, light-intensity physical activity, moderate-to-vigorous activity, loneliness (LON), neuroticism (NEU), immunoglobulin E (IgE), interleukin-6, and fasting insulin—to estimate conditional effects. Pleiotropy and heterogeneity were assessed using MR-Egger intercepts, Cochran’s Q and MR-PRESSO. Results Across 2 AR instrument sets and 2 depression outcomes, genetic liability to AR was consistently associated with a small increase in depression risk (IVW ORs 1.0105–1.0125), whereas reverse-direction analyses provided no evidence that depression liability increased AR risk. AR liability was nominally associated with sleep duration (β = 0.079; 95% CI 0.005–0.153; P = 0.036) and anxiety symptoms (β = 0.031; 95% CI 0.004–0.058; P = 0.025), and was more strongly associated with total IgE (β = 1.981; 95% CI 1.200–2.762; P = 6.60 × 10−7). The separate indirect effects through sleep duration (β = 0.005; 95% CI −0.021 to 0.031; descriptive proportion 47.7%) and anxiety (β = 0.003; 95% CI −0.012 to 0.018; descriptive proportion 24.2%) were imprecise and were not combined. In MVMR, loneliness showed the strongest positive conditional association with depression (OR = 1.243; 95% CI 1.165–1.325; P = 3.40 × 10−11), whereas the conditional AR and IgE estimates were null. Because conditional instrument strength was unavailable, MVMR findings were interpreted as supportive pathway evidence. Conclusions Genetic liability to AR was consistently associated with a small increase in depression risk across 4 dataset pairings. Although the magnitude alone is insufficient to support individual-level clinical decision-making, the concordant findings add etiological evidence for an AR–depression relationship. Sleep duration and anxiety remain plausible but unconfirmed candidate pathways, while the MVMR findings prioritize loneliness for further validation. Total IgE was more consistent with an AR-related biomarker than an independent mediator.
Background: There is a growing interest in plant-based diets (PBDs) owing to their health benefits and environmental sustainability. However, plant proteins commonly consumed in PBDs are recognized allergens and are known triggers of food-induced anaphylaxis (FIA). Aim: To characterize the clinical phenotypes of FIA due to plant allergens relevant to PBDs (“PAs”) reported to the Allergy-Vigilance Network in adolescents and adults. Methods: Anaphylaxis cases attributed to plant allergens in individuals ≥13 years of age were retrospectively analyzed (2002–2024). Cases were identified by culprit allergen, irrespective of dietary patterns, and assessed for time trends, eliciting dose, cofactors, and component-resolved diagnostics. Age-specific phenotypes were compared between adolescents and adults. Results: 753 plant allergen-related FIA cases were recorded, 237 (31.5%) occurred in adolescents and 516 (68.5%) in adults. Eleven allergens (wheat, peanut, buckwheat, soy, hazelnut, sesame, lupin, cashew, pine nut, walnut and almond) accounted for 85% of all PBD-related FIA. Wheat was the main elicitor in adults (26.9% adults vs 7.6% adolescents; P < 0.001). Peanut predominated in adolescents (34.2% adolescents vs 8.1% adults; P < 0.001), and was associated with pre-existing peanut-allergy (71.8% adolescents vs 46.2% adults; P = 0.012). Soy cases in adults were frequently associated with birch pollen allergy (18.8% adolescents vs 64.5% adults; P = 0.005), whereas soy-related FIA cases in adolescents occurred in the context of a prior legume-allergy diagnosis (50% adolescents vs 5.6% adults; P < 0.001). In adolescents, physical exercise was the main cofactor reported, whereas adults showed a wider range including physical exercise, alcohol, and medications. Conclusion: Several plant allergens displayed distinct age-specific clinical phenotypes, which may be relevant for dietary counseling in food-allergic or atopic individuals considering adoption of PBDs.
Background:Seasonal allergic rhinitis (SAR) imposes a substantial disease burden worldwide. In Northern China, Artemisia pollen is the dominant autumn allergen, and many patients with moderate-to-severe SAR remain inadequately controlled despite intranasal corticosteroids and antihistamines. Stapokibart, an IL-4Rα-blocking monoclonal antibody, has shown efficacy in randomized trials, but real-world evidence and season-oriented treatment strategies remain limited. We evaluated the effectiveness and safety of Stapokibart and explored the feasibility of a short-course, season-oriented biologic strategy in SAR. Methods:This multicenter observational case series included 37 adults with Artemisia-driven SAR uncontrolled by standard therapy between August and December 2025. Patients received Stapokibart 600 mg at baseline, followed by 300 mg at week 2. Clinical outcomes, including Total Nasal Symptom Score (TNSS), VAS-Nose, VAS-Ophthalmic, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Medication Score, were assessed at baseline and weeks 1, 2, 4, 6, 12, and 16. Peripheral eosinophils, total IgE, and fractional nasal Nitric Oxide at a flow rate of 10 mL/(FnNO10) were measured at baseline, week 4, and week 16. Safety was monitored throughout follow-up. Results:Stapokibart produced rapid and sustained symptom improvement. TNSS decreased from 9.22 ± 1.11 at baseline to 2.87 ± 1.32 at week 1 and 0.97 ± 0.83 at week 4, remaining low through week 16 (0.19 ± 0.40). Similar improvements were observed in VAS and RQLQ scores, accompanied by a marked reduction in medication use. FnNO10 decreased significantly by week 4 and remained suppressed at week 16, whereas total IgE showed no significant change. No serious adverse events occurred. Conclusions:A two-dose, season-oriented Stapokibart regimen achieved rapid and durable symptom control with favorable safety in real-world SAR. This pragmatic strategy may represent a practical biologic approach aligned with seasonal disease dynamics.
Objective We aimed to investigate the associations of the daily mean and short-term variation in ambient relative humidity (RH), temperature, and fine particulate matter (PM2.5) with asthma treatment steps. Methods We consecutively recruited 288 newly diagnosed adult patients with asthma and followed them for at least 6 months according to the Global Initiative for Asthma (GINA) strategy. Odds ratios (ORs) for higher GINA treatment steps required to achieve asthma control were estimated using logistic regression. We also conducted exposure-response analyses to explore potentially nonlinear relationships between environmental exposure and asthma treatment step across seasons. Results A 1% increase in the 1-day RH difference and a 1-μg/m3 increase in the 7-day PM2.5 difference were associated with 1.054-fold and 1.052-fold higher odds of step 4 treatment, respectively. A 1% increase in the 1-day RH difference and a 1-μg/m3 increase in the 7-day PM2.5 difference were associated with 1.047-fold and 1.056-fold higher odds of medium-dose inhaled corticosteroids plus long-acting beta-agonists (ICS + LABA), respectively. A 1% increase in the 7-day RH mean and a 1-μg/m3 increase in the 30-day PM2.5 difference were associated with 1.075-fold and 1.205-fold higher odds of triple inhaler therapy and biologics use, respectively. Exposure-response analyses suggested noticeable seasonal patterns for temperature and RH in relation to asthma treatment strategy. Conclusions Our exploratory and hypothesis-generating findings showed that greater short-term variation in RH and PM2.5 was associated with higher treatment intensity in adult asthma, particularly the use of medium-dose ICS + LABA and biologics. Higher RH mean was also associated with triple inhaler therapy. These associations were more evident during the cold season. Multicenter validation studies in larger population studies are warranted.
The recent ARIA-MeDALL hypothesis proposed in 2023 that allergic rhinitis (AR) alone and allergic rhinitis and asthma (A) multimorbidity (AR + A) represent 2 distinct diseases. To improve the knowledge on this topic, we have gathered data from real-world studies using MASK-air®. According to our analyses: (i) An “extreme allergy phenotype” [A + AR + C, Conjunctivitis] was confirmed and found to be more severe (symptoms and work productivity) than single diseases alone. (ii) Patients with AR + A required more rhinitis medications, and had more severe VAS levels for nasal and ocular symptoms than those with AR alone in all countries tested. (iii) In clusters with poorly controlled AR, the frequency of co-medicating with more than 1 rhinitis drug was higher in AR + A than in AR alone. (iv) In the CONSTANCES general population cohort, a co-medication pattern (intranasal corticosteroid and oral H1-antihistamines) was associated with the presence of AR + A (vs AR alone). This co-medication pattern was associated in MASK-air® with a poorer AR control than monotherapy. (v) Patients with AR + A had different EQ-5D patterns than those with AR alone. (vi) Large differences were found between AR alone and AR + A in work impairment, resulting in higher weekly indirect costs in all OECD countries in AR + A by comparison to AR alone. Although mHealth studies are hypothesis-generating, and usually not reliable for testing or confirming hypotheses, our results are strongly in support of the nosologic distinction between A + AR and AR alone.
Background Asthma is the most common chronic disease in childhood and although many children with asthma achieve disease control with low- to medium-dose inhaled corticosteroids, 2-10% have severe asthma (SA). Biologics have been available for treatment in adults and adolescents for almost twenty years, and currently 5 biologic therapies have been approved by regulatory agencies for SA in children and/or adolescents. Objective To describe the evolution and remission rate of pediatric SA patients on biologics, including after switch of biologic. Methods A retrospective observational study was conducted January 2023 to January 2024 in SA children (6-18 years) in a tertiary care hospital. American Thoracic Society/European Respiratory Society (ATS/ERS) criteria classified asthma as severe. Patients who started biologic therapy, or who switched from a previous biologic, were included. Index date is the timepoint at which biologic therapy was started or switched. We compare clinical and biomarker (fractional exhaled nitric oxide, blood eosinophil count [BEC], IgE) data from 12 months pre- with 12 months postindex- date. Results Sixty children were included (mean age 14.1 ± 3.2 years); 34/60 (56%) female. Our 46 biologic-naïve patients received omalizumab in 21/46 (46%), dupilumab in 23/46 (50%), and mepolizumab in 2 (4%). Fourteen switchers (23%), who presented incomplete improvement on their first biologic, were changed to a second/third biologic including benralizumab and tezepelumab. Our children experienced an average of 2.4 severe exacerbations 12 months pre-index date. Twelve months post-index-date, no child experienced severe exacerbations and 98% (59/60) reached complete, 4- parameter, clinical remission plus a significant reduction of all biomarkers. Conclusion The use of biologic therapies in pediatric patients with SA allowed for adequate disease control. With correct biologic selection or timely switch when incomplete response, clinical remission, normalization of lung function and a reduction in ICS daily dose was achieved in a very high percentage. Moreover, controlling asthma enables allergen-specific immunotherapy for children with allergic SA.
Background: The Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) recently convened an expert consultation to address the increasing but inconsistent use of Precautionary Allergen (“may contain”) Labelling (PAL). Objectives: We conducted a Delphi study to explore the perspectives of clinicians, patient representatives, and other interest-holders on PAL practice. Methods: We followed previous guidance on Delphi study development and reporting. A narrative review exploring the FAO/WHO Expert Consultation informed the Delphi process. The working group generated 35 items based on the review of FAO/WHO consultation, categorized into 7 domains: (i) Importance of the issue, (ii) Informing use of PAL, (iii) Action level cut-offs, (iv) Communication, (v) Liability considerations, (vi) Free From statements, and (vii) Areas for further research. Items underwent 3 iterative Delphi rounds involving a panel of 35 experts who rated their agreement narratively and on a 5-point Likert scale. Consensus was defined as ≥70% consistency in agreement or disagreement (excluding neutral responses); stability was defined as <10% variation in average scores across rounds. A public consultation was held to collect different viewpoints arising from the consensus activity. Results: The Delphi was concluded after 3 rounds with consensus achieved for 33/35 items. Response rate was 100% across all 3 rounds. The panel strongly agreed that PAL should only be applied when an unintended allergen may be present above a cut-off (action level) and that it should always be based on a formal risk assessment, preferably quantitative, and mandated through legislation. Furthermore, action levels should be based on “reference doses” (amount of total allergenic protein), rather than on a concentration (eg, 10 ppm), and more specifically on population-adjusted eliciting doses ED05 (amount of allergen expected to elicit an objective reaction in no more than 5% of the allergic population). To achieve a balance between protection and the risk of PAL overuse, ED05 was deemed preferable to ED01. There was 70% agreement that consumers should be informed of residual risk (ie, unintended allergen presence below the reference dose), but no consensus as to how this might be done. Finally, PAL should not be used for an allergen declared to be absent with a “free from” statement, nor should a PAL appear for an allergen listed as an ingredient. Conclusions: This Delphi explored a comprehensive set of statements across multiple aspects of PAL development, application, and communication. On the one hand, it provides systematically derived considerations, aligned with the FAO/WHO consultation recommendations, to support future harmonization of practices. On the other, it highlights several areas of uncertainty to prioritize for future research.
Background: Anaphylaxis is a potentially life-threatening allergic reaction requiring prompt recognition and treatment. Although increasing trends in pediatric anaphylaxis have been reported worldwide, nationwide epidemiological data from Southeast Asia remain limited. This study aimed to investigate the epidemiology, clinical characteristics, and healthcare burden of pediatric anaphylaxis in Thailand using a national administrative database. Methods: We conducted a nationwide retrospective study using the Thai National Health Security Office database from 2019 to 2023. Children aged 1 month to <18 years hospitalized with anaphylaxis were identified using ICD-10-TM codes. Demographic characteristics, triggers, comorbidities, complications, and outcomes were analyzed. Temporal trends, regional variation, and factors associated with in-hospital mortality were evaluated. Results: A total of 42,290 pediatric anaphylaxis hospitalizations were identified, increasing from 7877 cases in 2019 to 10,519 in 2023. School-aged children and adolescents accounted for the largest proportion, with male predominance (59.4%). Food-related reactions were more common in younger children, whereas insect-related reactions were more frequent in older age groups. Most patients had favorable outcomes, with a median hospital stay of 1 day and in-hospital mortality of 0.04%. Severe complications and certain comorbidities were associated with increased risk of adverse outcomes. Geographic variation was observed across regions. Conclusions: Pediatric anaphylaxis hospitalizations in Thailand increased during the study period, while mortality remained low. Age-related trigger patterns and regional differences highlight the need for improved surveillance, documentation, and targeted prevention strategies.
