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Background: Few studies have investigated optimal storage conditions or expiration dates for sublingual immunotherapy (SLIT) formulations prepared from glycerinated allergen extracts. Hypothesis/Objectives: The objective of this study was to compare concentrations of short ragweed major allergen (Amb a 1) and total protein in SLIT formulations stored at two different temperatures. It was hypothesised that protein concentrations would show greater decline over time in a formulation stored at room temperature (RT) than in one stored under refrigeration. Materials and Methods: Two SLIT samples containing equal volumes of 20,000 PNU Amb a 1 extract were prepared and stored at refrigerated cold (CT) (2–8°C) or RT (20–24°C) for 140 days. Changes in total protein and major allergen concentration and composition were measured by Bradford assay, two‐site enzyme‐linked immunosorbent assay and SDS–PAGE. Presence of Amb a 1 was confirmed with Western immunoblot. Data were analysed using an analysis of covariance, with p < 0.05 considered significant. Results: SDS–PAGE showed compositional changes in a ~26–30 kDa protein band under RT and not CT storage. The Amb a 1 concentration of the RT SLIT sample declined significantly over time, compared to that of the CT SLIT sample (F(1,8) = 47.69, p < 0.0001). There was no significant difference in total protein concentration over time between groups (F(1,8) = 1.79, p = 0.22). Conclusions and Clinical Relevance: These results demonstrate that storage of glycerinated SLIT formulations in refrigerated CT preserved the highest concentration of the specific allergen Amb a 1, suggesting that SLIT formulations containing short ragweed should be stored under refrigeration. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to investigate the efficacy and safety of coseasonal initiation of Artemisia annua sublingual immunotherapy (SLIT) for children and adult patients with allergic rhinoconjunctivitis (ARC). Methods: A total of 50 patients (aged 4–60 years) with ARC who visited hospital from July to September 2022 were enrolled and randomly divided into the SLIT (n = 25) and control group (n = 25). Patients in SLIT group received Artemisia annua SLIT and patients in control group only received symptomatic medication. The study continued for 1 year. Four nasal symptom scores, two eye symptom scores, and medication usage of the patients during 2021 (baseline) and 2023 pollen seasons were recorded, as well as adverse events (AEs) during the study. Results: Finally, 20 patients of SLIT group and 22 patients of control group completed this study. Compared with the baseline, the levels of total rhinoconjunctivitis symptom score (TRSS), total medication score (TMS), and combined symptom and medication score for rhinoconjunctivitis (CSMS-RC) experienced significant reductions after 1 year SLIT. Additionally, these outcomes also decreased significantly in SLIT group when compared with the control group during 2023 pollen season. Especially, there were more patients showed symptoms reduction, medication use decrease, and efficacy improvement in the SLIT group. Notably, no severe AEs were observed throughout the treatment course among patients receiving SLIT. Conclusions: Coseasonal initiating Artemisia annua SLIT demonstrated clinical efficacy and safety for children and adult patients with ARC. [ABSTRACT FROM AUTHOR]

The document discusses the technical validation of controlled exposure to cat dander in the Specialized Particulate Control Environmental Exposure Unit (SPaC-EEU) located in Kingston, Canada. The SPaC-EEU, a micro-controlled room within the Environmental Exposure Unit, has been successfully validated for use with house dust mites and now cat dander. The study utilized specialized equipment to distribute cat allergen consistently throughout the facility, with the Laser Particle Counter (LPC) proving to be an effective method for real-time monitoring of Fel d 1 concentrations. This validation paves the way for future clinical studies with human participants in the SPaC-EEU. [Extracted from the article]

Introduction: In Japan, telemedicine has gradually expanded due to deregulation in response to the COVID-19 pandemic. However, its current status remains unclear, as it is primarily provided by general practitioners. This study aims to examine the use of telemedicine in sublingual immunotherapy (SLIT) for patients with Japanese cedar pollen allergy and/or house dust mite allergic rhinitis. Methods: We conducted a retrospective analysis of medical record data from seven otorhinolaryngology clinics and performed an exploratory evaluation between a group that combined telemedicine and in-person visits during the initial 6 months of SLIT and another group with only in-person visits. Results: Following propensity score matching, 51 and 82 patients were eligible for the telemedicine and in-person groups, respectively, with 33 cases in both groups. Both groups had similar characteristics after matching. No significant difference was found in the withdrawal rate at 6 months from the start of SLIT (6.1% and 9.1% in each group; p = 1.00), side effects, or treatment efficacy between the two groups. The average copayment for patients tended to be significantly higher in the telemedicine group after one, three, and 6 months following SLIT initiation. Discussion: The situation of patients who receive an appropriate combination of telemedicine and in-person visits is not significantly different from patients who receive in-person visits alone. This study may help indicate the actual status of telemedicine in Japan. Further investigation at more facilities is necessary in the future to dispel concerns in the practice setting. [ABSTRACT FROM AUTHOR]

Objective: Asthma is a common chronic condition in children globally. Allergen-specific immunotherapy, such as subcutaneous (SCIT) and sublingual (SLIT) therapies, are promising by increasing allergen tolerance. This meta-analysis compares the efficacy and safety of SLIT and SCIT in pediatric asthma. Methods: We searched PubMed, Cochrane Library, and Embase for randomized controlled trials and case–control studies comparing SLIT and SCIT in asthmatic children. Meta-analysis was conducted using random-effects models with calculations via R software version 4.3.2 and RevMan version 5.4. Study quality and bias risk were assessed using the Newcastle-Ottawa Scale and Cochrane Risk of Bias Tool. Results: The literature search yielded a total of 1787 records, with 7 studies meeting the inclusion criteria after screening and assessments. There was no significant difference in the Total Asthma Symptoms Score between SLIT and SCIT (mean difference −0.05 [95% CI: −0.21; 0.10]). However, asthma improvement rates were higher in the SLIT group (risk ratio 0.77 [95% CI: 0.64; 0.93]). FEV1 improvement showed no significant difference (mean difference −1.60 [95% CI: −6.27; 3.08]). Adverse events were similar between the treatments (risk ratio 0.56 [95% CI: 0.11; 2.82]). Conclusions: SLIT and SCIT were generally similarly effective and safe for treating pediatric asthma. SLIT may be preferred due to its noninvasive administration. More research is needed on long-term effects and tailored treatment approaches. [ABSTRACT FROM AUTHOR]

Background: Standardized quality (SQ) house-dust mite (HDM) sublingual immunotherapy tablets (10,000 Japanese allergy units [JAU], equivalent to 6 SQ-HDM in Europe and the United States) are licensed for the treatment of HDMinduced allergic rhinitis (AR) without age restriction, based on 52-week administration clinical trials. There are no large-scale data on the administration of 10,000 JAU for > 1 year in actual clinical practice. Objective: To examine the safety and effectiveness of 10,000 JAU during use for up to 3 years at real-world clinical sites in Japan. Methods: This survey was a multicenter, observational, prospective study. We assessed the safety and effectiveness of the long-term administration of 10,000 JAU as well as effectiveness after its discontinuation in patients with HDM AR with an observation period of 3 years. Results: The safety analysis included 815 patients, and the effectiveness analysis included 768 patients. Adverse reactions that occurred in 144 patients (17.67%) were mainly site-related events that occurred early in the dosing period. Serious adverse reactions were dyspnea and anaphylactic reaction in one patient each, and both patients recovered. With regard to effectiveness, compared with scores before the administration of SQ-HDM, nasal symptom scores decreased, depending on the administration period, from 6 months to 3 years. Overall, 67.34% of the patients had improved quality of life after 6 months, and this improvement continued after 12 months. The proportion of patients with "improved and slightly improved" of overall improvement exceeded 90% after 2 years. Treatment discontinuation because "symptoms disappeared" occurred in 24.42% of the patients at 3 years. Patients who discontinued 10,000 JAU (n = 39) had a sustained improvement in nasal symptom scores compared with baseline, even 1 year after discontinuing treatment. Conclusion: The real-world safety and effectiveness of 10,000 JAU SQ-HDM sublingual immunotherapy tablets were confirmed in Japanese patients with HDM AR. No new safety and effectiveness precautions were required. [ABSTRACT FROM AUTHOR]

Introduction: Allergen-specific immunotherapy (AIT) induces long-term immune tolerance to allergens and is effective for treating allergic rhinitis (AR). However, the impact of sublingual immunotherapy (SLIT) on gut microbiota from AR patients and its correlation with treatment efficacy remains unclear. Methods: In the present study, we enrolled 24 AR patients sensitized to Dermatophagoides farinae (Der-f) and 6 healthy donors (HD). All AR patients received SLIT treatment using standardized Der-f drops. Stool samples were collected from AR patients before treatment, and 1- and 3-months post-treatment, as well as from HD, for metagenomic sequencing analysis. Results: AR patients had significantly lower richness and diversity in gut microbiota compared to HD, with notable alterations in composition and function. Besides, three months post-SLIT treatment, significant changes in gut microbiota composition at the genus and species levels were observed in AR patients. Streptococcus parasanguinis_B and Streptococcus parasanguinis , which were significantly lower in AR patients compared to HD, increased notably after three months of treatment. LEfSe analysis identified these species as markers distinguishing HD from AR patients and AR patients pre- from post-SLIT treatment. Furthermore, changes in the relative abundance of S. parasanguinis_B were negatively correlated with changes in VAS scores but positively correlated with changes in RCAT scores, suggesting a positive correlation with effective SLIT treatment. Discussion: SLIT treatment significantly alters the gut microbiota of AR patients, with S. parasanguinis_B potentially linked to its effectiveness. This study offers insights into SLIT mechanisms and suggests that specific strains may serve as biomarkers for predicting SLIT efficacy and as modulators for improving SLIT efficacy. [ABSTRACT FROM AUTHOR]

Background: Sublingual immunotherapy (SLIT) has shown promise in mitigating allergic asthma symptoms; nevertheless, its high dose and prolonged duration of treatment raise safety concerns. This study explored the potential of Lactobacillus paracasei (L. paracasei) to enhance the effectiveness of SLIT in a mouse model of allergic asthma. Methods: Allergic asthma was induced in Balb/c mice following sensitization and challenge with a house dust mite (HDM) allergen. Subsequently, the mice were subjected to SLIT (66 and 132 µg) either alone or in combination with L. paracasei supplementation. Asthma-associated parameters, including rubbing frequency, IgE level, cytokine profiles, and histological changes, were evaluated to assess treatment efficacy. Results: mice that received SLIT 132 µg combined with the probiotic (combined 132) demonstrated a significant reduction in allergic symptoms (rubbing). This treatment strategy led to a marked IgE and eosinophil level decrease in serum; an increase in anti-inflammatory cytokines like IFN-γ and IL-10; and a reduction in pro-inflammatory cytokines IL-17 and TNF-α. The combination therapy also mitigated lung inflammation and supported the restoration of the structural integrity of the colon, promoting the recovery of goblet cells and mucus secretion. Probiotic treatment alone also effectively reduced IgE levels, increased IFN-γ, and decreased levels of IL-17 and TNF-α. Conclusions: The adjuvant effect of L. paracasei in enhancing SLIT represents a promising approach for improving asthma treatment efficacy. [ABSTRACT FROM AUTHOR]

In the past decades, food allergies became increasingly dominant since early childhood, leading to a lower quality of life and to increasing costs addressed by the health care system. Beside standard avoidance of specific allergens and drug treatments following allergen exposure, a great deal of research has lately focused on Food Allergy Allergen Immunotherapy (FA‐AIT). SCIT and EPIT (Subcutaneous and Epicutaneous Immunotherapy), OIT (Oral Immunotherapy), and SLIT (Sublingual Immunotherapy) consist in gradual exposure to allergens to desensitize and achieve tolerance once therapy has ended. Although promising, FA‐AIT may bring acute local and systemic adverse reactions. To enhance efficacy, safety and convenience of AIT, the quest of potential adjuvants to mitigate the adverse reactions becomes crucial. Immunomodulatory activities, such as that of increasing the regulatory T cells and decreasing the IgE, have been observed in specific probiotics' strains and multiple studies elucidated the role of gut microbiota as a major interplayer among the host and its immune system. In this review, the microbiome modulation is shown as potential AIT adjuvant, nevertheless the need of more clinical studies in the near future is pivotal to assess the efficacy of targeted bacterial therapies and faecal microbiota transplantation. [ABSTRACT FROM AUTHOR]

Objective: One of the most effective treatments for allergic respiratory diseases is allergen-specific sublingual immunotherapy (SLIT). While, mannose targeting has been applied in various immunostimulatory approaches, but it has not been investigated in sublingual allergen-specific immunosuppressive treatment. This study assesses mannose targeting for the ovalbumin (Ova) loaded poly(lactic-co-glycolic acid) (PLGA) nanoparticles(NPs). Methods: The emulsion-solvent evaporation method was employed for the synthesis of PLGA NPs containing Ova, and subsequently they attached to D-mannose. Ova-sensitized mice underwent treatment in different ways: subcutaneous administration of 10 µg Ova, sublingual administration of 5 and 10 µg Ova loaded in PLGA NPs, 5 and 10 µg Ova loaded in mannose-targeted PLGA NPs, 10 µg Ova, and 10 µg Ova loaded in dendritic cell-specific aptamer-attached PLGA NPs. Serum Ova-specific IgE and IgG2a levels, as well as IFN-γ, IL-4, IL-10, and IL-17a levels in the supernatant of Ova-stimulated splenocytes were measured. Splenocyte proliferation was assessed using an MTT assay, and also lung histological examinations, and nasal lavage fluid cell counting were performed. Results: Ova-specific IgE, IL-4, IL-17a levels, eosinophil cell count, and splenocyte proliferation were remarkably reduced in the mice treated with mannose or aptamer targeted NPs compared to other groups. Also, IL-10 and IFN-γ levels were remarkably increased in the targeted NPs groups. Conclusion: Our findings indicated that mannose targeting of PLGA NPs could decrease allergen dose and improve immunomodulatory effects of SLIT. However, this approach suggests an effective formulation for SLIT in the mice model, further studies with common allergens are needed for application in humans. [ABSTRACT FROM AUTHOR]

Allergen vulnerability is highly individual specific. House dust mites (HDMs) are major sources of airborne allergens, found not only in houses but also detected in workplaces and most schools. The two most common HDM species from the Pyroglyphidae family, namely Dermatophagoides pteronyssinus and Dermatophagoides farinae are responsible for 90% of sensitization and allergic symptoms. Clinical conditions due to HDM allergen are rhinitis, conjunctivitis, asthma and/or atopic dermatitis (AD), and rare severe systemic reaction. Accurate diagnosis by skin prick test, specific immunoglobulin E (extract and component-based), or nasal provocation test with standardized HDM extract in contest with clinically relevant exposure to dust mites is fundamental for successful treatment. Allergen immunotherapy (AIT) is the only treatment providing sustained efficacy for moderate-to-severe allergic rhinitis, allergic asthma, and AD. This review will mainly focus on the description of HDM allergens, immunology, efficacy, and HDM-AIT (subcutaneous immunotherapy and sublingual immunotherapy).

Allergic conjunctivitis is the most common type of allergic eye disease, and the incidence in children and adolescents is increasing year by year. Drug therapy can only relieve some symptoms and only in a short period, while allergen immunotherapy is currently a therapy that can significantly improve the symptoms of chronic allergy and the course of the disease. This method has been used abroad for many years but has yet to be reported in China. The author reviews the effective mechanism and clinical efficiency of allergen immunotherapy and provides a reference for the further clinical application in China.

Allergen immunotherapy (AIT), including SCIT and SLIT, is a treatment that involves the administration of allergens to which patients with allergic diseases have been sensitized. HDM-SCIT for asthma is indicated in cases of HDM-sensitized allergic asthma with normal lung function. HDM-SCIT improves asthma symptoms and AHR, and decreases the medication dose. Importantly, AIT can improve other allergic diseases complicated by asthma, such as allergic rhinitis, which can also contribute to the improvement of asthma symptoms. Several studies have suggested that HDM-SLIT also attenuates the risk of asthma exacerbations, and improves lung function in asthma cases with allergic rhinitis. Furthermore, AIT can modify the natural course of allergic diseases, including asthma. For example, the effects of AIT are maintained for at least several years after treatment discontinuation. AIT can prevent the onset of asthma when introduced in allergic rhinitis, and can also inhibit or reduce new allergen sensitizations. Recent data have suggested that AIT may suppress non-targeted allergen-induced immune responses in addition to targeted allergen-induced responses, and suppress infections of the lower respiratory tract by enhancing IFN responses.

Background Methods Results Conclusion Allergic rhinitis and/or conjunctivitis (AR/C) induced by tree pollen is common and negatively impacts quality of life in children and adolescents. This phase III trial investigated the efficacy and safety of the SQ tree SLIT‐tablet in a paediatric population (5–17 years) with moderate‐to‐severe AR/C induced by pollen from birch and trees in the birch homologous group.Nine hundred and fifty‐two subjects were randomized (1:1) to daily treatment with SQ tree SLIT‐tablet or placebo for up to 52 weeks and had free access to AR/C symptom‐relieving medications. The primary endpoint was the average total combined score (TCS); sum of average daily symptom score (DSS) and average daily medication score (DMS) during the birch pollen season (BPS). Key secondary endpoints included average DSS and DMS during BPS and average TCS, DSS and DMS during tree pollen season (TPS).SQ tree SLIT‐tablet demonstrated a statistically significant and clinically relevant treatment effect compared with placebo for the TCS during BPS with an absolute treatment difference of 1.29 (95% CI: 0.58, 2.00; p = .0004) and a relative reduction of 21.9% (95% CI: 10.6, 31.9). Results were substantiated by reductions in both DSS and DMS versus placebo during the BPS and in DSS, DMS and TCS during the TPS. Treatment was generally well tolerated. Most treatment‐related adverse events were mild or moderate local administration site reactions.This is the first paediatric trial to provide robust evidence of efficacy and safety of the SQ tree SLIT‐tablet in tree pollen‐induced AR/C in a paediatric population (5–17 years). [ABSTRACT FROM AUTHOR]

Background: Allergy immunotherapy (AIT), a treatment approach for allergic rhinitis (AR), is recognized for its potential to modify the disease course beyond mere symptom relief. Interleukin‐36γ (IL‐36γ), a key player in immune responses, has been implicated in promoting eosinophilic inflammation in AR by activating eosinophils. We aimed to investigate the effect of IL‐36γ on group II lymphoid cell (ILC2) in AR patients who underwent sublingual immunotherapy (SLIT). Methods: Twenty‐four AR patients were enrolled and administered with SLIT. Serum proteins of IL‐36γ, interleukin‐5 (IL‐5), and interleukin‐13 (IL‐13) during SLIT were quantitatively assessed using enzyme‐linked immunosorbent assay (ELISA). The proportion of ILC2 was determined by flow cytometry. Sorted ILC2s were stimulated by IL‐36γ and ILC2 cell differentiation, and type II cytokines expression were examined. Results: SLIT treatment decreased the serum protein levels of IL‐36γ, IL‐5, IL‐13, and the proportion of ILC2 significantly. IL‐36γ suppressed the proliferation of ILC2 by inhibiting the levels of ILC2 transcription factor. IL‐36γ also inhibited IL‐5 and IL‐13 expression from ILC2. Conclusion: The changes of IL‐36γ during SLIT were related to the inhibited function of ILC2, implying that IL‐36γ may be used as a new biomarker for monitoring the efficacy of SLIT in AR. [ABSTRACT FROM AUTHOR]

Sublingual immunotherapy (SLIT) has received considerable attention as a method for allergen immunotherapy (AIT). However, the mechanism of SLIT, especially its timing, has not been thoroughly investigated. We evaluated therapeutic and prophylactic SLIT in an allergic airway inflammation model and evaluated their efficacies. Mice were intranasally exposed to Dermatophagoides farinae (Der f) extract and received SLIT before (prophylactic model) and after (therapeutic model) intranasal exposure of Der f. We investigated airway responsiveness, airway inflammation, allergen-specific antibodies, lung histology and single-cell RNA sequencing (scRNA-seq) and T-cell receptor sequencing were also investigated. SLIT in the therapeutic model was effective; however, the effects of SLIT in the prophylactic model were stronger and immune tolerance was maintained for three months. ScRNA-seq of lung CD4+CD25+ T cells revealed that the expansion of induced T regulatory (iTreg) cells was greater in the prophylactic model than that in the therapeutic model. Additionally, the TCR repertoire of iTregs from the prophylactic model was abundant, sharing many clones with the TCR repertoire of effector T cells. These data suggest that the prophylactic model of AIT is extremely effective and persistent, and may respond to allergen diversity, and provide evidence for the clinical recommendation of preventive AIT. [ABSTRACT FROM AUTHOR]

Background/Objectives: Subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) are commonly used for allergic rhinitis (AR), yet limited research has directly compared their effects on quality of life (QoL). We aimed to assess QoL differences between SLIT and SCIT recipients. As both forms of immunotherapy have reported benefits, we hypothesize that patients undergoing SLIT and SCIT will have comparable QoL improvements. Methods: A cohort study included patients with AR treated with immunotherapy from 2018 to 2022. Patients with obstructive sleep apnea, primary ciliary dyskinesia, cystic fibrosis, vasculitis, rheumatoid arthritis, sarcoidosis, or lupus were excluded. QoL was evaluated using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) at multiple time points. Demographics, additional therapies, and allergen sensitivities were recorded. Data were analyzed using SPSS Statistics. Results: A total of 41 participants were eligible for inclusion. Both SLIT and SCIT groups exhibited reductions from baseline RQLQ scores. Within SLIT recipients, 5/7 RQLQ domains significantly improved. SCIT recipients showed significant QoL enhancement in 3/7 domains. The mean difference between SLIT and SCIT cohorts was −0.18 (p = 0.57, d = −0.18, 95% CI [−0.79, 0.43] at a mean treatment time of 18 months. Conclusions: SLIT and SCIT showed comparable RQLQ score reductions after 18 months of therapy, suggesting similar QoL benefits between the two treatment paradigms. Further investigation is needed to explore SLIT vs. SCIT differences in long-term QoL improvements beyond two years. [ABSTRACT FROM AUTHOR]

Background and Objectives: The medications preferred by patients for allergic rhinitis and their usage remain unclear. This study investigated treatment-seeking behaviors in patients with allergic rhinitis, including medical treatments, environmental controls, and surgical treatments. Methods: In this study, a cross-sectional survey was conducted by internal medicine, pediatric, or otorhinolaryngology physicians at university hospitals from January 2022 to April 2022. A questionnaire was administered to patients with confirmed allergic rhinitis to collect information regarding medical treatments (prescription and over-the-counter medication use patterns, comorbid asthma, and allergen-specific immunotherapy), environmental controls (usage of air purifiers and pet avoidance), and experiences with surgical treatments. Results: We included 51 patients with allergic rhinitis with a mean age of 31.6±16.0 years. Among them, 47 (92.2%) and 6 (11.8%) patients had pollen allergies and asthma, respectively. Furthermore, 41 (80.4%) patients took prescribed medicines, while 39 (76.5%) patients only used the medication when experiencing symptoms. Thirty patients (58.8%) reported concurrent use of intranasal sprays and oral medications. Thirty-three patients (64.7%) reported awareness of immunotherapy, and there were no preferential differences between subcutaneous (52%) and sublingual immunotherapy (48%). Of the 36 patients (70.6%) who reported using an air purifier, 38.9% considered it helpful in preventing allergic rhinitis symptoms. Fourteen patients (27.5%) currently or previously had a companion animal, with half experiencing worsening of symptoms. Twelve patients had received surgical treatment and reported high satisfaction levels (41.6%, very satisfied; 41.6%, satisfied). Conclusion: Patients with allergic rhinitis showed similar preferences for oral and spray medications. They also showed satisfaction with surgical treatments and an interest in the environmental management of allergic rhinitis. [ABSTRACT FROM AUTHOR]

Patients and families living with food allergy may experience significant burdens, including social isolation, impaired quality of life, and anxiety. Allergists/immunologists play a critical role in educating families living with food allergies about risk, particularly with regard to the rarity of fatal food allergy. Appropriate risk framing can greatly decrease the fear-based burden of disease. In 2024, an increasing complex fabric of food allergy treatments has emerged that includes oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and omalizumab, with the promise of additional treatments, including epicutane-ous immunotherapy and oral mucosal immunotherapy in the near future. Younger children may be most likely to benefit from OIT and SLIT, with some evidence that suggests the possibility of an immunomodulatory effect. Omalizumab, approved in 2024 for use in conjunction with strict avoidance, increases the threshold of reactivity before a moderate-to-severe reaction for many, but not all, patients. There is no evidence to date that omalizumab has an immunomodulatory effect, and young children treated with omalizumab monotherapy may bear a lost opportunity cost from possible immunomodulation would they have been treated with OIT or SLIT instead; however, within a shared decision-making paradigm, beyond label use of omalizumab may include treatment with OIT or SLIT. Fortunately, the co-evolution of shared decision-making with modern food allergy treatments will facilitate the critical preference-sensitive care that must be characteristic of all decisions surrounding active food allergy management. [ABSTRACT FROM AUTHOR]

Objective: Allergic rhinitis (AR) is a growing public health problem worldwide. Respecting the significance of the modified Lund-Kennedy (MLK) score in rhinitis assessment, we delved into its evaluation value on the sublingual immunotherapy (SLIT) efficacy in AR patients. Methods: Totally 100 AR patients were enrolled, with pre- and post-SLIT MLK score, total nasal symptoms score (TNSS), total medication score (TMS), visual analogue scale (VAS), inflammatory cytokines, and immune function-related parameters compared. The correlations of MLK score with TNSS/TMS/VAS, as well as with IL-4/INF-γ/eosinophil (EOS)/percentage/specific immunoglobulin (sIgE)/sIgG were assessed by Spearman correlation analysis. The value of MLK score on assessing SLIT efficacy in AR patients was analyzed. Results: SLIT treatment reduced MLK/TNSS/TMS/VAS scores, abated IL-4 level/EOS percentage/sIgE, and elevated INF-γ/sIgG levels. MLK score was positively correlated with pre- and post-SLIT TNSS score (rpre−treatment = 0.592, rpost−treatment = 0.756), TMS score (rpre−treatment = 0.385, rpost−treatment = 0.718), VAS score (rpre−treatment = 0.369, rpost−treatment = 0.704), IL-4 (rpre−treatment = 0.553, rpost−treatment = 0.639), EOS percentage (rpre−treatment = 0.511, rpost−treatment = 0.632), and sIgE (rpre−treatment = 0.472, rpost−treatment = 0.524), and negatively with INF-γ (rpre−treatment = −0.418, rpost−treatment = −0.578) and sIgG4 (rpre−treatment = −0.460, rpost−treatment = −0.613). The MLK score had an area under curve of 0.846 (77.01% sensitivity, 76.92% specificity, 4 cut-off value) and 0.944 (91.67% sensitivity, 92.11% specificity, 2 cut-off value) for assessing SLIT treatment as effective and markedly effective for the patients, respectively. Conclusion: The MLK score had good evaluation value on the efficacy of SLIT treatment in AR patients. [ABSTRACT FROM AUTHOR]

This European Academy of Allergy and Clinical Immunology (EAACI) guideline provides recommendations for the management of IgE‐mediated food allergy and was developed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Following the confirmation of IgE‐mediated food allergy diagnosis, allergen avoidance and dietary advice (with support of a specialised dietitian, if possible) together with the provision of a written treatment plan, education on the recognition of allergic symptoms and prescription of medication including adrenaline using an auto‐injector are essential. Patients with significant anxiety and requirement for coping strategies may benefit from support from a clinical psychologist. As immunomodulatory interventions, omalizumab is suggested for treatment of IgE‐mediated food allergy in children from the age of 1 and adults; and oral allergen‐specific immunotherapy is recommended for children and adolescents with peanut allergy and suggested for milk and egg allergies (generally after 4 years of age for milk and egg). Sublingual and epicutaneous immunotherapy are suggested for peanut allergy but are not yet available at the point of care. Future research into disease modifying treatments for IgE‐mediated food allergy are highly needed, with standardised and patient‐focused protocols and outcomes. [ABSTRACT FROM AUTHOR]

Background: This meta-analysis aimed to evaluate the effectiveness and adverse effects of specific immunotherapy (SIT) in the management of respiratory allergens, including allergic asthma, rhinitis, and related disorders, based on a review of current literature up to November 8, 2022. Methods: We conducted a search of databases, including PubMed, Embase, Cochrane, and Web of Science, to identify relevant randomized controlled trials (RCTs) assessing respiratory allergy-specific immunotherapy. We employed the Consolidated Standards of Reporting Trials (CONSORT) Statement to select RCTs that adhered to rigorous reporting standards. Specifically, we focused on double-blind placebo-controlled (DBPC) trials and open studies involving both adults and children, considering factors such as dosage, inclusion criteria, allergens, and primary outcome measurements. Results: A total of 25 meta-analyses were included in this study. Among them, 14 evaluated sublingual-specific allergen immunotherapy (SLIT), 4 assessed subcutaneous allergen immunotherapy (SCIT), 4 explored both sublingual and subcutaneous immunotherapy, and 3 investigated intralymphatic immunotherapy. The outcomes of these meta-analyses indicated a reduction in medication scores in 20 cases and a decrease in symptom scores in 23 cases. Additionally, six studies reported on changes in IgE levels, seven studies focused on IgG4, four studies examined FEV1 (forced expiratory volume in 1 s), and eight studies reported on symptom and medication scores. Furthermore, 11 studies reported on differences in adverse reactions. Conclusion: The results of our meta-analysis suggest that specific immunotherapy, while associated with some adverse effects, effectively reduces the symptoms of asthma and rhinitis. Therefore, we recommend its use in the treatment of respiratory allergies. [ABSTRACT FROM AUTHOR]

Objective To construct a nomogram prediction model for adverse reactions of mite sublingual immunotherapy (SCIT) in children with allergic asthma, and to evaluate and validate it. Methods Clinical data of children with allergic asthma who were managed by mite SCIT in Department of Pediatrics, the Second Hospital of Tianjin Medical University were retrospectively analyzed. According to the adverse reactions in the initial treatment stage of SCIT, they were divided into adverse reaction group and no adverse reaction group, which together formed the modeling group. Through univariate logistic regression analysis and multivariate logistic regression analysis, independent risk factors were screened out. Then construct the prediction model, draw a nomogram, eventually evaluate and validate the model. Results A total of 350 children were included, including 176 in the adverse reaction group and 174 in the no adverse reaction group. Univariate logistic regression analysis was performed on the baseline data of the children in the modeling group, and the results were as follows. Gender, age, number of asthma exacerbations in the past 1 year, percentage of eosinophils (EOS%), forced expiratory volume in the first second in percent predicted values (FEV1%pred), total IgE (tIgE), dermatophagoides pteronyssinus (Der p) sIgE, dermatophagoides farinae (Der p)sIgE, and the number of other inhaled allergenic species were the risk factors of SCIT-related adverse reactions (all P < 0.1). These were included in the multivariate logistic regression analysis, and the results showed that：age, the number of asthma exacerbations in the past 1 year, tIgE, Der p sIgE, Der f sIgE, and the number of other inhaled allergen species were independent risk factors (all P < 0.05). Based on the results, nomogram was drawn in R language. Model evaluation by receiver operating characteristic curve showed an area under curve of 0.877, a predictive model sensitivity of 73.9%, and a specificity of 90.8%. The predicted probability was consistent with actual probability of occurrence. The model has good prediction performance. Conclusions Age, number of asthma exacerbations in the past 1 year, tIgE, Der p sIgE, Der f sIgE, and the number of other inhaled allergen species were independent risk factors for adverse reactions to mite SCIT in children. The nomogram drawn in this study has good predictive value. [ABSTRACT FROM AUTHOR]

Curcumin (CUR) has been considered a potential therapeutic agent for allergic reactions due to its antioxidant and anti-inflammatory activities. Nanofibers have attracted increasing attention in drug delivery. The aim of this study was to investigate the combined therapeutic effects of curcumin and allergen in nanofiber-based treatments in order to increase the effectiveness of sublingual immunotherapy (SLIT) efficacy in a mouse model of allergic rhinitis. Nanofibers containing CUR (1.25% and 2.5%) and ovalbumin 2% (OVA) as an allergen were prepared via electrospinning and characterized. BALB/c mice were sensitized with OVA to the induced allergic rhinitis model. SLIT with free and/or nanofibers was carried out. IL-4, INF-γ, and IgE serum levels were measured using ELISA. Splenocyte proliferation was evaluated by the MTT assay. Lung and nasal histological examinations and nasal lavage fluid (NALF) cell counting were carried out. Nanofibers containing 1.25% CUR and 2% OVA were chosen as the optimal formulations. SLIT treatment with the CUR and OVA nanofiber co-administration led to a significantly decreased serum IgE. Nanofiber containing 2.5 µg of CUR/mouse combined with OVA nanofiber showed a significant decrease in IL-4 and an increase in IFN-γ compared to other groups. NALF assessment showed a significant decrease in specific cell and eosinophil counts in the treated nanofiber groups. The histopathological results of NAL in the optimal formulations were near normal, with diminished cellular infiltration and inflammation. Our findings suggest that co-sublingual administration of allergen and CUR nanofibers can be considered as potential immunomodulatory agents. [ABSTRACT FROM AUTHOR]

Background Methods Results Conclusion In contrast to sublingual immunotherapy (SLIT) with recombinant Mal d 1 (rMal d 1‐SLIT), SLIT with rBet v 1 (rBet v 1‐SLIT) induced Mal d 1‐cross‐reactive antibodies without IgE‐blocking activity. To elucidate whether the development of cross‐protective IgG responses depends on the degree of molecular identity of allergens we compared the cross‐reactivity, cross‐blocking activity, and affinity of SLIT‐induced antibodies with allergens of varying amino acid sequence identities to Bet v 1 and Mal d 1, namely Cor a 1.04 (hazelnut), Pru av 1 (cherry), and Dau c 1 (carrot).Allergen‐specific antibodies were quantified by ELISA. IgE blocking was analyzed by inhibition of allergen‐induced basophil activation and IgE‐facilitated allergen‐presentation to T cells. The affinity of SLIT‐induced antibodies was studied by acidic dissociation ELISA and competition ELISA. Identical surface areas on allergens were predicted using an in‐house designed script based on structural alignments.rBet v 1‐SLIT‐induced IgG antibodies cross‐reacted with all allergens except Dau c 1. rMal d 1‐SLIT‐induced antibodies predominantly cross‐reacted with Pru av 1 and displayed significantly higher IgE blocking to Pru av 1 than rBet v 1‐SLIT‐induced antibodies. rMal d 1‐SLIT‐induced IgG1 showed higher affinity to Mal d 1 and Pru av 1. Surface analysis revealed 84% identical area on Mal d 1 and Pru av 1. Furthermore, we identified two surface areas potentially containing epitopes present on these allergens and absent on Bet v 1.In summary, our findings suggest that a relatively high threshold of similarity is required to establish effective cross‐blocking antibodies to related allergens. Apparently, the structural identity between Bet v 1 and Mal d 1 is below this threshold. Therefore, this study may explain why immunotherapy with birch pollen allergen often fails to reduce birch pollen‐related apple allergy. [ABSTRACT FROM AUTHOR]

Food allergy is a growing problem with limited treatment options. It is important to understand the mechanisms of food tolerance and allergy to promote the development of directed therapies. Dendritic cells (DCs) are specialized antigen-presenting cells (APCs) that prime adaptive immune responses, such as those involved in the development of oral tolerance and food allergies. The DC subsets in the gut and skin are defined by their surface markers and function. The default response to an ingested innocuous antigen is oral tolerance, which requires either gut DCs or a subset of newly identified RORγt+ APCs to induce the development of gut peripheral regulatory T cells. However, DCs in the skin, gut, and lung can also promote allergic sensitization when they are activated under certain inflammatory conditions, such as with alarmin release or gut dysbiosis. DCs also play a role in the responses to the various modalities of food immunotherapy. Langerhans cells in the skin appear to be necessary for the response to epicutaneous immunotherapy. It will be important to determine which real-world stimuli activate the DCs that prime allergic sensitization and discover methods to selectively initiate a tolerogenic program in APCs. [ABSTRACT FROM AUTHOR]

BackgroundAllergen immunotherapy (AIT) is a well-established disease-modifying therapy for allergic rhinitis, yet the fundamental mechanisms underlying its clinical effect remain inadequately understood. Gauging Response in Allergic Rhinitis to Sublingual and Subcutaneous Immunotherapy was a randomized, double-blind, placebo-controlled trial of individuals allergic to timothy grass who received 2 years of placebo (n = 30), subcutaneous immunotherapy (SCIT) (n = 27), or sublingual immunotherapy (SLIT) (n = 27) and were then followed for 1 additional year.ObjectiveWe used yearly biospecimens from the Gauging Response in Allergic Rhinitis to Sublingual and Subcutaneous Immunotherapy study to identify molecular mechanisms of response.MethodsWe used longitudinal transcriptomic profiling of nasal brush and PBMC samples after allergen provocation to uncover airway and systemic expression pathways mediating responsiveness to AIT.Trial registrationClinicalTrials.gov Identifier: NCT01335139, EudraCT Number: 2010-023536-16.ResultsSCIT and SLIT demonstrated similar changes in gene module expression over time. In nasal samples, alterations included downregulation of pathways of mucus hypersecretion, leukocyte migration/activation, and endoplasmic reticulum stress (log2 fold changes -0.133 to -0.640, false discovery rates [FDRs]

Abstract Allergic rhinitis (AR) is a widespread health issue with a rising global prevalence, and sublingual immunotherapy (SLIT) has shown efficacy in AR treatment. We examined specific immunoglobulin G4 (sIgG4) expression in AR and its role in evaluating SLIT efficacy and predicting patient prognosis. We compared total nasal symptom score (TNSS), total medication score (TMS), visual analogue scale (VAS) score, inflammatory cytokines, and immune function markers in AR patients before and after SLIT. SLIT reduced TNSS, TMS, VAS scores, IL‐4, IL‐17, eosinophilia percentage (EOS%), and specific immunoglobulin E (sIgE) levels, while increasing INF‐γ, IL‐10, and sIgG4. The sIgG4 level at pre‐treatment and 12 months post‐treatment was negatively correlated with TNSS, TMS, VAS score, IL‐4, IL‐17, EOS%, and sIgE, and positively correlated with IFN‐γ and IL‐10. Most patients showed symptomatic improvement. After 12 months, sIgG4 level demonstrated an area under the curve (AUC) of 0.867 for assessing SLIT as effective. Pre‐treatment sIgG4 level showed an AUC of 0.869 for predicting SLIT as effective. Collectively, sIgG4 has strong potential assessing SLIT efficacy and prognosis in AR patients, with correlations to TNSS, TMS, VAS score, and IL‐4, IL‐10, IL‐17, INF‐γ, EOS% and sIgE levels.

Aim: Whether house dust mite (HDM) sublingual immunotherapy (SLIT) is effective for the skin symptoms of adult atopic dermatitis (AD) is unclear.Methods: HDM SLIT was added to conventional AD treatment for 10 HDM-sensitized AD patients with rhinitis for 2 years.Results: Seven out of ten enrolled patients completed the study. Eczema Area and Severity Index score was significantly reduced when comparing before treatment and at 24 months follow-up. CD203c ratio in the basophil activation test using HDM extract, skin prick test with HDM extract and Dermatophagoides pteronyssinus/Dermatophagoides farinae specific-IgG4 tended to improve when comparing before treatment and after treatment.Conclusion: HDM SLIT might be a therapeutic option for AD patients with rhinitis who are sensitized to HDM.

The article "Advancements in food allergen immunotherapy: improving quality of life and reducing risks" discusses the impact of pediatric food allergies on quality of life and recent research on food allergen immunotherapy. It highlights the prevalence of food allergies, the development of diverse immunotherapy approaches, and the need for personalized treatment strategies. The study emphasizes the potential benefits of various immunotherapy methods, such as oral, sublingual, and epicutaneous immunotherapy, in improving outcomes for children with food allergies and their families. The article also addresses safety concerns and the importance of selecting suitable candidates for immunotherapy to enhance treatment efficacy and quality of life. [Extracted from the article]

The aim of this review is to investigate the possible role of allergen immunotherapy (AIT) for house dust mites in the treatment of atopic dermatitis in adult patients (AD). AIT is a commonly accepted treatment for selected allergic diseases such as allergic rhinitis, bronchial asthma, allergy to venom, and sometimes food allergy. There have been a few original reports on improving AD symptoms due to subcutaneous and sublingual immunotherapy with selected allergens, mainly house dust mites. However, the precise role of immunotherapy in treating atopic dermatitis (AD) is still not clearly defined despite some studies that have been conducted. The review discusses available studies that provide evidence of the efficacy of AIT in patients with AD who are allergic to house dust mites. The authors focused on those studies in which the indication for AIT was mainly AD and only in patients with clinically confirmed allergy to house dust mites. Despite extensive evidence of the effectiveness of such treatment, studies on large patient populations are needed to determine the exact indications for AIT in AD patients with house dust mite allergy.

Food allergies can pose significant risks and profoundly impact the quality of life of children and their families, making them a major public health concern. Allergen avoidance has been the traditional mainstay of treatment; however, recent research has focused on various approaches to food allergen immunotherapy. This review summarizes the recent advancements in oral, sublingual, and epicutaneous immunotherapies, highlighting their respective advantages and disadvantages. The ultimate goal of food allergen immunotherapy is to maximize efficacy while minimizing risks, leading to the exploration of strategies such as low-dose immunotherapy and the use of biologics. When selecting candidates for immunotherapy among patients with food allergies, factors such as allergen characteristics, the likelihood of natural resolution, age, symptom severity, and impact on quality of life require consideration, and an individualized approach should be adopted to determine the most suitable treatment method.

Lars-Olaf Cardell,1,2,&ast; Thomas Sterner,3,&ast; Waqas Ahmed,4 Andreas Kallsoy Slættanes,5 Mikael Svärd,6 Richard F Pollock4 1Division of ENT Diseases, Department of Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden; 2Department of Otorhinolaryngology, Karolinska University Hospital, Stockholm, Sweden; 3Department of Economics, School of Business, Economics and Law, University of Gothenburg, Gothenburg, Sweden; 4Covalence Research Ltd, Harpenden, UK; 5ALK, Hørsholm, Denmark; 6ALK Nordic, Kungsbacka, Sweden&ast;These authors contributed equally to this workCorrespondence: Richard F Pollock, Email pollock@covalence-research.comAim: In Sweden, allergy immunotherapy (AIT) is available as either subcutaneous immunotherapy (SCIT) injections or sublingual immunotherapy (SLIT) tablets and is used to treat moderate-severe allergic rhinitis (AR). This study sought to determine direct and indirect annual costs stemming from treatment-related travel, appointments, waiting times and medication costs, before exploring likely CO2 emission-related cost-savings for 20,330 patients receiving SCIT or SLIT-tablets in Sweden.Methods: A model was developed in Python to capture each category of costs in the target patient population. Absenteeism costs arising from treatment-related travel were determined by obtaining average hourly pay data from Swedish Government sources. Absenteeism costs were also calculated for 30-minute post-dose observation times, which occurred during one clinical appointment for SLIT patients, and all clinical appointments for SCIT patients. Clinical appointment costs were obtained from healthcare price lists for Sweden. Medication costs were retrieved from the Pharmaceutical Specialities in Sweden (Fass) website, and treatment doses required for SCIT and SLIT-tablets were determined based on product labels and previously-calculated dosage regimes. High-cost protection and reimbursement scheme payment caps were applied when determining patient appointment and medication costs, respectively, and when identifying financial burdens for individual payers.Results: Mean total annual costs for SCIT were Swedish Krona (SEK) 604.1 million (m), with clinical appointments contributing the largest share of these costs (52.7%), followed by medication (34.4%), travel-related absenteeism (8.9%), waiting time-related absenteeism (2.7%) and private transportation (1.3%). Mean total annual costs for SLIT-tablets were SEK 336.2m. Medication contributed the most to these costs (72.3%), followed by clinical appointments (22.7%), travel-related absenteeism (3.8%), waiting time-related absenteeism (0.6%) and private transportation (0.6%).Conclusion: For patients with moderate-severe AR receiving AIT in Sweden, SLIT-tablets displayed large potential cost savings to patients, the healthcare system, and the government, whilst possessing reduced societal costs of carbon emissions relative to SCIT.Keywords: allergic rhinitis, costs, subcutaneous immunotherapy, sublingual immunotherapy

INTRODUCTION: Pollen is one of the most common triggers of an allergy or hay fever. It is a fine yellowish powder that fertilizes other plants and is carried by the wind, birds, insects, or other animals. Between 10% and 40% of the Indian population has a pollen allergy which makes it one of the most common outdoor allergies in the country. In Bengaluru, 20% of allergies are caused by pollens – Parthenium, Amaranthus spinosus, Prosopis juliflora, and Ricinus communis. AIMS: The aim was to study the therapeutic management of patients who are allergic to pollen at Bengaluru Allergy Centre and assessment of the quality of life (QOL) of patients. SETTINGS AND DESIGN: It was a prospective, interventional study conducted at Bengaluru Allergy Centre. SUBJECTS AND METHODS: Both male and female patients who have had chronic allergic rhinitis (CH AR) and also CH AR with other comorbidities and who have been taking treatment for more than 6 months are involved. The data were collected from case records of patients in the data collection form. Questionnaires were used to assess the QOL, and counseling was done to the pollen allergy patients. STATISTICAL ANALYSIS: A paired t-test was done using SPSS software for analyzing the P value, simple descriptive graphs, and pie charts, and the percentage was calculated. RESULTS: A total of 60 patients were enrolled in the study where 26 were male and 34 were female. The maximum number of patients was affected with weed pollen. Cynodon dactylon (13.97%) is the major sensitivity seen in patients. Sneezing, running nose, and itchy eyes are commonly seen in patients with AR due to pollens. The classification of AR with other comorbidities is CH AR (78.33%), CH AR + ANB (10%), CH AR + urticaria (6.66%), and CH AR + AD (5%). Patients’ symptoms were persistent at day (5%), night (8.33%), and both day and night (86.66%), whereas symptom severity in Bengaluru amounted to 41.66%, other than Bengaluru 16.66%, and both in and out of Bengaluru 41.66%. In Bengaluru Allergy Centre (BAC), the main treatment given is sublingual immunotherapy, nasal spray, vitamin supplements, pre- and probiotics, and influenza vaccine. Nasal and eye symptoms are commonly seen in patients with AR due to pollen, and QOL factors that significantly impacted were productivity at home/work, mental concentration, reading books or newspapers, outdoor life (e.g., sports and picnics), going out, visiting friends or relatives, sleeping, and tiredness. A decrease in the symptoms and an increase in the QOL were achieved by proper patient counseling and treatment. There is a significant reduction in symptom scores after the intervention. The intervention has a significant effect in reducing the symptom scores (t = 17.99, P < 0.001). CONCLUSIONS: It can be concluded that intervention by clinical pharmacists by way of patient counseling can help improve the reduction of symptoms and QOL of patients.

Allergic rhinitis (AR) is a prevalent disease in Canada that affects both children and adults. Several guidelines for the management of AR have been published by professional allergy societies worldwide. However, there are regional differences in the clinical management of AR, and regulatory approval of some AR pharmacotherapies varies among countries. Thus, six research questions specific to the treatment of AR in Canada were identified for this focused practice parameter. Reviews of the literature published since 2016 were conducted to obtain evidence-based support for the responses of the Work Group to each research question. In response to research question 1 "In patients with symptoms indicative of AR, is serum-specific IgE sufficient to identify candidates for immunotherapy or is a skin prick test mandatory?" the Work Group concluded that either sIgE testing or skin prick test are acceptable for diagnosing AR and guiding immunotherapy. In response to research question 2 "When taking into account the preferences of the patient and the prescriber (stakeholder engagement) should second-generation oral antihistamine (OAH) or intranasal corticosteroid (INCS) be first line?" the Work Group concluded that existing guidelines generally agree on the use of INCS as a first-line therapy used for AR, however, patient and provider preferences and considerations can easily shift the first choice to a second-generation OAH. In response to research question 3 "Is a combination intranasal antihistamine (INAH)/INCS formulation superior to INCS plus OAH? Do they become equivalent after prolonged use?" the Work Group concluded that that the combination INAH/INCS is superior to an INCS plus OAH. However, there was insufficient evidence to answer the second question. In response to research question 4 "Do leukotriene receptor antagonists (LTRA) have a greater benefit than OAH in AR for some symptoms to justify a therapeutic trial in those who cannot tolerate INCS?" the Work Group concluded that LTRAs have inferior, or at best equivalent, daytime or overall symptom control compared with OAH, but LTRAs may improve nighttime symptom control and provide benefits in patients with AR and concomitant asthma. In response to research question 5 "Should sublingual immunotherapy (SLIT) tablets be considered first-line immunotherapeutic options over subcutaneous immunotherapy (SCIT) based on the evidence of efficacy?" the Work Group concluded that the choice of SLIT or SCIT cannot be made on efficacy alone, and differences in other factors outweigh any differences in efficacy. In response to research question 6 "Based on efficacy data, should ALL patients seen by an allergist be offered SLIT or SCIT as a treatment option?" the Work Group concluded that the efficacy data suggests that SLIT or SCIT should be used broadly in patients with AR, but other clinical concerns also need to be taken into consideration. [ABSTRACT FROM AUTHOR]

Background: Polymerized allergoids conjugated with mannan represent a novel approach of allergen immunotherapy targeting dendritic cells. In this study, we aimed to determine the optimal dose of mannan-allergoid conjugates derived from grass pollen (Phleum pratense and Dactylis glomerata) administered via either the subcutaneous or sublingual route. Methods: A randomized, double-blind, placebo-controlled trial with a doubledummy design was conducted, involving 162 participants across 12 centers in Spain. Subjects were randomly allocated to one of nine different treatment groups, each receiving either placebo or active treatment at doses of 500, 1,000, 3,000, or 5,000 mTU/mL over four months. Each participant received five subcutaneous (SC) doses of 0.5 mL each, every 30 days, and a daily sublingual (SL) dose of 0.2 mL. Participants who received active treatment through SC, received placebo through SL. Participants who received active treatment through SL, received placebo SC. One Group, as control, received bot SC and SL placebo. The primary efficacy outcome was the improvement in titrated nasal provocation tests (NPT) at the end of the study compared to baseline. Secondary outcomes included specific antibody (IgG4, IgE) and cellular (IL-10 producing and regulatory T cell) responses. All adverse events and side reactions were recorded and assessed. Results: Post-treatment, the active groups showed improvements in NPT ranging from 33% to 53%, with the highest doses showing the greatest improvements regardless of the administration route. In comparison, the placebo group showed a 12% improvement. Significant differences over placebo were observed at doses of 3,000 mTU/mL (p=0.049 for SL, p=0.015 for SC) and 5,000 mTU/mL (p=0.011 for SL, p=0.015 for SC). A dose-dependent increase in IgG4 was observed following SC administration, and an increase in IL-10 producing cells for both routes of administration. No serious systemic or local adverse reactions were recorded, and no adrenaline was required. Conclusion: Grass pollen immunotherapy with mannan-allergoid conjugates was found to be safe and efficacious in achieving the primary outcome, whether administered via the subcutaneous or sublingual routes, at doses of 3,000 and 5,000 mTU/mL. [ABSTRACT FROM AUTHOR]

Background: Allergen immunotherapy is the only treatment that can achieve remission for allergic diseases. Aims/Objectives: To investigate the three-year adherence to sublingual immunotherapy for Japanese cedar pollinosis and house dust mite allergy at a clinic in Japan and identify factors that influence adherence and severe adverse reactions. Material and Methods: In total, 174 patients aged 12 years or older who started sublingual immunotherapy for Japanese cedar pollinosis (n = 72), house dust mite allergy (n = 55), or both (n = 47) between May 2017 and June 2018. Patient age, sex, type of pharmacotherapy used, adverse reactions, blood test results, and duration of continuous treatment were investigated. Results: The three-year treatment continuation rate was 40.8%. Adverse reaction rates were 12.6% for cedar pollinosis and 40.2% for house dust mite allergy. Patients with dose reductions due to severe reactions had lower first-year continuation rates. In the MITICURE® group, patients with severe reactions had significantly higher serum total IgE levels. Severe reactions were more common in MITICURE® patients with seven or more positive antigen types. Conclusions and Significance: Severe adverse reactions reduced early adherence. [ABSTRACT FROM AUTHOR]

Background: Sublingual immunotherapy (SLIT) for perennial allergic rhinitis (AR) has not been extensively studied in preschoolers. We investigated the efficacy and safety of house dust mite (HDM) SLIT‐tablet for children aged 1–4 years. Methods: Children aged 1–4 years with AR were divided into SLIT (n = 22) and control (n = 12) groups based on their guardians' preferences. The SLIT group received a daily dose of 10,000 JAU of HDM SLIT‐tablet for 12 months, whereas the control group received symptomatic treatment only. Results: The baseline median age was 41 and 34 months in the SLIT and control groups, respectively, and the median AR symptom score was 4 for both groups. Compared with baseline, the AR symptom score had decreased significantly in the SLIT group after 12 months (score: 3, p =.002), whereas it tended to increase in the control group (score: 6, p =.08). Adverse reactions to SLIT were mild and occurred in eight patients (36%). In the SLIT group, Dermatophagoides (D.) farinae‐specific IgE (sIgE) levels increased during the first 6 months and decreased to baseline levels at 12 months. In the control group, D. farinae‐sIgE levels had increased significantly at 12 months compared to baseline (p =.01). D. farinae‐specific IgG4 and HDM IgE‐blocking factor levels were significantly increased at 12 months compared to baseline in the SLIT group only (p <.001). A lower wheezing frequency was seen in the SLIT group (0.3%) compared to the control group (0.7%). Conclusion: This pilot study demonstrated the efficacy, safety, and immunomodulatory effects of HDM SLIT‐tablet in preschoolers with AR. [ABSTRACT FROM AUTHOR]

Background: House dust mite (HDM) sensitisation can contribute to the development of allergic rhinoconjunctivitis (AR) or allergic asthma (AA). As treatment, allergen immunotherapy (AIT) is a promising approach, since it aims building immunotolerance against allergens, therewith establishing long‐term efficacy. The evaluation of AIT has been investigated in many randomised controlled trials, whereas few real‐world evidence studies are available. Methods: We used data from the longitudinal prescription data base IQVIA™ LRx. Data on initial AIT prescriptions against HDM from January 2009 to December 2013 was analysed regarding treatment (subcutaneous AIT with either depigmented polymerised allergen extract [dSCIT] or other allergens [oSCIT], or sublingual immunotherapy [SLIT]) and treatment duration. Treatment groups were compared with a control group of AR patients not receiving AIT. Data on symptomatic medication was collected until February 2017 and progression of AR and AA was compared. Results: Data of 7260 patients with AIT prescriptions and of 21,780 control patients was analysed. AIT was associated with a significant decrease of AR medication intake compared with control (dSCIT: −34.0%, p < 0.0001; oSCIT: −25.7%, p < 0.0001; SLIT: −37.7%, p = 0.0026). In asthmatics, SCIT was associated with a significant decrease of asthma medication compared with control (dSCIT: −45.2%, p < 0.0001; oSCIT: −32.9%, p < 0.0001). Further, a significantly reduced likelihood for onset of asthma medication was demonstrated in patients treated with SCIT compared with controls (dSCIT OR: 0.759, p = 0.0476; oSCIT OR: 0.815, p = 0.0339). Conclusion: Real‐world data analyses indicate that AIT, particularly given via a subcutaneous route, reduces the need of medication against AR and AA and might delay the onset of asthma medication in patients with AR. [ABSTRACT FROM AUTHOR]

Background: The SQ tree sublingual immunotherapy (SLIT)‐tablet is authorised for treatment of allergic rhinoconjunctivitis with or without asthma in trees of the birch homologous group in 21 European countries. The primary objective of this study was to explore the safety in real‐life. Methods: In a prospective, non‐interventional post‐authorisation safety study (EUPAS31470), adverse events (AEs) and adverse drug reactions (ADRs) at first administration and follow‐up visits, symptoms, medication use, and pollen food syndrome were recorded by physicians in 6 European countries during the first 4–6 months of treatment. Results: ADRs with the SQ tree SLIT‐tablet were reported in 57.7% of 1069 total patients (median age 36.0 years, 53.7% female) during the entire observation period (severity, mild‐to‐moderate: 70.1%, severe: 4.7%, serious: 0.7%) and in 45.9% after first administration. ADRs were not increased with pollen exposure at first administration. With coadministration of the SQ tree and grass SLIT‐tablet AEs were reported in 73.8% of patients and in 52.8% with the SQ tree SLIT‐tablet alone. Nasal and eye symptoms improved in 86.9% and 80.9% of patients and use of symptomatic medication in 76.0%. PFS with symptoms was reported in 43.0% of patients at baseline and in 4.3% at the individual last visit. Conclusions: The results of this non‐interventional safety study with the SQ tree SLIT‐tablet confirm the safety profile from placebo‐controlled clinical trials and support effectiveness in real‐life according to the published efficacy data. Safety was not impaired by pollen exposure at first administration or co‐administration with other SLIT‐tablets. [ABSTRACT FROM AUTHOR]

Background: The clinical development program of the SQ grass, ragweed, tree, and house dust mite (HDM) sublingual immunotherapy (SLIT)-tablets for allergic rhinitis/conjunctivitis (AR/C) included clinical trials conducted in North America, Europe, and Japan. Objective: Data from these trials were analyzed to assess efficacy, immunologic mechanisms, and safety outcomes across allergens and geographic regions. Methods: Thirteen phase III, double-blind, placebo controlled trials in the subjects with AR/C were conducted in North America, Europe (including Russia), and Japan (N = 7763 analyzed). Trials were generally similar with respect to medical practice, target population, eligibility criteria, and efficacy and safety monitoring. Data were analyzed for the approved doses in North America and Europe. Four statistical models were used to enhance comparison of the efficacy end points among the trials. Results: The SLIT-tablets demonstrated consistent efficacy across allergens and regions, regardless of the statistical analysis used. Relative improvement in the primary efficacy end point compared with placebo by using the predefined protocol analysis ranged from 17.9% to 32.8%, 17.5% to 19.3%, 20.6% to 38.3%, and 39.6% with the grass, HDM, ragweed, and tree SLITtablets, respectively. The kinetics of specific immunoglobulin E (IgE) and IgG4 responses were similar among the allergens and regions. Local application-site reactions were the most common adverse events for all allergens and in all regions. Most treatment-related adverse events for all allergens and in all regions were mild in severity. The rate of systemic allergic reactions was similar across regions (0%–0.54%). Conclusion: Confirmatory phase III trials for SLIT-tablets in the treatment of AR/C showed consistent efficacy, immunologic, and safety outcomes across allergens and geographic regions. [ABSTRACT FROM AUTHOR]

Allergen vulnerability is highly individual specific. House dust mites (HDMs) are major sources of airborne allergens, found not only in houses but also detected in workplaces and most schools. The two most common HDM species from the Pyroglyphidae family, namely Dermatophagoides pteronyssinus and Dermatophagoides farinae are responsible for 90% of sensitization and allergic symptoms. Clinical conditions due to HDM allergen are rhinitis, conjunctivitis, asthma and/or atopic dermatitis (AD), and rare severe systemic reaction. Accurate diagnosis by skin prick test, specific immunoglobulin E (extract and component-based), or nasal provocation test with standardized HDM extract in contest with clinically relevant exposure to dust mites is fundamental for successful treatment. Allergen immunotherapy (AIT) is the only treatment providing sustained efficacy for moderate-to-severe allergic rhinitis, allergic asthma, and AD. This review will mainly focus on the description of HDM allergens, immunology, efficacy, and HDM-AIT (subcutaneous immunotherapy and sublingual immunotherapy). [ABSTRACT FROM AUTHOR]

The aim of this review is to investigate the possible role of allergen immunotherapy (AIT) for house dust mites in the treatment of atopic dermatitis in adult patients (AD). AIT is a commonly accepted treatment for selected allergic diseases such as allergic rhinitis, bronchial asthma, allergy to venom, and sometimes food allergy. There have been a few original reports on improving AD symptoms due to subcutaneous and sublingual immunotherapy with selected allergens, mainly house dust mites. However, the precise role of immunotherapy in treating atopic dermatitis (AD) is still not clearly defined despite some studies that have been conducted. The review discusses available studies that provide evidence of the efficacy of AIT in patients with AD who are allergic to house dust mites. The authors focused on those studies in which the indication for AIT was mainly AD and only in patients with clinically confirmed allergy to house dust mites. Despite extensive evidence of the effectiveness of such treatment, studies on large patient populations are needed to determine the exact indications for AIT in AD patients with house dust mite allergy. [ABSTRACT FROM AUTHOR]