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To the Editor, Over the last decades, systematic reviews and meta analyses of multiple double-blind randomized placebo-controlled trials have demonstrated the efficacy and safety of both subcutaneous (SCIT) and sublingual (SLIT) allergen immunotherapy (AIT) for respiratory and insect venom allergy.[1] However, there is a wide range of AIT preparations used around the globe, and AEs are not always uniformly recorded, limiting the capability to draw safe conclusions or compare reports. Though various clinical development programs[2] have generated substantial knowledge on different AIT preparations, they have been conducted in pre-defined clinical conditions, not reflecting real-life and therefore the results may not have generalized applicability.[3] Very few pragmatic trials and observational studies have evaluated AIT safety in real-life. Adverse Events Registry is the first AIT Registry for AE piloted in different countries in Europe that uses the harmonized MedDRA terminology[9] (Table 1). [Extracted from the article]

Background: Although it has been shown that allergen immunotherapy (AIT) is well‐tolerated in children, systematic and prospective surveillance of AIT safety in real life settings is needed. Methods: The multinational Allergen Immunotherapy Adverse Events Registry (ADER) was designed to address AIT safety in real life clinical practice. Data on children ≤18 years old with respiratory allergies undergoing AIT were retrieved. Patient‐ and AIT‐related features were collected and analyzed. The characteristics of adverse events (AE) and risk factors were evaluated. Results: A total of 851 patients, 11.3 ± 3.4 years old, with rhinitis only (47.6%); asthma and rhinitis (44.5%); asthma (7.9%), receiving 998 AIT courses were analyzed. Sublingual immunotherapy (SLIT) accounted for 51% of the courses. In 84.5% of patients only one AIT treatment was prescribed. Pollen was the most frequent sensitizer (57.1%), followed by mites (53.4%), molds (18.2%) and epithelia (16.7%). Local and systemic AEs were reported in 85 patients (9.9%). Most AEs (83.1%) were mild and occurred in <30 min (87%). Respiratory and cutaneous symptoms were more frequent. Only 4 patients (0.47%) had severe AE (none after 6 weeks of maintenance). The risk of AE was higher in patients undergoing SCIT. Conclusions: AIT is safe and well tolerated in children and adolescents with respiratory allergies in real‐life clinical practice. Though SCIT is more prone to AE compared to SLIT, overall severe reactions are rare and occur during build‐up and early maintenance. [ABSTRACT FROM AUTHOR]

• Allergen immunotherapy mainly induces T regulatory cells and blocking IgG4 antibodies. • Tolerance induction and asthma prevention are key goals of immunotherapy. • New forms of allergens, adjuvants, and carriers result in increased immunogenicity. • Objective markers of efficacy (biomarkers) are urgently needed to follow immunotherapy. Allergen immunotherapy leads to tolerance through multiple mechanisms that include tolerogenic dendritic cells and T and B regulatory cells. These induced cellular populations produce mediators to skew the immune response to a tolerogenic milieu that, among others, results in IgG4 blocking antibodies formation and lowered FcE receptors. All lead in decreased effector responses from mast cells, eosinophils, and basophils thus limiting the allergic inflammation. Clinically, this results in better allergic rhinitis control and, of importance, asthma prevention. Newer approaches include modified allergens, second generation adjuvants/carriers and routes of administration, all aiming to increased efficacy with parallel no compromise of safety. [ABSTRACT FROM AUTHOR]

Background: Nasal irrigations (NI) are increasingly used as an over-the-counter adjunctive treatment for allergic rhinitis (AR), but clinical studies on their effectiveness are limited. Methods: An open-label, controlled, non-randomized, real-life study was conducted to evaluate the effectiveness of NI with a new hypertonic solution as add-on treatment for AR. Children and adolescents with AR were prescribed symptomatic treatment. The active group also received an additional sea-water NI solution supplemented with algae extracts. The primary endpoint was symptom control, assessed by the control of allergic rhinitis and asthma test (CARAT) questionnaires. Moreover, the MASK/Allergy Diary was used to track symptoms and daily medication use that were combined in a novel total symptom/medication score (TSMS). Results: We assessed 76 patients. Overall, there was a significant improvement of CARAT results (median Z-score change of 1.1 in the active/NI group vs. 0.4 in the control group; p = 0.035). Among patients > 12 years old (n = 51), there was a significant improvement in CARAT10 results among participants receiving NI (21.0 to 25.5; p < 0.001), but not in the regular treatment group (21.5 to 24.0; p = 0.100). For children < 12 years old (n = 25), the ΝΙ group had significantly improved symptom control (CARATKids results: 5.0 to 2.0; p = 0.002), in contrast to the control group (4.0 to 2.5; p = 0.057). MASK data on allergic symptoms were comparable between groups. However, the NI group had lower TSMS, more days with < 20% symptoms and fewer days using symptomatic treatment (26.9% vs. 43.5%; p = 0.005). Conclusion: Addition of NI with a sea-water solution to regular treatment improved AR symptom control. CARAT questionnaires and MASK application can be useful outcome tools in real-life studies. [ABSTRACT FROM AUTHOR]

Correct identification of the culprit allergen is an essential part of diagnosis and treatment in immunoglobulin E (IgE)-mediated allergic diseases. In recent years, molecular biology has made important advances facilitating such identification and overcoming some of the drawbacks of natural allergen extracts, which consist of mixtures of various proteins that may be allergenic or not, specific for the allergen source or widely distributed (panallergens). New technologies offer the opportunity for a more accurate component-resolved diagnosis, of benefit especially to polysensitized allergic patients. The basic elements of molecular diagnostics with potential relevance to immunotherapy prescription are reviewed here, with a focus on Southern European sensitization patterns to pollen allergens. We propose a basic algorithm regarding component-resolved diagnostic work-up for pollen allergen-specific immunotherapy candidates in Southern Europe; this and similar algorithms can form the basis of improved patient management, conceptually a 'Component-Resolved Allergy Management'. Copyright © 2013 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]