Background: Subcutaneous immunotherapy has emerged as an effective option for treating allergic diseases. Here, we assessed the clinical impact of the mannan‐conjugated birch pollen polymerized allergoid T502 in birch pollen‐induced allergic rhinoconjunctivitis. Methods: In this prospective, randomized, double‐blind placebo‐controlled phase III trial, 298 birch pollen–allergic adult patients were treated across 28 trial sites in Germany. Patients received either placebo or 23,000 mTU T502 subcutaneously over five pre‐seasonal visits. Efficacy was assessed by comparing the combined symptom and medication score (CSMS) between placebo and T502 during the peak birch pollen season 2022. Safety, tolerability and immunologic effects were also analyzed. Results: During the peak birch pollen season, the median CSMS of the T502 group was reduced by 33% ( p = 0.002) compared to placebo. The median daily symptom score and daily medication score were reduced by 30.4% ( p < 0.001) and 56.3% ( p = 0.045), respectively. Health related quality of life improved as reflected by reduction of RQLQ values by 31.5% ( p < 0.0001). Production of Bet v 1 sIgG4 and Bet v 1 sIgG increased up to 6.2‐fold and 3‐fold respectively in the T502 group ( p < 0.0001). The sIgE/sIgG4 ratio was strongly reduced in the T502 group at V7 (−62.9%, p < 0.0001). No fatalities nor serious adverse events were reported. In total, 16 systemic allergic reactions occurred (Grade I/II). Conclusions: Treatment with T502 significantly reduced symptoms and medication need in rhinoconjunctivitis patients. The treatment is well tolerated and safe.

Background: Storage mites are frequently found in our daily environment. Nevertheless, storage mite allergy is often neglected in allergological diagnostics and possible allergies requiring therapy are thus overlooked. Methods: Recommendations for action are made based on a literature review from March 2021 to August 2021 in PubMed, Medline, and GoogleScholar. Results: This review article provides an overview of the species of storage mites, sensitization rates in different countries and occupations, and co-sensitization rates to house dust mite. Recommendations for diagnosis as well as therapy are given. The importance of provocation testing as well as causal therapy by allergen immunotherapy (AIT) is presented. Conclusion: The position paper gives recommendations for the diagnosis and therapy of allergic rhinitis in case of storage mite allergy. AIT is recommended in symptomatic allergy and proven storage mite allergy. Reliable detection by provocation testing is advised in this persistent allergy. The therapy should be carried out independently of the treatment of a possible house dust mite allergy.

House dust mites are a major source of allergens in house dust and, thus, the main trigger of perennial allergic respiratory diseases [1–5]. Scientific research on the life cycle, diet, and reproductive behavior of dust mites and on the biology of mite allergens has uncovered mechanisms leading to the development of respiratory allergies and suggests measures that can minimize exposure to dust mite allergens. Here, we discuss the evidence linking house dust mite exposure and respiratory allergies and present the efficacy of avoidance measures and their scientific evidence.

Background: Mannan‐conjugated allergoids represent an effective option for treating allergic diseases. This study evaluated the clinical impact of the mannan‐conjugated, polymerised birch pollen allergoid EP‐088_T502 in patients with birch pollen‐induced allergic rhinoconjunctivitis over 3 years. Methods: Following up to a double‐blind, placebo‐controlled dose‐finding study, in this open, long‐term extension study, 154 birch pollen‐allergic patients were enrolled in Germany. Patients were treated with a cumulative dose of 48,000 mTU EP‐088_T502 administered subcutaneously over five pre‐seasonal visits in each of the two treatment years (2021, 2022) with a subsequent follow‐up year in 2023. The primary efficacy endpoint was the combined symptom and medication score (CSMS) during the peak birch pollen season, which was compared with the CSMS of the placebo group during the peak pollen season of 2020. Safety, tolerability, and immunogenicity were also analysed. Results: Compared to the placebo group of the preceding study, median CSMS during the peak birch pollen seasons showed reductions of 47.5% in 2021 ( p < 0.001), 51.8% in 2022 ( p < 0.001), and 36.5% in 2023 ( p < 0.001). Median daily symptom scores were reduced by 40.7% in 2021 ( p < 0.001), 40.7% in 2022 ( p < 0.001), and 25.6% in 2023 ( p < 0.010). Median daily medication scores reached 0.07 in 2021 and 0.04 in 2022 ( p < 0.001) and were reduced by 65.9% in 2023 ( p < 0.003). Immunological responses showed a 4.82‐fold increase in Bet v1 sIgG4 ( p = 0.001) and a marked decrease (−65.5%, p = 0.001) in the sIgE/sIgG4 ratio after the first treatment phase. EP‐088_T502 demonstrated good safety and tolerability, with only six mild to moderate systemic allergic reactions (Grade I/II). No epinephrine was used. Conclusion: In this open‐label study, two consecutive years of pre‐seasonal short‐course allergen immunotherapy (AIT) with EP‐088_T502 markedly reduced symptoms and medication need in patients with birch pollen‐induced rhinoconjunctivitis. Persistent therapeutic effects observed during the follow‐up year, although limited by attrition of the study population, suggest sustained clinical improvement and indicate the potential disease‐modifying impact of this treatment regimen.

Die chronische Rhinosinusitis (CRS) zählt mit einer Prävalenz von bis zu 12 % zu einer der häufigsten chronischen Erkrankungen. Die Betroffenen berichten über eine starke Einschränkung ihrer Lebensqualität und meist einen langen Leidensweg. Trotz der bisherigen Standardtherapie ist die Erkrankung oft nicht ausreichend kontrolliert. Der folgende Artikel beschreibt Indikationen und Durchführung einer neuen Therapieoption mit Biologika. Chronic rhinosinusitis (CRS) is defined as an inflammation of the nose and paranasal sinuses with prevalence of 10.9 % and by the presents of 2 or more symptoms, which last more than 12 weeks. The symptoms are nasal obstruction, nasal discharge (anterior/post nasal drip), facial pain or pressure and/or olfactory disorder. CRS has a high negative impact on an individual’s quality of life. The pathogenesis is multifactorial and complex. CRS has been subclassified into 2 groups: CRS with nasal polyps (CRSwNP) and CRS without nasal polyps (CRSsNP). Regarding further knowledge of the inflammatory pathway the primary CRS is considered by endotype dominance, either type 2 or non-type 2. 80 % of the CRSwNP reveals a type 2 inflammation. The proteins, interleukin (IL)-4, IL-5, IL-13, and IgE were previously identified as key mediators in nasal polyp tissues pattern. CRSwNP is often refractory to medical and surgical management, especially in patients with asthma and aspirin intolerance. In most cases the control of the disease is a challenge. Patients with asthma but especially with Samter’s triad are significantly more likely to have a recurrence of nasal polyps and undergo a second surgery following recurrence. In patients with severe CRSwNP, in whom the current standard of care including topical and oral corticosteroids, antibiotics and surgical procedures fail to control the disease, biologics can open new perspectives in treatment. They allow avoiding the possible adverse events resulting from repeated use of systemic corticosteroids and surgery. These biologics have a high impact on type 2 immune reaction and lead to a reduction of IgE as well as of local mucosal eosinophil migration and activation, resulting in a significant effect on nasal polyps, smell, quality of life and asthma comorbidity. Publication Date: 01 February 2021 (online) © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany