S. Preis

and 13 more

Background: A complex interaction between environmental and lifestyle factors, immune dysregulation, and skin barrier integrity is believed to contribute to the development of atopic dermatitis (AD). However, the precise mechanisms underlying disease onset in infants remain largely unclear. Methods: The ‘Munich Atopic Prediction Study’ (MAPS) is a comprehensive clinical and laboratory investigation of a prospective birth cohort from Munich, Germany. Information on pregnancy, child development, environmental influences, parental exposure to potential allergens, as well as illnesses affecting both children and parents is gathered through questionnaires. This is complemented by thorough clinical examinations conducted by trained dermatologists, with a focus on allergies and skin health. Biomarker analyses were performed on cord blood immune cells using flow cytometry. Results: Our analysis revealed an altered immune profile in the cord blood of infants who later developed AD, characterized by reduced frequencies of CD4 + T cells and increased B cell counts. Remarkably, however, regulatory B (Breg) cell frequencies were significantly reduced in these infants. Furthermore, our findings suggested that maternal allergen-specific immunotherapy may have a beneficial effect on the development and frequency of Breg cells. Conclusion: Our study identifies early immune alterations, particularly a reduction in cord blood Breg cells, as potential contributors to AD pathogenesis. These findings demand further research on B cells in the development of atopic diseases as B cells may participate in the initiation or prevention of these diseases. Specifically, inclusion of Breg cell measurements in neonatal immune panels could support early risk stratification and perceptively even personalized prevention of atopic diseases.

Tilo Biedermann

and 3 more

Background: The SQ tree SLIT-tablet has recently been approved for treatment of tree pollen allergy. Health care workers should be provided with detailed safety data for clinical use. Objective: To assess the tolerability and safety of the SQ tree SLIT-tablet in adults and adolescents. Methods: Safety data were pooled from two phase-II and one phase-III double-blinded, randomized, placebo-controlled trials including adults and adolescents with allergic rhinitis and/or conjunctivitis treated before and during one pollen season once-daily with the SQ tree SLIT-tablet (12 SQ-Bet) or placebo. Results: The most frequently reported IMP-related AEs with 12 SQ-Bet were oral pruritis (39% of subjects) and throat irritation (29%). IMP-related AEs were mainly mild or moderate in severity, and the majority resolved without treatment and did not lead to treatment interruption/discontinuation. With 12 SQ-Bet, oral pruritus was more frequent among PFS subjects (45%) than in subjects without PFS (29%). A greater proportion of PFS subjects interrupted treatment (19%) than subjects without PFS (7%). The 12 SQ-Bet did not seem to induce an increased risk of asthma: 7 events were reported in 7 subjects with 12 SQ-Bet and 11 in 10 subjects with placebo. No differences were seen in the risk of moderate to severe IMP-related AEs regardless of age, PFS status and asthma medical history. Conclusions: The 12 SQ tree SLIT-tablet was well tolerated in tree pollen allergic subjects with no major safety concerns detected. This safety profile supports daily at-home sublingual administration once the first dose is tolerated when administered under medical supervision.