R Treudler1, A Franke2, A Schmiedeknecht2, B Ballmer-Weber3, M Worm4, T Werfel5, U Jappe6,7, T Biedermann8,9, J Schmitt10,11, R Brehler12, A Kleinheinz13, J Kleine-Tebbe14, H Brüning15, F Ruëff16, J Ring9, J Saloga17, K Schäkel18, T Holzhauser19, S Vieths19, J C Simon1. 1. Department of Dermatology, Venerology and Allergology, Universität Leipzig, Leipzig, Germany. 2. Clinical Trial Centre Leipzig (ZKS), Universität Leipzig, Leipzig, Germany. 3. Allergy Unit, Department of Dermatology, University Hospital Zürich and Centre of Dermatology and Allergology, Luzerner Kantonsspital, Luzern, Germany. 4. Allergy Center Charité, Department of Dermatology, Venerology and Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany. 5. Department of Dermatology and Allergology, MH Hannover, Hannover, Germany. 6. Division of Clinical & Molecular Allergology Research Center Borstel, Airway Research Center North (ARCN) and Member of the German Center for Lung Research (DZL), Borstel, Germany. 7. Interdisciplinary Allergy Outpatient Clinic, Department of Internal Medicine, University of Lübeck, Lübeck, Germany. 8. Department of Dermatology, Universität Tübingen, Tübingen, Germany. 9. Department of Dermatology and Allergology, Technical University Munich, Munich, Germany. 10. Department of Dermatology, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany. 11. Center for Evidence-based Healthcare, Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany. 12. Department of Dermatology, Universität Münster, Münster, Germany. 13. Department of Dermatology, Elbekliniken Buxtehude, Buxtehude, Germany. 14. Allergy- and Asthma Centre Westend, Berlin, Germany. 15. Day care clinic for Allergy and Dermatology, Kiel, Germany. 16. Department of Dermatology and Allergology, Ludwig-Maximilian University, Munich, Germany. 17. Department of Dermatology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany. 18. Department of Dermatology, Ruprecht-Karls-Universität Heidelberg, Heidelberg, Germany. 19. Division of Allergology, Paul-Ehrlich-Institut, Langen, Germany.
Abstract
BACKGROUND: Conflicting results exist on the effect of allergen immunotherapy (AIT) on pollen-related food allergy. We aimed to investigate the efficacy of one-year AIT with the folding variant (FV) of recombinant (r) Bet v 1 on birch-related soya allergy. METHODS: Of 138 subjects with Bet v 1 sensitization, 82 were positive at double-blindplacebo-controlled food challenge (DBPCFC) with soya. A total of 56 of 82 were randomized in the ratio of 2:1 (active: placebo). Per-protocol population (PPP) had received ≥150 μg of allergen or placebo preparation. OUTCOME MEASURES: lowest observed adverse effect levels (LOAEL), postinterventional occurrence of objective signs (objS) at any dose level, sIgE/IgG4 against Bet v 1 and Gly m 4. Between-group changes were investigated (ancova, Mann-Whitney U-test, Fisher exact test). RESULTS: Baseline characteristics including LOAELs were comparable in both groups with objS and subjS occurring in 82% and 95% of active (n = 38) vs 78% and 83% of placebo group (n = 18). After AIT, objS occurred in 24% and 47%, respectively. LOAEL group differences showed a beneficial tendency (P = 0.081) for LOAELobjective in PPP (30 active, 15 placebo). sIgG4 raised only in active group (Bet v 1: P = 0.054, Gly m 4: P = 0.037), and no relevant changes occurred for sIgE. Only 56% of the intended sample size was recruited. CONCLUSION: For the first time, we present data on the effect of rBet v 1-FV on birch-related soya allergy. rBet v 1-FV AIT induced significant immunogenic effects. Clinical assessment showed a tendency in favour of the active group but did not reach statistical significance.
RCT Entities:
BACKGROUND: Conflicting results exist on the effect of allergen immunotherapy (AIT) on pollen-related food allergy. We aimed to investigate the efficacy of one-year AIT with the folding variant (FV) of recombinant (r) Bet v 1 on birch-related soya allergy. METHODS: Of 138 subjects with Bet v 1 sensitization, 82 were positive at double-blind placebo-controlled food challenge (DBPCFC) with soya. A total of 56 of 82 were randomized in the ratio of 2:1 (active: placebo). Per-protocol population (PPP) had received ≥150 μg of allergen or placebo preparation. OUTCOME MEASURES: lowest observed adverse effect levels (LOAEL), postinterventional occurrence of objective signs (objS) at any dose level, sIgE/IgG4 against Bet v 1 and Gly m 4. Between-group changes were investigated (ancova, Mann-Whitney U-test, Fisher exact test). RESULTS: Baseline characteristics including LOAELs were comparable in both groups with objS and subjS occurring in 82% and 95% of active (n = 38) vs 78% and 83% of placebo group (n = 18). After AIT, objS occurred in 24% and 47%, respectively. LOAEL group differences showed a beneficial tendency (P = 0.081) for LOAELobjective in PPP (30 active, 15 placebo). sIgG4 raised only in active group (Bet v 1: P = 0.054, Gly m 4: P = 0.037), and no relevant changes occurred for sIgE. Only 56% of the intended sample size was recruited. CONCLUSION: For the first time, we present data on the effect of rBet v 1-FV on birch-related soya allergy. rBet v 1-FV AIT induced significant immunogenic effects. Clinical assessment showed a tendency in favour of the active group but did not reach statistical significance.
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