BASALIT trial: double-blind placebo-controlled allergen immunotherapy with rBet v 1-FV in birch-related soya allergy
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 sensi...
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| Hauptverfasser: | , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2017
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| In: |
Allergy
Year: 2016, Jahrgang: 72, Heft: 8, Pages: 1243-1253 |
| ISSN: | 1398-9995 |
| DOI: | 10.1111/all.13112 |
| Online-Zugang: | Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1111/all.13112 Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/all.13112 
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| Verfasserangaben: | R. Treudler, A. Franke, A. Schmiedeknecht, B. Ballmer‐Weber, M. Worm, T. Werfel, U. Jappe, T. Biedermann, J. Schmitt, R. Brehler, A. Kleinheinz, J. Kleine‐Tebbe, H. Brüning, F. Ruëff, J. Ring, J. Saloga, K. Schäkel, T. Holzhauser, S. Vieths & J.C. Simon |
| Zusammenfassung: | 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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| Beschreibung: | Article was first published on 20 December 2016 Gesehen am 06.08.2018 |
| Beschreibung: | Online Resource |
| ISSN: | 1398-9995 |
| DOI: | 10.1111/all.13112 |