BASALIT trial: double-blind placebo-controlled allergen immunotherapy with rBet v 1-FV in birch-related soya allergy.
Allergy
; 72(8): 1243-1253, 2017 Aug.
Article
en En
| MEDLINE
| ID: mdl-27998002
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-blind placebo-controlled food challenge (DBPCFC) with soya. A total of 56 of 82 were randomized in the ratio of 21 (active placebo). Per-protocol population (PPP) had received ≥150 µg of allergen or placebo preparation. OUTCOMEMEASURES:
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.Palabras clave
Texto completo:
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Banco de datos:
MEDLINE
Asunto principal:
Glycine max
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Rinitis Alérgica Estacional
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Desensibilización Inmunológica
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Betula
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Antígenos de Plantas
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Hipersensibilidad a los Alimentos
Tipo de estudio:
Clinical_trials
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Diagnostic_studies
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Guideline
Límite:
Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Año:
2017
Tipo del documento:
Article