In:
Allergy, Wiley, Vol. 72, No. 8 ( 2017-08), p. 1243-1253
Abstract:
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 LOAEL s 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 LOAEL objective in PPP (30 active, 15 placebo). sIgG 4 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 rB et v 1‐ FV on birch‐related soya allergy. rB et 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.
Type of Medium:
Online Resource
ISSN:
0105-4538
,
1398-9995
DOI:
10.1111/all.2017.72.issue-8
Language:
English
Publisher:
Wiley
Publication Date:
2017
detail.hit.zdb_id:
2003114-2
Bookmarklink