Randomized controlled trial of primary prevention of atopy using house dust mite allergen oral immunotherapy in early childhood
Randomized controlled trial of primary prevention of atopy using house dust mite allergen oral immunotherapy in early childhood
Methods
This was a prospective, randomized, double-blind, placebo-controlled, proof-of-concept study involving 111 infants less than 1 year of age at high risk of atopy (?2 first-degree relatives with allergic disease) but with negative skin prick test responses to common allergens at randomization. HDM extract (active) and appropriate placebo solution were administered orally twice daily for 12 months, and children were assessed every 3 months. Coprimary outcomes were cumulative sensitization to HDM and sensitization to any common allergen during treatment, whereas development of eczema, wheeze, and food allergy were secondary outcomes. All adverse events were recorded.
Results
There was a significant (P = .03) reduction in sensitization to any common allergen (16.0%; 95% CI, 1.7% to 30.4%) in the active (5 [9.4%]) compared with placebo (13 [25.5%]) treatment groups. There was no treatment effect on the coprimary outcome of HDM sensitization and the secondary outcomes of eczema, wheeze, and food allergy. The intervention was well tolerated, with no differences between active and placebo treatments in numbers or nature of adverse events.
Conclusion
Prophylactic HDM oral immunotherapy is well tolerated in children at high heredity risk. The results met the trial's prespecified criteria for proof of concept in reducing sensitization to any allergen; however, no significant preventive effect was observed on HDM sensitization or allergy-related symptoms.
atopy, house dust mite, imp, investigational medical product, spt, skin prick test, treg, regulatory T
1541-1547.e11
Zolkipli, Zaraquiza
cf921a9a-b6be-4f68-aa6a-842eff290a8a
Roberts, Graham
ea00db4e-84e7-4b39-8273-9b71dbd7e2f3
Cornelius, Victoria
b75c21d7-2c25-495c-9107-e39453a72bdd
Clayton, Bernie
11035c05-1641-4c79-bf67-392c6f493de6
Pearson, Sarah
0965edba-1d1f-4080-85a0-41b53d3cb553
Michaelis, Louise
8e4308eb-eaba-4675-aa54-2c8c6057c88c
Djukanovic, Ratko
d9a45ee7-6a80-4d84-a0ed-10962660a98d
Kurukulaaratchy, Ramesh
9c7b8105-2892-49f2-8775-54d4961e3e74
Arshad, S. Hasan
917e246d-2e60-472f-8d30-94b01ef28958
December 2015
Zolkipli, Zaraquiza
cf921a9a-b6be-4f68-aa6a-842eff290a8a
Roberts, Graham
ea00db4e-84e7-4b39-8273-9b71dbd7e2f3
Cornelius, Victoria
b75c21d7-2c25-495c-9107-e39453a72bdd
Clayton, Bernie
11035c05-1641-4c79-bf67-392c6f493de6
Pearson, Sarah
0965edba-1d1f-4080-85a0-41b53d3cb553
Michaelis, Louise
8e4308eb-eaba-4675-aa54-2c8c6057c88c
Djukanovic, Ratko
d9a45ee7-6a80-4d84-a0ed-10962660a98d
Kurukulaaratchy, Ramesh
9c7b8105-2892-49f2-8775-54d4961e3e74
Arshad, S. Hasan
917e246d-2e60-472f-8d30-94b01ef28958
Zolkipli, Zaraquiza, Roberts, Graham, Cornelius, Victoria, Clayton, Bernie, Pearson, Sarah, Michaelis, Louise, Djukanovic, Ratko, Kurukulaaratchy, Ramesh and Arshad, S. Hasan
(2015)
Randomized controlled trial of primary prevention of atopy using house dust mite allergen oral immunotherapy in early childhood.
Journal of Allergy and Clinical Immunology, 136 (6), .
(doi:10.1016/j.jaci.2015.04.045).
(PMID:26073754)
Abstract
Methods
This was a prospective, randomized, double-blind, placebo-controlled, proof-of-concept study involving 111 infants less than 1 year of age at high risk of atopy (?2 first-degree relatives with allergic disease) but with negative skin prick test responses to common allergens at randomization. HDM extract (active) and appropriate placebo solution were administered orally twice daily for 12 months, and children were assessed every 3 months. Coprimary outcomes were cumulative sensitization to HDM and sensitization to any common allergen during treatment, whereas development of eczema, wheeze, and food allergy were secondary outcomes. All adverse events were recorded.
Results
There was a significant (P = .03) reduction in sensitization to any common allergen (16.0%; 95% CI, 1.7% to 30.4%) in the active (5 [9.4%]) compared with placebo (13 [25.5%]) treatment groups. There was no treatment effect on the coprimary outcome of HDM sensitization and the secondary outcomes of eczema, wheeze, and food allergy. The intervention was well tolerated, with no differences between active and placebo treatments in numbers or nature of adverse events.
Conclusion
Prophylactic HDM oral immunotherapy is well tolerated in children at high heredity risk. The results met the trial's prespecified criteria for proof of concept in reducing sensitization to any allergen; however, no significant preventive effect was observed on HDM sensitization or allergy-related symptoms.
Text
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Accepted/In Press date: 27 April 2015
e-pub ahead of print date: 12 June 2015
Published date: December 2015
Keywords:
atopy, house dust mite, imp, investigational medical product, spt, skin prick test, treg, regulatory T
Organisations:
Human Development & Health
Identifiers
Local EPrints ID: 388678
URI: http://eprints.soton.ac.uk/id/eprint/388678
ISSN: 0091-6749
PURE UUID: e39c41c0-c08a-478b-8a0c-94ac0ead91a0
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Date deposited: 01 Mar 2016 16:23
Last modified: 15 Mar 2024 03:22
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Contributors
Author:
Zaraquiza Zolkipli
Author:
Victoria Cornelius
Author:
Bernie Clayton
Author:
Sarah Pearson
Author:
Louise Michaelis
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