Randomized controlled trial of primary prevention of atopy using house dust mite allergen oral immunotherapy in early childhood - 04/12/15
Abstract |
Background |
Children born to atopic parents are at increased risk of sensitization to environmental allergens.
Objective |
We sought to demonstrate proof of concept for oral immunotherapy to high-dose house dust mite (HDM) allergen in infancy in the prevention of allergen sensitization and allergic diseases.
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.
El texto completo de este artículo está disponible en PDF.Key words : Atopy, house dust mite, oral immunotherapy, primary prevention, randomized controlled trial, allergen, infant, early childhood
Abbreviations used : HDM, IMP, SPT, Treg
Esquema
| Supported by the National Institute for Health Research (NIHR), United Kingdom. This report is independent research by the NIHR RBRU Funding Scheme. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health. |
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| Disclosure of potential conflict of interest: Z. Zolkipli has received travel support from Thermo Fisher. G. Roberts has received research support from the National Institute for Health Research (NIHR), has received lecture fees and intervention and placebo medications from ALK-Abelló, is a member of the ALK-Abelló advisory board, and has a patent held by the university. R. Djukanovic has received institutional research support from the NIHR, has received consultancy fees from Teva Pharmaceuticals, has received research support from IMI and MRC, has received lecture fees from Novartis, has stock in Synairgen, and has received travel support from Boehringer Ingelheim. S. H. Arshad has received research support from the NIHR and ALK-Abelló, has received consultancy fees from Merck, and has a patent for the use of house dust mite allergen immunotherapy for primary prevention of asthma and atopy. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 136 - N° 6
P. 1541 - décembre 2015 Regresar al número
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