Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build‐up phase of a randomized, double‐blind, placebo‐controlled trial (PITA study)

Peanut gastrointestinal delivery oral immunotherapy in adolescents: Results of the build‐up phase of a randomized, double‐blind, placebo‐controlled trial (PITA study)

Summary Background Oral immunotherapy to peanut is effective in desensitizing patients but has significant side effects including anaphylaxis and gastrointestinal symptoms. In most protocols, peanut is administered in a vehicle food. Objective In an exclusively adolescent population, we tested a new...

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Published in:Clinical and experimental allergy Vol. 48; no. 7; pp. 862 - 874
Main Authors: Fauquert, J.‐L., Michaud, E., Pereira, B., Bernard, L., Gourdon‐Dubois, N., Rouzaire, P.‐O., Rochette, E., Merlin, E., Evrard, B., Allali, Sanae, Alrawi, Amna, Bardon, Claire, Barre, Annick, Brunet, Anne‐Sophie, Buisson, François, Chapuis, Alexandra, Chausset, Aurélie, Cormouls, Nicolas, Dampfhoffer, Marie, Deguillaume, Sophie, Demoly, Pascal, Dubray, Claude, Latour, Anne Dupré, Egron, Carole, Fel, Solenne, Gallego, Cecile Hiss, Héraud, Marie‐Christine, Labbé, André, Labbé, Guillaume, Lambert, Céline, Lambert, Claude, Lemouel, Vincent, Jouaville, Lionel, Jubin, Virginie, Malifarge, Elise, Maridet, Sarah, Minet, Perrine, Montmaneix, Nathalie, Moutou, Aurelie, Petit, Isabelle, Rolland, Emmanuelle, Rougé, Pierre, Sablayrolles, Virginie, Subervie, Adrien, Tardieu, Cecile, Trraf, Hibatullahi, Usclade, Alexandra
Format: Journal Article
Language:English
Published: England Wiley Subscription Services, Inc 01-07-2018
Wiley
Subjects:
adolescent
Adolescents
Anaphylaxis
capsules
Desensitization
Double-blind studies
Dysphagia
Esophagitis
Food and Nutrition
gastrointestinal delivery
Gastrointestinal tract
Hypersensitivity
Immune response (humoral)
Immunological tolerance
Immunology
Immunotherapy
Ingestion
Leukocytes (eosinophilic)
Life Sciences
Motivation
oral immunotherapy
Patients
peanut allergy
Randomization
Teenagers
peanut allergy
adolescent
anaphylaxis
gastrointestinal delivery
oral immunotherapy
capsules
allergie alimentaire
cacahuete
peanut
food sensitivity
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Summary:Summary Background Oral immunotherapy to peanut is effective in desensitizing patients but has significant side effects including anaphylaxis and gastrointestinal symptoms. In most protocols, peanut is administered in a vehicle food. Objective In an exclusively adolescent population, we tested a new approach using sealed capsules of peanut (gastrointestinal delivery oral immunotherapy or GIDOIT) to bypass the upper gastrointestinal tract. The primary aim was to assess the efficacy of the oral build‐up phase of GIDOIT and the secondary aim to analyse its safety. Methods Adolescents with a history of a clinical allergic reaction after peanut ingestion were included in a 2‐armed, parallel‐design, individually randomized, double‐blind, placebo‐controlled, multicentre trial after a positive double‐blind placebo‐controlled oral food challenge (DBPCFC1). A central randomization centre used computer‐generated tables to allocate treatments. Peanut (or placebo) capsules were ingested daily over a period of 24 weeks with increments every 2 weeks from 2 to 400 mg of peanut protein (pp). Primary outcome was tolerance of 400 mg of pp at DBPCFC2. Results Thirty patients were included between September 2013 and May 2014. At DBPCFC2, unresponsiveness to 400 mg of pp was achieved in 17/21 peanut group patients (2 withdrawn patients) and 1/9 in the placebo group (Intention‐to‐treat analysis, P < .001, absolute difference = 0.7, 95%IC 0.43 0.96). Oropharyngeal symptoms were equally frequent in both groups. No dysphagia or other signs of eosinophilic oesophagitis occurred. Digestive adverse events (AE) were more frequent in the treated group (P = .02), but mild and without compliance issues. Only one severe advent event led to withdrawal in a patient who ingested twice the investigated treatment. Peanut‐specific humoral immune responses were modulated. Conclusion The GIDOIT protocol demonstrated clinical and immunological efficacy and had an acceptable level of safety with weak oropharyngeal symptoms, no dysphagia, mild digestive events and few severe systemic AE.
Bibliography:ObjectType-Article-2
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ISSN:0954-7894
1365-2222
DOI:10.1111/cea.13148