Evidence map›Paper›PMID 38282192›Full record

ArticleClinical and translational allergy2024

Exploratory immunogenicity outcomes of peanut oral immunotherapy: Findings from the PALISADE trial.

Caroline Nilsson, Andrea Vereda, Magnus P Borres, Mats Andersson, Eva Södergren, Magnus Rudengren, Alex Smith, Reyna J Simon, Robert Ryan, Montserrat Fernández-Rivas and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Clinical and translational allergy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02635776 (Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02635776 phase3completednot on this map

Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE)

TypeinterventionalSponsorAimmune Therapeutics, Inc.Ran2015 to 2018Enrolled555ConditionsPeanut AllergyArmsAR101 powder provided in capsules & sachets, Placebo powder provided in capsules & sachets
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Caroline NilssonClinical Research and Education, Karolinska Institutet, Sachs' Children and Youth Hospital, Stockholm, Sweden.
Andrea VeredaAimmune Therapeutics, a Nestlé Health Science Company, London, UK.
Magnus P BorresKarolinska University Hospital, Stockholm, Sweden.
Mats AnderssonThermo Fisher Scientific, Uppsala, Sweden.
Eva SödergrenThermo Fisher Scientific, Uppsala, Sweden.
Magnus RudengrenThermo Fisher Scientific, Uppsala, Sweden.
Alex SmithAimmune Therapeutics, a Nestlé Health Science Company, Brisbane, California, USA.
Reyna J SimonCalico Life Sciences, South San Francisco, California, USA.
Robert RyanAimmune Therapeutics, a Nestlé Health Science Company, London, UK.
Montserrat Fernández-RivasAllergy Department, Hospital Clínico San Carlos, Madrid, Spain.
Daniel AdelmanAimmune Therapeutics, a Nestlé Health Science Company, Brisbane, California, USA.
Brian P VickeryEmory University School of Medicine-Pediatrics, Atlanta, Georgia, USA.

Funding

Aimmune Therapeutics, a Nestlé Health Science companyThermo Fisher Scientific
6 · The paper itself

Abstract

backgroundImmunoglobulin E (IgE) and immunoglobulin G4 (IgG4) to peanut and its components may influence the clinical reactivity to peanut. Allergen-specific immunotherapy is known for modifying both IgE and IgG4. Peanut oral immunotherapy may influence these serological parameters.

methodsExploratory analyses of serological data from participants receiving peanut (Arachis hypogaea) allergen powder-dnfp (PTAH) and placebo in the double-blind, randomized, phase 3 PALISADE trial were conducted to evaluate potential relationships between peanut-specific and peanut component-specific (Ara h 1, Ara h 2, Ara h 3, Ara h 6, Ara h 8, and Ara h 9) IgE and IgG4 levels and clinical outcomes.

resultsA total of 269 participants (PTAH, n = 202; placebo, n = 67) were analyzed. No relationship was observed between specific IgE and IgG4 levels at screening and maximum tolerated peanut protein dose during screening or response status during exit double-blind placebo-controlled food challenge (DBPCFC). In PTAH-treated participants, no relationship was observed between IgE and IgG4 levels at screening and maximum symptom severity during exit DBPCFC. Postscreening ratios (ie, postscreening/screening) in the PTAH group were significant at the end of updosing and exit visit for most components. Postscreening changes in specific IgE levels were more pronounced with PTAH versus placebo for most components.

conclusionsSpecific IgE and IgG4 levels at screening are not correlated with screening or exit DBPCFC results, and are not predictive of clinical response to PTAH. Peanut (Arachis hypogaea) allergen powder-dnfp contains the relevant and immunodominant allergens, inducing immunological changes with the treatment. CLINICAL

trial registrationClinicalTrials.gov identifier: NCT02635776.

Indexed as

immunoglobulinoral immunotherapypeanutpeanut allergyserology

Identifiers

PMID38282192
PMCPMC10793676

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.