Evidence map›Paper›PMID 34320250›Full record

Trial reportAllergy2022

Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy.

Montserrat Fernandez-Rivas, Andrea Vereda, Brian P Vickery, Vibha Sharma, Caroline Nilsson, Antonella Muraro, Jonathan O'B Hourihane, Audrey DunnGalvin, George du Toit, Katharina Blumchen and 5 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Allergy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Dosing Reactions and Missed Doses Affect Peanut Oral Immunotherapy Outcomes.The journal of allergy and clinical immunology. In practice · 2026
    Trial
  6. Sex assigned at birth may modify health-related quality of life in children treated with peanut oral immunotherapy.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2025
    Trial
  7. Trial
  8. Article
  9. Article
  10. Article
  11. Review
  12. Observational
  13. Article
  14. Article
  15. Recent advances in food allergen immunotherapy.Clinical and experimental pediatrics · 2024
    Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Review
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

15 authors.

Montserrat Fernandez-RivasAllergy Department, Hospital Clinico San Carlos, IdISSC, Madrid, Spain.ORCID 0000-0003-1748-2328
Andrea VeredaAimmune Therapeutics, London, UK.
Brian P VickeryEmory University School of Medicine, Atlanta, Georgia, USA.
Vibha SharmaDepartment of Paediatric Allergy and Immunology, Royal Manchester Children's Hospital, Manchester, UK.
Caroline NilssonClinical Science and Education, Södersjukhuset, Karolinska Institutet, Sachs' Children and Youth Hospital, Stockholm, Sweden.
Antonella MuraroFood Allergy Referral Centre Veneto Region, Department of Woman and Child Health, Padua University Hospital, Padua, Italy.
Jonathan O'B HourihanePaediatrics and Child Health, Royal College of Surgeons in Ireland, Dublin, Ireland.
Audrey DunnGalvinInfant Centre and Pediatrics and Child Health, University College Cork, and HRB Clinical Research Facility-Cork, Cork, Ireland.ORCID 0000-0002-1540-3959
George du ToitGuy's and St. Thomas' NHS Foundation Trust, London, UK.ORCID 0000-0002-0321-2928
Katharina BlumchenDivision of Allergology, Pneumology and Cystic Fibrosis, Department of Children and Adolescent Medicine, Goethe University Frankfurt, Frankfurt, Germany.
Kirsten BeyerDivision of Pulmonology, Immunology and Critical Care Medicine, Department of Pediatrics, Charité Universtãtsmedizin Berlin, Berlin, Germany.
Alex SmithAimmune Therapeutics, Brisbane, California, USA.
Robert RyanAimmune Therapeutics, London, UK.ORCID 0000-0003-0827-3153
Daniel C AdelmanAimmune Therapeutics, Brisbane, California, USA.
Stacie M JonesUniversity of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Arkansas, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe benefit of daily administration of Peanut (Arachis hypogaea) Allergen Powder-dnfp (PTAH)-formerly AR101-has been established in clinical trials, but limited data past the first year of treatment are available. This longitudinal analysis aimed to explore the impact of continued PTAH therapeutic maintenance dosing (300 mg/day) on efficacy, safety/tolerability, and food allergy-related quality of life.

methodsWe present a subset analysis of PALISADE-ARC004 participants (aged 4-17 years) who received 300 mg PTAH daily for a total of ~1.5 (Group A, n = 110) or ~2 years (Group B, n = 32). Safety assessments included monitoring the incidence of adverse events (AEs), accidental exposures to food allergens, and adrenaline use. Efficacy was assessed by double-blind, placebo-controlled food challenge (DBPCFC); skin prick testing; peanut-specific antibody assays; and Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) scores.

resultsContinued maintenance with PTAH increased participants' ability to tolerate peanut protein: 48.1% of completers in Group A (n = 50/104) and 80.8% in Group B (n = 21/26) tolerated 2000 mg peanut protein at exit DBPCFC without dose-limiting symptoms. Immune biomarkers showed a pattern consistent with treatment-induced desensitization. Among PTAH-continuing participants, the overall and treatment-related exposure-adjusted AE rate decreased throughout the intervention period in both groups. Clinically meaningful improvements in FAQLQ and FAIM scores over time suggest a potential link between increased desensitization as determined by the DBPCFC and improved quality of life.

conclusionsThese results demonstrate that daily PTAH treatment for peanut allergy beyond 1 year leads to an improved safety/tolerability profile and continued clinical and immunological response.

Indexed as

Food HypersensitivityPeanut HypersensitivityAdministration, OralAdolescentAllergensArachisChildChild, PreschoolDesensitization, ImmunologicHumansImmunologic FactorsQuality of LifeAllergensImmunologic Factorsdesensitizationfood allergyoral immunotherapypeanut allergyquality of life

Identifiers

PMID34320250
PMCPMC9293305

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Registered trials

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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.