Evidence map›Paper›PMID 34890827›Full record

Trial reportThe journal of allergy and clinical immunology. In practice2022

Maximum Dose Food Challenges Reveal Transient Sustained Unresponsiveness in Peanut Oral Immunotherapy (POIMD Study).

Carla M Davis, Aikaterini Anagnostou, Sridevi Devaraj, Daisy T Vita, Fabian Rivera, Kathleen Pitts, Melissa Hearrell, Charles Minard, Danielle Guffey, Meera Gupta and 3 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The journal of allergy and clinical immunology. In practice, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% of its field
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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. 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

13 authors at 4 institutions in 1 country.

Carla M DavisDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas. Electronic address: carlad@bcm.edu.
Aikaterini AnagnostouDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Sridevi DevarajBaylor College of Medicine, Texas Children's Hospital, Department of Pathology and Immunology, Houston, Texas.
Daisy T VitaDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Fabian RiveraDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Kathleen PittsDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Melissa HearrellDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Charles MinardDan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas.
Danielle GuffeyDan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas.
Meera GuptaDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Levi WatkinDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Jordan S OrangeColumbia University, Vagelos College of Physicians and Surgeons, New York-Presbyterian, Morgan Stanley Children's Hospital, New York, NY.
Sara AnvariDepartment of Pediatrics, Baylor College of Medicine, Houston, Texas; Texas Children's Hospital, Section of Immunology, Allergy and Retrovirology, Houston, Texas.
Baylor College of Medicine · USTexas Children's Hospital · USHouston Institute for Clinical Research · USMorgan Stanley Children's Hospital · US

Funding

Safety and Tolerability of Shrimp Oral Immunotherapy in Shrimp Allergic SubjectsR34AI157948 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI DAVIS, CARLA M. · 2021 to 2021
$313k
NIAID NIH HHS R34 AI157948
6 · The paper itself

Abstract

backgroundThe maximum tolerated dose of peanut protein following peanut oral immunotherapy (POIT) is unknown because most research studies have not examined very high thresholds.

objectiveTo define the maximum dose tolerated by patients on POIT and severity of allergic reactions after a 1-month period of treatment discontinuation.

methodsIn a phase 2 3-year POIT open-label study, we enrolled participants age 5 to 13 years with a 1-year build-up period followed by a 2-year daily maintenance dose of 3900 mg with assessment of the maximum tolerated dose using double-blind placebo-controlled food challenges (DBPCFCs) of 26,225 mg cumulative dose of peanut protein. The DBPCFC was performed at baseline, after 12-month build-up, at 2 year of maintenance, and after a 1-month period of treatment discontinuation. Biomarkers were assessed every 6 weeks for the first 6 months of therapy. A general linear mixed model was used for analysis.

resultsThe mean maximum cumulative tolerated dose after 12 months increased by 12,063 mg (P < .001) (n = 12), slightly decreased during maintenance (n = 11), and significantly decreased by 7593 mg after avoidance for 1 month (P = .03) (n = 6). Biomarker analysis revealed decreases in cytokine expression within the first 6 weeks of initiation of POIT and decreased peanut-IgG

conclusionsThe evaluation of POIT and sustained unresponsiveness by maximum tolerated dose by DBPCFCs in this small phase 2 trial showed that desensitization is diminished, with 100% loss of tolerated dose after 1 month of avoidance following 3 years of treatment.

Indexed as

ArachisPeanut HypersensitivityAdministration, OralAdolescentAllergensChildChild, PreschoolDesensitization, ImmunologicHumansAllergensAdverse eventsAra h 2BiomarkerCytokine expressionDouble-blind placebo-controlled food challengeOutcomesPeanut oral immunotherapyPeanut-specific IgEPeanut-specific IgG(4)Sustained unresponsivenessTolerance

Identifiers

PMID34890827
PMCPMC10404846
OpenAlexW4200081648

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.