Evidence map›Paper›PMID 29221713›Full record

Trial reportThe Journal of allergy and clinical immunology2018

Effect of grass sublingual tablet immunotherapy is similar in children and adults: A Bayesian approach to design pediatric sublingual immunotherapy trials.

Amarjot Kaur, David Skoner, Joseph Ibrahim, Qing Li, Richard F Lockey, Michael Blaiss, Albrecht Bufe, Jens Strodl Andersen, Giorgio Walter Canonica, Hendrik Nolte

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of allergy and clinical immunology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 20% 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

3 citing papers in PubMed, 14 citations in OpenAlex.

  1. Asia Pacific allergy · 2025
    Article
  2. EAACI Allergen Immunotherapy User's Guide.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2020
    Review
  3. Optimizing Clinical Trial Design to Maximize Evidence Generation in Pediatric HIV.Journal of acquired immune deficiency syndromes (1999) · 2018
    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

10 authors at 8 institutions in 4 countries.

Amarjot KaurMerck, Kenilworth, NJ.
David SkonerDepartment of Pediatrics, West Virginia University School of Medicine, Morgantown, WV.
Joseph IbrahimDepartment of Biostatistics, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC.
Qing LiMerck, Kenilworth, NJ.
Richard F LockeyDivision of Allergy and Immunology, University of South Florida Morsani College of Medicine, Tampa, Fla.
Michael BlaissDepartment of Pediatrics, Medical College of Georgia, Augusta, Ga.
Albrecht BufeDepartment of Experimental Pneumology, Ruhr-University Bochum, Bochum, Germany.
Jens Strodl AndersenALK-Abelló, Hørsholm, Denmark.
Giorgio Walter CanonicaPersonalized Medicine Clinic Asthma & Allergy, Humanitas University & Research Hospital, Milan, Italy.
Hendrik NolteMerck, Kenilworth, NJ. Electronic address: Hendrik.nolte@alk.net.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USALK-Abelló (Denmark) · DKAugusta University · USHumanitas University · ITRuhr University Bochum · DEUniversity of North Carolina at Chapel Hill · USUniversity of South Florida · USWest Virginia University · US

Funding

Statistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI TSIATIS, ANASTASIOS A · 2010 to 2019
$21.3M
NCI NIH HHS P01 CA142538
6 · The paper itself

Abstract

backgroundLarge sample sizes are needed for sublingual immunotherapy (SLIT) trials because of inherent data variability secondary to inconsistent allergen exposure. Obtaining large sample sizes for pediatric SLIT trials is challenging, but a Bayesian approach using prior adult data can reduce the necessary sample size.

objectiveWe sought to describe how a Bayesian framework using prior information from adult trials can be used to improve pediatric SLIT clinical development.

methodsData were compiled by using a frequentist approach (conventional clinical trial approach independent of prior data) from trials conducted during the clinical development of timothy grass SLIT-tablets.

resultsThe treatment effect of timothy grass SLIT-tablets was considered similar between pediatric (n = 795) and adult (n = 2299) data pools, with relative total combined symptom plus medication score improvement versus placebo of 21% (95% CI, 11.0% to 30.4%) and 20% (95% CI, 14.6% to 24.4%), respectively. Phleum pratense-specific IgG

conclusionsData support the similarity of efficacy and immunologic changes between children and adults treated with SLIT for allergic rhinoconjunctivitis. Therefore it is appropriate to use data from adult trials to design feasible trials in children, which might reduce unsafe off-label use by promoting more quickly proper labeling of approved products.

Indexed as

Administration, SublingualAdolescentAdultAllergensBayes TheoremDouble-Blind MethodFemaleHumansHypersensitivityImmunoglobulin EImmunoglobulin GMalePhleumSublingual ImmunotherapyTabletsAllergensImmunoglobulin EImmunoglobulin GTabletsadultsBayesian frameworkchildrenefficacyfrequentistIgG(4)Sublingual immunotherapytrial design

Identifiers

PMID29221713
PMCPMC7844553
OpenAlexW2771302239

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.