Evidence map›Paper›PMID 33713769›Full record

ArticleThe Journal of allergy and clinical immunology2021

The efficacy of omalizumab treatment in chronic spontaneous urticaria is associated with basophil phenotypes.

Kirti J Johal, Kristin L Chichester, Eric T Oliver, Kelly C Devine, Anja P Bieneman, John T Schroeder, Donald W MacGlashan, Sarbjit S Saini

Registry-linked trialOpen access · greenAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Journal of allergy and clinical immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03111628 (Role of Immunoglobulin E), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
4.4field-weighted citation impact, top 5% 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.

NCT03111628 phase4completednot on this map

Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria

TypeinterventionalSponsorJohns Hopkins UniversityRan2017 to 2020Enrolled18ConditionsUrticaria ChronicArmsOmalizumab
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 34 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Emerging IgE and non-IgE targeted therapies for chronic urticaria.Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2026
    Review
  5. Biopredictors for Omalizumab Response in Patients With Chronic Spontaneous Urticaria.The journal of allergy and clinical immunology. In practice · 2026
    Article
  6. Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond.The journal of allergy and clinical immunology. In practice · 2026
    Review
  7. Article
  8. Towards Personalised Therapy in Chronic Spontaneous Urticaria: Advancing From Endotype to Clinical Response.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2025
    Review
  9. Article
  10. Chronic Spontaneous Urticaria: Etiology and Pathogenesis.Immunology and allergy clinics of North America · 2024
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. The Potential Role of Basophils in Urticaria.Frontiers in immunology · 2022
    Review
  19. Frontiers in medicine · 2022
    Article
  20. 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

8 authors at 2 institutions in 1 country.

Kirti J JohalDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md; Division of Allergy and Immunology, Department of Medicine, George Washington University School of Medicine and Health Sciences, Washington, DC.
Kristin L ChichesterDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Eric T OliverDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Kelly C DevineDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Anja P BienemanDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
John T SchroederDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Donald W MacGlashanDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Sarbjit S SainiDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md. Electronic address: ssaini@jhmi.edu.
Johns Hopkins Medicine · USJohns Hopkins University · US

Funding

Human DC Subtypes in Regulating T-Helper-2 ResponsesR01AI115703 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SCHROEDER, JOHN T. · 2015 to 2019
$2.0M
Regulation of Syk Expression in Human BasophilsR01AI163043 · NIAID · JOHNS HOPKINS UNIVERSITY · PI MACGLASHAN, DONALD W · 2021 to 2024
$1.6M
Role of IgE Bearing Cells in Chronic Idiopathic UrticariaR01AI116658 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SAINI, SARBJIT SINGH · 2016 to 2018
$1.4M
NIAID NIH HHS R01 AI115703NIAID NIH HHS R01 AI116658NIAID NIH HHS R01 AI163043
6 · The paper itself

Abstract

backgroundThe mechanisms underlying disease pathogenesis in chronic spontaneous urticaria (CSU) and improvement with omalizumab are incompletely understood.

objectivesThis study sought to examine whether the rate of clinical remission is concordant with baseline basophil features or the rate of change of IgE-dependent functions of basophils and/or plasmacytoid dendritic cells during omalizumab therapy.

methodsAdults (n = 18) with refractory CSU were treated with omalizumab 300 mg monthly for 90 days. Subjects recorded daily urticaria activity scores, and clinical assessments with blood sampling occurred at baseline and on days 1, 3, 6, 10, 20, 30, 60, and 90 following omalizumab. At baseline, subjects were categorized by basophil functional phenotypes, determined by in vitro histamine release (HR) responses to anti-IgE antibody, as CSU-responder (CSU-R) or CSU-non-responder (CSU-NR), as well as basopenic (B) or nonbasopenic (NB).

resultsCSU-R/NB subjects demonstrated the most rapid and complete symptom improvement. By day 6, CSU-R/NB and CSU-NR/NB had increased anti-IgE-mediated basophil HR relative to baseline, and these shifts did not correlate with symptom improvement. In contrast, CSU-NR/B basophil HR did not change during therapy. The kinetics of the decrease in surface IgE/FcεRI was similar in all 3 phenotypic groups and independent of the timing of the clinical response. Likewise, plasmacytoid dendritic cells' surface IgE/FcεRI decline and TLR9-induced IFN-α responses did not reflect clinical change.

conclusionsChanges in basophil IgE-based HR, surface IgE, or FcεRI bear no relationship to the kinetics in the change in clinical symptoms. Baseline basophil count and basophil functional phenotype, as determined by HR, may be predictive of responsiveness to omalizumab.

Indexed as

Anti-Allergic AgentsBasophilsBiomarkersChronic DiseaseChronic UrticariaDendritic CellsHistamine ReleaseHumansImmunoglobulin EOmalizumabPhenotypeTime FactorsTreatment OutcomeAnti-Allergic AgentsBiomarkersImmunoglobulin EOmalizumabBasophilbasophil activation testchronic spontaneous urticariaFcεRIhistamine releaseIgEomalizumabplasmacytoid dendritic cell

Identifiers

PMID33713769
PMCPMC8223444
OpenAlexW3135743637

What OpenQuestion holds

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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.