Evidence map›Paper›PMID 41319902›Full record

ArticleThe journal of allergy and clinical immunology. In practice2026

Biopredictors for Omalizumab Response in Patients With Chronic Spontaneous Urticaria.

Megan Le, Tara McCaffrey, Li Gao, Sarbjit Saini

Abstract read
In one paragraph

Article in The journal of allergy and clinical immunology. In practice, 2026. 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
–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

3 citing papers in PubMed.

  1. 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
  2. Systemic Treatments for Chronic Spontaneous Urticaria: Anti-IgE and Beyond.The journal of allergy and clinical immunology. In practice · 2026
    Review
  3. 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

4 authors.

Megan LeDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Tara McCaffreyDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Li GaoDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md.
Sarbjit SainiDivision of Allergy and Clinical Immunology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Md. Electronic address: ssaini@jhmi.edu.

Funding

Genetic Control of the SYK Tyrosine-protein Kinase in AllergyR01AI181867 · NIAID · JOHNS HOPKINS UNIVERSITY · PI LI GAO · 2024 to 2026
$1.7M
NIAID NIH HHS R01 AI181867
6 · The paper itself

Abstract

backgroundProposed negative biopredictors of omalizumab response in patients with chronic spontaneous urticaria are low baseline IgE (≤40 IU/mL), positive CU Index (CUI) test result, and basopenia defined by blood histamine content (BHC) (≤8 ng/mL).

objectiveTo test the hypothesis that patients with these negative biopredictors will have a poorer response to omalizumab.

methodsWe performed a retrospective analysis of 3 phase III studies of antihistamine-refractory subjects with chronic spontaneous urticaria who received omalizumab 300 mg every 4 weeks for 12 weeks. The relationship between baseline biopredictors and subjects with excellent symptom control measured by Urticaria Activity Score over 7 days (UAS7 ≤ 6) or poor symptom control (UAS7 > 6) after 12 weeks was examined. We performed χ

resultsIn 363 subjects, data were available for IgE and CUI; 266 had BHC measures. Subjects with UAS7 higher than 6 at 12 weeks significantly more often expressed a baseline negative biopredictor: IgE level less than or equal to 40 IU/mL (n = 109 [50%]) versus IgE level more than 40 IU/mL (n = 239 [33%]); CUI positive (n = 98 [55%]) versus negative (n = 263 [32%]); BHC less than 8 ng/mL (n = 64 [55%]) versus BHC more than 8 ng/mL (n = 202 [33%]). CUI positivity significantly predicted a UAS7 higher than 6 at 12 weeks (P = .0002; odds ratio, 2.54; 95% CI, 1.55-4.15). According to receiver-operating characteristic curve analysis, a BHC of 6.4 ng/mL was distinguishing nonresponders from responders. Among subjects with low baseline IgE, the presence of low BHC was predictive for nonresponsiveness to omalizumab (χ

conclusionsSubjects with positive CUI, low BHC, or both low IgE and BHC have an increased likelihood of poorer response to omalizumab at 12 weeks.

Indexed as

Anti-Allergic AgentsChronic UrticariaHistamineOmalizumabAdultAgedFemaleHumansImmunoglobulin EMaleMiddle AgedRetrospective StudiesTreatment OutcomeYoung AdultAnti-Allergic AgentsHistamineImmunoglobulin EOmalizumabBiopredictorsOmalizumabUrticaria

Identifiers

PMID41319902
PMCPMC13656462

What OpenQuestion holds

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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.