Evidence map›Paper›PMID 39066978›Full record

ArticleDermatology and therapy2024

Dupilumab Reduces Urticaria Activity, Itch, and Hives in Patients with Chronic Spontaneous Urticaria Regardless of Baseline Serum Immunoglobulin E Levels.

Marcus Maurer, Thomas B Casale, Sarbjit S Saini, Moshe Ben-Shoshan, Elizabeth Laws, Jennifer Maloney, Deborah Bauer, Allen Radin, Melanie Makhija

Registry-linked trialAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04180488 (Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

NCT04180488 phase3completednot on this map

Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab

TypeinterventionalSponsorSanofiRan2019 to 2024Enrolled397ConditionsChronic Spontaneous UrticariaArmsDupilumab SAR231893, Placebo, non sedating H1-antihistamine
3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Observational
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
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  12. 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
  13. Omalizumab to dupilumab switch in chronic spontaneous urticaria.The World Allergy Organization journal · 2025
    Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. 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

9 authors.

Marcus MaurerInstitute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Free University of Berlin and Humboldt-University of Berlin, Hindenburgdamm 27, 12203, Berlin, Germany. marcus.maurer@charite.de.ORCID http://orcid.org/0000-0002-4121-481X
Thomas B CasaleDivision of Allergy and Immunology, University of South Florida, Tampa, FL, USA.
Sarbjit S SainiJohns Hopkins Asthma and Allergy Center, Baltimore, MD, USA.
Moshe Ben-ShoshanDivision of Allergy/Immunology/Dermatology, Department of Pediatrics, McGill University Health Centre, Montreal, QC, Canada.
Elizabeth LawsSanofi, Bridgewater, NJ, USA.
Jennifer MaloneyRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Deborah BauerSanofi, Bridgewater, NJ, USA.
Allen RadinRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Melanie MakhijaSanofi, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn chronic spontaneous urticaria (CSU), interleukin (IL)-4 and IL-13 may promote mast cell activation directly via IL-4 receptor expression, or indirectly via upregulated immunoglobulin E (IgE) production. Dupilumab significantly improved CSU signs and symptoms in the phase 3, randomized, placebo-controlled LIBERTY-CSU CUPID Study A. This analysis explores the impact of dupilumab on CSU signs and symptoms and serum IgE levels in patients from LIBERTY-CSU CUPID Study A with serum total IgE above and below 100 IU/mL at baseline.

methodsPatients with H1-antihistamine-refractory CSU received dupilumab (n = 70) or placebo (n = 68) for 24 weeks. Efficacy endpoints were change from baseline to weeks 12 and 24 in serum total IgE levels, Itch Severity Score over 7 days (ISS7), Urticaria Activity Score over 7 days (UAS7), and Hives Severity Score over 7 days (HSS7) in dupilumab- or placebo-treated patients with serum total IgE above and below 100 IU/mL at baseline.

resultsDupilumab treatment significantly reduced median (interquartile range) IgE levels at week 12 [dupilumab: -31.9% (-41.9; -22.6); placebo: -6.3% (-21.3; 14.9)] and week 24 [dupilumab: -48.2% (-56.8; - 39.5); placebo: - 6.3% (-34.5; 14.8)]. Similar IgE reductions relative to baseline were observed in dupilumab-treated patients regardless of baseline IgE level. Dupilumab treatment improved ISS7, UAS7, and HSS7 over 12 and 24 weeks, regardless of baseline serum IgE level (interaction p ≥ 0.59 for all treatment by subgroup comparisons), with weak correlations (r < 0.2) observed between IgE level changes and ISS7, UAS7, and HSS7 outcomes.

conclusionsDupilumab significantly improved CSU signs and symptoms and reduced serum IgE, regardless of baseline IgE levels. In the current analysis, baseline total IgE had no predictive value as a dupilumab treatment response biomarker in CSU. Downregulation of IgE, a key mediator of mast cell activation and histamine release, may at least partially explain the effectiveness of dupilumab in reducing CSU signs and symptoms.

trial registrationClinicalTrials.gov Identifier: NCT04180488.

Indexed as

BiomarkerChronic spontaneous urticariaCSUDupilumabIgEImmunoglobulin EOmalizumab-naïveType 2 inflammation

Identifiers

PMID39066978
PMCPMC11393262

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.