Evidence map›Paper›PMID 37240667›Full record

ArticleJournal of clinical medicine2023

Why a Complete Response Is the Treatment Aim in Chronic Spontaneous Urticaria.

Jonathan A Bernstein, Ana Giménez-Arnau, Marcus Maurer, Petra Staubach, Nathalie Barbier, Eva Hua, Thomas Severin, Pedro A Laires, Maria-Magdalena Balp

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02477332 (A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT02477332 phase2completednot on this map

A Multi-center, Randomized, Double-blind, Placebo, and Active-controlled Phase 2b Dose-finding Study of QGE031 as add-on Therapy to Investigate the Efficacy and Safety in Patients With Chronic Spontaneous Urticaria (CSU)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2017Enrolled382ConditionsChronic Spontaneous UrticariaArmsQGE031, Omalizumab, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. 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

9 authors at 6 institutions in 6 countries.

Jonathan A BernsteinDivision of Rheumatology, Bernstein Allergy Group and Clinical Research Center, College of Medicine, University of Cincinnati, Cincinnati, OH 45267, USA.ORCID 0000-0002-3476-1196
Ana Giménez-ArnauDermatology Department, Hospital del Mar, IMIM, Universitat Pompeu Fabra, 08005 Barcelona, Spain.ORCID 0000-0001-5434-7753
Marcus MaurerInstitute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, 12203 Berlin, Germany.ORCID 0000-0002-4121-481X
Petra StaubachDepartment of Dermatology, University Medical Center Mainz, 55131 Mainz, Germany.
Nathalie BarbierNovartis Pharma AG, 4002 Basel, Switzerland.
Eva HuaChina Novartis Institutes for Biomedical Research Co., Ltd., Shanghai 201203, China.
Thomas SeverinNovartis Pharma AG, 4002 Basel, Switzerland.
Pedro A LairesNovartis Pharma AG, 4002 Basel, Switzerland.
Maria-Magdalena BalpNovartis Pharma AG, 4002 Basel, Switzerland.
Novartis (Switzerland) · CHBernstein Clinical Research Center · USHumboldt-Universität zu Berlin · DEJohannes Gutenberg University Mainz · DENovartis (China) · CNUniversitat Pompeu Fabra · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study investigated the association between urticaria activity and health-related quality of life (HRQoL). Patient evaluations from the ligelizumab Phase 2b clinical trial (N = 382) were pooled (NCT02477332). Daily patient diaries assessed urticaria activity, sleep and activity interference, the dermatology life quality index (DLQI), and work productivity and activity impairment-chronic urticaria (WPAI-CU). The number of DLQI scores, weekly sleep interference scores (SIS7), weekly activity interference scores (AIS7), and overall work impairment (OWI) evaluations with a complete response per weekly urticaria activity score (UAS7) using bands (0, 1-6, 7-15, 16-27, and 28-42) were reported. Over 50% of the patients had a mean DLQI of > 10 at baseline, indicating a significant effect of chronic spontaneous urticaria (CSU) on their HRQoL. Complete response (UAS7 = 0) evaluations corresponded with no impacts on other patient-reported outcomes. In total, 91.1% of UAS7 = 0 evaluations corresponded to DLQI scores of 0-1, 99.7% to SIS7 scores of 0, 99.7% to AIS7 scores of 0, and 85.3% to OWI scores of 0. This was significantly different compared with the UAS7 = 1-6 evaluations (61.9%, 68.5%, 67.7%, and 65.4%, respectively;

Indexed as

chronic spontaneous urticariacomplete responsepatient-reported outcomesquality of lifesleep

Identifiers

PMID37240667
PMCPMC10219198
OpenAlexW4377091395

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.