Evidence map›Paper›PMID 29058822›Full record

Trial reportAllergy2018

Omalizumab rapidly improves angioedema-related quality of life in adult patients with chronic spontaneous urticaria: X-ACT study data.

P Staubach, M Metz, N Chapman-Rothe, C Sieder, M Bräutigam, M Maurer, K Weller

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Allergy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% 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

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Pooled it
  2. Comparative efficacy and safety of the treatment by Omalizumab for chronic idiopathic urticaria in the general population: A systematic review and network meta-analysis.Skin research and technology : official journal of International Society for Bioengineering and the Skin (ISBS) [and] International Society for Digital Imaging of Skin (ISDIS) [and] International Society for Skin Imaging (ISSI) · 2024
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. A Patient Charter for Chronic Urticaria.Advances in therapy · 2024
    Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Anti-IgE for the Treatment of Chronic Urticaria.ImmunoTargets and therapy · 2021
    Review
  20. 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

7 authors at 4 institutions in 2 countries.

P StaubachDepartment of Dermatology, University Medical Center Mainz, Mainz, Germany.
M MetzDepartment of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.
N Chapman-RotheNovartis Pharma AG, Basel, Switzerland.
C SiederNovartis Pharma GmbH, Nuernberg, Germany.
M BräutigamNovartis Pharma GmbH, Nuernberg, Germany.
M MaurerDepartment of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-4121-481X
K WellerDepartment of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-4437-0313
Charité - Universitätsmedizin Berlin · DENovartis (Germany) · DEJohannes Gutenberg University Mainz · DENovartis (Switzerland) · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe X-ACT study aimed to examine the effect of omalizumab treatment on quality of life (QoL) in chronic spontaneous urticaria (CSU) patients with angioedema refractory to high doses of H

methodsIn X-ACT, a phase III, double-blind, placebo-controlled study, CSU patients (18-75 years) with ≥4 angioedema episodes during the 6 months before inclusion were randomized (1:1) to receive omalizumab 300 mg or placebo every 4 weeks for 28 weeks. Angioedema-related QoL, skin-related QoL impairment, and psychological well-being were assessed.

resultsNinety-one patients were randomized and 68 (omalizumab, n = 35; placebo, n = 33) completed the 28-week treatment period. At baseline, the mean (SD) total Angioedema QoL (AE-QoL; 56.2 [18.7] and 59.9 [19.2]) and Dermatology Life Quality Index (DLQI; 14.6 [5.7] and 16.6 [7.3]) score were high in the omalizumab and placebo group, respectively. At Week 4 (after the first treatment), the least squares mean difference in the AE-QoL and DLQI score between groups was -17.6 (P < .001) and -7.2 (P < .001), respectively. Significant QoL improvements in the omalizumab vs placebo groups continued until Week 28, but returned to placebo levels at the follow-up visit. The mean (SD) baseline 5-item World Health Organization Well-being Index was 10.0 (5.5, omalizumab) and 7.7 (5.3, placebo), which increased above the depression threshold (<13) from Week 4 and throughout with omalizumab but not placebo treatment. Compared to placebo, omalizumab was also associated with decreased fear of suffocation due to angioedema.

conclusionsOur findings support omalizumab treatment in patients with severe H1-antihistamine-refractory CSU with angioedema.

Indexed as

Quality of LifeAdolescentAdultAgedAngioedemaAnti-Allergic AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedOmalizumabUrticariaYoung AdultAnti-Allergic AgentsOmalizumabangioedemachronic spontaneous urticariaH1-antihistamine-refractoryomalizumabquality of life

Identifiers

PMID29058822
PMCPMC5836932
OpenAlexW2766150186

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.