Cited by 66Urticaria and Related ConditionsMast cells and histamineEosinophilic Disorders and Syndromes

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

Open access
Staubach, P., Metz, M., Chapman‐Rothe, N., Sieder, C., Bräutigam, M., Maurer, M., Weller, K.·2018·Allergy

Abstract

Background: The 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 1‐antihistamines. Methods: In 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. Results: Ninety‐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. Conclusions: Our findings support omalizumab treatment in patients with severe H1‐antihistamine‐refractory CSU with angioedema.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1111/all.13339

Cites

31 of 31 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Authors
Staubach, P., Metz, M., Chapman‐Rothe, N., Sieder, C., Bräutigam, M., Maurer, M., & Weller, K.
Affiliations
  • University Medical Center of the Johannes Gutenberg University Mainz (DE)
  • Charité – Universitätsmedizin Berlin (DE)
  • Novartis (Switzerland) (CH)
  • Novartis (Germany) (DE)
Corresponding author
Weller, K.
Venue
Allergy
Publisher
Wiley
Published
2017-12-11
Volume
73
Issue
3
Pages
576-584
ISSN
  • 0105-4538 (ISSN-L)
  • 1398-9995
OpenAlex
W2766150186
Cited by
65
References
31
Citations by year
2026: 1 · 2025: 1 · 2024: 8 · 2023: 3 · 2022: 7 · 2021: 18 · 2020: 5 · 2019: 13 · 2018: 7 · 2017: 1
FWCI
6.21
Type
journal article
Language
en
Open access
Locations
  • Allergy (publishedVersion, cc-by-nc-nd)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by-nc-nd)
  • Universitätsbibliothek der FU Berlin Hochschulschriftenstelle u. Dokumentenserver
Funders
Novartis Pharma
Topics
  • Health Sciences › Medicine › Rheumatology › Urticaria and Related Conditions
  • Life Sciences › Immunology and Microbiology › Immunology › Mast cells and histamine
  • Health Sciences › Medicine › Rheumatology › Eosinophilic Disorders and Syndromes
Keywords
omalizumab, chronic spontaneous urticaria, angioedema, quality of life, anti-IgE therapy, psychological well-being, Dermatology Life Quality Index
MeSH terms
Omalizumab, Adolescent, Adult, Aged, Angioedema, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life, Urticaria, Anti-Allergic Agents, Young Adult

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review