Evidence map›Paper›PMID 34984792›Full record

Trial reportDermatologic therapy2022

Efficacy and safety of omalizumab in Chinese patients with anti-histamine refractory chronic spontaneous urticaria.

Weiru Yuan, Shuling Hu, Min Li, Lijia Yang, Lingling Liu, Min Zheng, Zaipei Guo, Zhiqiang Song, Chunlei Zhang, Qingchun Diao and 8 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Dermatologic therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 6 pooled it
5.8field-weighted citation impact, top 3% 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

21 citing papers in PubMed, 6 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. 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
  7. Trial
  8. Trial
  9. Article
  10. Review
  11. Article
  12. Spectrum and Impact of Reported Side Effects of Omalizumab in Patients With Chronic Urticaria: A Long-Term Multicentre Real-World Study.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2025
    Article
  13. Article
  14. Article
  15. Research hotspots in urticaria: A bibliometric study of the top 100 most cited articles.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
    Article
  16. Article
  17. Observational
  18. Article
  19. Article
  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

18 authors at 13 institutions in 4 countries.

Weiru YuanDepartment of Dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shuling HuChina Novartis Institutes for BioMedical Research Co., Ltd., Shanghai, China.
Min LiInstitute of Dermatology, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
Lijia YangWuxi No.2 People's Hospital, Wuxi, China.
Lingling LiuPeking University First Hospital, Beijing, China.
Min ZhengThe Second Affiliated hospital of Zhejiang University School of Medicine, Zhejiang, China.
Zaipei GuoWest China Hospital, Sichuan University, Chengdu, China.
Zhiqiang SongDepartment of Dermatology, The First Affiliated Hospital of Army Military Medical University, Chongqing, China.
Chunlei ZhangDepartment of Dermatology, Peking University Third Hospital, Beijing, China.
Qingchun DiaoChongqing Traditional Chinese Medicine Hospital, Chongqing, China.
Jinhua XuHuashan Hospital, Fudan University, Shanghai, China.
Alexia RichardNovartis Pharma AG, Basel, Switzerland.
Moreshwar PatwardhanNovartis Healthcare Pvt. Ltd., Hyderabad, India.
Tianmeng LyuNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Alkaz UddinNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Robert FogelNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Monica Ligueros-SaylanNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Jie ZhengDepartment of Dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0002-7961-6427
Novartis (United States) · USPeking University · CNShanghai Jiao Tong University · CNArmy Medical University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst People's Hospital of Chongqing · CNFudan University · CNNovartis (China) · CNNovartis (India) · INNovartis (Switzerland) · CHSecond Affiliated Hospital of Zhejiang University · CNSichuan University · CNWuxi No.2 People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Chronic spontaneous urticaria (CSU) is characterized by the spontaneous development of wheals, itching, and/or angioedema, for ≥6 weeks. In China, non-sedating H1-antihistamines (H1AH) are the recommended first-line treatment, with escalation up to 4× the standard dose in symptomatic patients to achieve control. Treatment options for Chinese patients who remain symptomatic on H1AH treatment are limited. This 20-week randomized, double blind, placebo-controlled, parallel-group study investigated the efficacy and safety of omalizumab as an add-on therapy for the treatment of patients with CSU who remained symptomatic despite H1AH treatment in China. Adult patients (N = 418) diagnosed with refractory CSU for ≥6 months were randomized (2:2:1) to receive omalizumab 300 mg (OMA300), omalizumab 150 mg (OMA150) or placebo, subcutaneously, every 4 weeks. Primary outcome was change from baseline to week 12 in weekly itch severity score (ISS7). Safety was assessed by rates of adverse events (AEs). Demographic and disease characteristics at baseline were comparable across treatment groups. At week 12, statistically significant greater decreases from baseline were observed in ISS7 with OMA300 (least square mean difference [LSM]: -4.23; 95% confidence interval [CI]: -5.70, -2.77; p < 0.001) and OMA150 (LSM: -3.79; 95% CI: -5.24, -2.33; p < 0.001) versus placebo. Incidence of treatment-emergent AEs over 20 weeks was slightly higher with OMA300 (71.3%) compared to OMA150 and placebo groups (64.7% and 63.9%, respectively). The incidences of serious AEs were balanced between groups. This study demonstrated the efficacy and safety of omalizumab in Chinese adult patients with CSU who remained symptomatic despite H1AH therapy.

Indexed as

Anti-Allergic AgentsChronic UrticariaUrticariaAdultChronic DiseaseHistamine H1 AntagonistsHumansOmalizumabTreatment OutcomeAnti-Allergic AgentsHistamine H1 AntagonistsOmalizumabChinesechronic spontaneous urticariaefficacyomalizumabsafety

Identifiers

PMID34984792
PMCPMC9286033
OpenAlexW4206399603

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.