Evidence map›Paper›PMID 37360967›Full record

ArticleJournal of asthma and allergy2023

Real-World Safety and Effectiveness of Omalizumab in Moderate to Severe Allergic Asthma Patients in China: A Post-Authorization Study.

Nan Su, Lili Zhi, Fengxia Liu, Yongsheng Wang, Qingling Zhang, Xiansheng Liu, Xueyan Wang, Guodong Hao, Xiuqin Zhang, Qiang Hu and 7 more

Open access · goldAbstract read
In one paragraph

Article in Journal of asthma and allergy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 8% 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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Safety of biologics for the treatment of asthma in children and adolescents: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025
    Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Asthma Phenotypes in the Era of Personalized Medicine.Journal of clinical medicine · 2023
    Review
  13. 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

17 authors at 12 institutions in 2 countries.

Nan SuDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, Beijing, People's Republic of China.
Lili ZhiDepartment of Allergy, Shandong Provincial Qianfoshan Hospital, The First Affiliated Hospital of Shandong First Medical University, Shandong Institute of Respiratory Diseases, Jinan, People's Republic of China.
Fengxia LiuDepartment of Allergy, Weifang People's Hospital, Weifang, Shandong, People's Republic of China.
Yongsheng WangDepartment of Pulmonary and Critical Care Medicine, Chengdu First People's Hospital, Chengdu, People's Republic of China.
Qingling ZhangDepartment of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, State Key Laboratory of Respiratory Diseases, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.
Xiansheng LiuDepartment of Pulmonary and Critical Care Medicine, Shanxi Bethune Hospital, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, Shanxi Province, People's Republic of China.ORCID 0000-0002-9598-5054
Xueyan WangAllergy Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, People's Republic of China.
Guodong HaoDepartment of Allergy, Tangshan Gongren Hospital, Tangshan, Hebei, People's Republic of China.
Xiuqin ZhangDepartment of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu, People's Republic of China.
Qiang HuDepartment of Pulmonary and Critical Care Medicine, Panzhihua Integrated Chinese and Western Medicine Hospital, Panzhihua, Sichuan, People's Republic of China.ORCID 0009-0008-6980-7407
Monica Ligueros-SaylanRespiratory Clinical/Medical 2, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Alkaz UddinAnalytics - Global Health DU, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Jing YangNeuroscience & Respiratory Development Unit, Beijing Novartis Pharma. Co. Ltd, Beijing, People's Republic of China.
Tiantian LiangRespiratory Clinical Development, China Novartis Institutes for BioMedical Research Co., Ltd, Beijing, People's Republic of China.
Liju DingGCTM-Group-2, China Novartis Institutes for BioMedical Research Co., Ltd, Shanghai, People's Republic of China.
Runqin LiNew Products, Beijing Novartis Pharma. Co. Ltd, Shanghai, People's Republic of China.
Chen WangDepartment of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China- Japan Friendship Hospital, Beijing, People's Republic of China.
Novartis (China) · CNCapital Medical University · CNChina-Japan Friendship Hospital · CNFirst Affiliated Hospital of Chengdu Medical College · CNFirst Affiliated Hospital of Guangzhou Medical University · CNPanzhihua Central Hospital · CNShandong Provincial QianFoShan Hospital · CNShanxi Medical University · CNSoochow University · CNTangshan Gongren Hospital · CNTris Pharma (United States) · USWeifang People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Omalizumab was first approved in China in 2017 for the treatment of moderate to severe allergic asthma for adult and adolescent patients aged ≥12 years. In accordance with the Chinese Health Authority requirement, the post-authorization safety study (PASS) was conducted to evaluate the safety and effectiveness of omalizumab in a real-world setting in patients with moderate to severe allergic asthma in China over a 24-week observation period. Patients and Methods: This is a single-arm, non-interventional, multicenter, PASS conducted in adult, adolescent, and pediatric patients (≥6 years old) with moderate to severe allergic asthma receiving omalizumab in a real-world clinical setting from 2020 to 2021 in 59 sites of mainland China. Results: In total, 1546 patients were screened and 1528 were enrolled. They were stratified according to age (6 to <12 years [n = 191]; ≥12 years [n = 1336]; unknown [n = 1]). Among the overall population, 23.6% and 4.5% of patients reported adverse events (AEs) and serious adverse events (SAEs), respectively. Among pediatric patients (6 to <12 years), 14.1% and 1.6% patients reported AEs and SAEs, respectively. AEs that led to treatment discontinuation in both age groups were <2%. No new safety signals were reported. Effectiveness results showed improvement in lung function, asthma control, and quality of life (QoL). Conclusion: The findings of the current study demonstrated that the safety profile of omalizumab was consistent with its known profile in allergic asthma, and no new safety signals were reported. Omalizumab treatment was effective in improving the lung function and QoL in patients with allergic asthma.

Indexed as

adverse drug eventsallergic asthmaeffectivenessomalizumabsafety

Identifiers

PMID37360967
PMCPMC10289103
OpenAlexW4381250192

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.