Evidence map›Paper›PMID 25046337›Full record

Trial reportThe Journal of investigative dermatology2015

Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study.

Sarbjit S Saini, Carsten Bindslev-Jensen, Marcus Maurer, Jean-Jacques Grob, Emel Bülbül Baskan, Mary S Bradley, Janice Canvin, Abdelkader Rahmaoui, Panayiotis Georgiou, Oral Alpan and 2 more

Erratum issuedOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of investigative dermatology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 119 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 10 pooled it
34.9field-weighted citation impact, top 1% 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

119 citing papers in PubMed, 10 syntheses or guidelines pooled it, 453 citations in OpenAlex.

  1. Pooled it
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  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. Guideline
  8. Pooled it
  9. Efficacy of Treatment of Non-hereditary Angioedema.Clinical reviews in allergy & immunology · 2018
    Pooled it
  10. Pooled it
  11. Trial
  12. Trial
  13. Fenebrutinib in HNature medicine · 2021
    Trial
  14. Trial
  15. Omalizumab substantially improves dermatology-related quality of life in patients with chronic spontaneous urticaria.Journal of the European Academy of Dermatology and Venereology : JEADV · 2017
    Trial
  16. Trial
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  18. Trial
  19. Review
  20. Article

59 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 6 countries.

Sarbjit S SainiJohns Hopkins Asthma and Allergy Center, Baltimore, Maryland, USA.
Carsten Bindslev-JensenDepartment of Dermatology and Allergy Centre, Odense University Hospital, Odense C, Denmark.
Marcus MaurerDepartment of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Jean-Jacques GrobDermatology Department, Timone Hospital and Aix-Marseille University, Marseille, France.
Emel Bülbül BaskanDermatology Department, Uludağ University Medical Faculty, Bursa, Turkey.
Mary S BradleyGenentech, Inc., South San Francisco, California, USA.
Janice CanvinNovartis Pharmaceuticals UK, Horsham, UK.
Abdelkader RahmaouiGenentech, Inc., South San Francisco, California, USA.
Panayiotis GeorgiouNovartis Pharmaceuticals UK, Horsham, UK.
Oral AlpanSection on Immunopathogenesis, O&O Alpan, Fairfax, Virginia, USA.
Sheldon SpectorCalifornia Allergy and Asthma Medical Group and the University of California Medical Center, Los Angeles, California, USA.
Karin RosénGenentech, Inc., South San Francisco, California, USA. Electronic address: rosen.karin@gene.com.
Novartis (United Kingdom) · GBAix-Marseille Université · FRBursa Uludağ Üni̇versi̇tesi̇ · TRCalifornia Allergy and Asthma Medical Group · USCharité - Universitätsmedizin Berlin · DEOdense University Hospital · DKO&O Alpan (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ASTERIA I was a 40-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous omalizumab as add-on therapy for 24 weeks in patients with chronic idiopathic urticaria/spontaneous urticaria (CIU/CSU) who remained symptomatic despite H1 antihistamine treatment at licensed doses. Patients aged 12-75 years with CIU/CSU who remained symptomatic despite treatment with approved doses of H1 antihistamines were randomized (1:1:1:1) in a double-blind manner to subcutaneous omalizumab 75 mg, 150 mg, or 300 mg or placebo every 4 weeks for 24 weeks followed by 16 weeks of follow-up. The primary end point was change from baseline in weekly itch severity score (ISS) at week 12. Among randomized patients (N=319: placebo n=80, omalizumab 75 mg n=78, 150 mg n=80, 300 mg n=81), 262 (82.1%) completed the study. Compared with placebo (n=80), mean weekly ISS was reduced from baseline to week 12 by an additional 2.96 points (95% confidence interval (CI): -4.71 to -1.21; P=0.0010), 2.95 points (95% CI: -4.72 to -1.18; P=0.0012), and 5.80 points (95% CI: -7.49 to -4.10; P<0.0001) in the omalizumab 75-mg (n=77), 150-mg (n=80), and 300-mg groups (n=81), respectively. The omalizumab 300-mg group met all nine secondary end points, including a significant decrease in the duration of time to reach minimally important difference response (⩾5-point decrease) in weekly ISS (P<0.0001) and higher percentages of patients with well-controlled symptoms (urticaria activity score over 7 days (UAS7) ⩽6: 51.9% vs. 11.3%; P<0.0001) and complete response (UAS7=0: 35.8% vs. 8.8%; P<0.0001) versus placebo. During the 24-week treatment period, 2 (2.9%), 3 (3.4%), 0, and 4 (5.0%) patients in the omalizumab 75-mg, 150-mg, 300-mg, and placebo groups, respectively, experienced a serious adverse event. Omalizumab 300 mg administered subcutaneously every 4 weeks reduced weekly ISS and other symptom scores versus placebo in CIU/CSU patients who remained symptomatic despite treatment with approved doses of H1 antihistamines.

Indexed as

AdolescentAdultAgedAged, 80 and overAnti-Allergic AgentsAntibodies, Anti-IdiotypicAntibodies, Monoclonal, HumanizedChildChronic DiseaseDouble-Blind MethodDrug ResistanceFemaleFollow-Up StudiesHistamine H1 AntagonistsHumansMaleAnti-Allergic AgentsAntibodies, Anti-IdiotypicAntibodies, Monoclonal, HumanizedHistamine H1 AntagonistsOmalizumabPlacebos

Identifiers

PMID25046337
PMCPMC4269803
OpenAlexW1968667225

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.