Evidence map›Paper›PMID 26340860›Full record

ArticleThe AAPS journal2016

Evaluation of IgE Antibodies to Omalizumab (Xolair®) and Their Potential Correlation to Anaphylaxis.

Dana L Baker, Gerald R Nakamura, Henry B Lowman, Saloumeh Kadkhodayan Fischer

Open access · bronzeAbstract read
In one paragraph

Article in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
0.8field-weighted citation impact, top 30% 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

10 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. 2021 Brazilian Thoracic Association recommendations for the management of severe asthma.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2021
    Review
  8. Article
  9. Anaphylaxis to three humanized antibodies for severe asthma: a case study.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2020
    Article
  10. The pathophysiology of anaphylaxis.The Journal of allergy and clinical immunology · 2017
    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

4 authors at 1 institution.

Dana L BakerDepartment of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
Gerald R NakamuraDepartment of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
Henry B LowmanDepartment of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
Saloumeh Kadkhodayan FischerDepartment of Assay Development and Technology, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA. fischer.sally@gene.com.
Genentech

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Omalizumab (Xolair®) is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab is used to treat IgE-mediated diseases such as chronic idiopathic urticaria (CIU) and moderate to severe allergic asthma. In pre-marketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3,507 (0.1%) patients. In post-marketing spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients based on an estimated exposure of about 57,300 patients from June 2003 through December 2006. To better understand the risk of anaphylaxis in patients with allergic asthma receiving omalizumab, a post-marketing pharmacosurveillance study was initiated in 2009. As part of this study, an assay was developed to detect antibodies of IgE isotype to omalizumab. Serum samples from patients in the study were evaluated using this assay. Our results indicated that there was no observable correlation between either anaphylaxis or skin test reactivity and the presence of antibodies of IgE isotype to omalizumab. Here, we discuss the development of this assay as well as the results of the immunogenicity assessment.

Indexed as

AdultAnaphylaxisAnti-Allergic AgentsAntibodiesAsthmaHumansImmunoglobulin EOmalizumabProduct Surveillance, PostmarketingSkin TestsAnti-Allergic AgentsAntibodiesImmunoglobulin EOmalizumabbiotin-mutant omalizumab-AAADIG-FcεR1-IgGIgE isotypeomalizumab/total IgE molar ratioomalizumab (Xolair®)

Identifiers

PMID26340860
PMCPMC4706281
OpenAlexW1207784773

What OpenQuestion holds

Textmetadata
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.