Evidence map›Paper›PMID 28859263›Full record

Trial reportAllergy2018

Response to omalizumab using patient enrichment criteria from trials of novel biologics in asthma.

T B Casale, B E Chipps, K Rosén, B Trzaskoma, T Haselkorn, T A Omachi, S Greenberg, N A Hanania

Open access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Allergy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 2 pooled it
11.7field-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

54 citing papers in PubMed, 2 syntheses or guidelines pooled it, 155 citations in OpenAlex.

  1. 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
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Biologics in severe asthma: a state-of-the-art review.European respiratory review : an official journal of the European Respiratory Society · 2025
    Review
  8. Article
  9. The Incredible Adventure of Omalizumab.International journal of molecular sciences · 2024
    Review
  10. Article
  11. Review
  12. Observational
  13. Article
  14. Article
  15. Clinical implications of asthma endotypes and phenotypes.Allergy and asthma proceedings · 2022
    Article
  16. Review
  17. The new era of add-on asthma treatments: where do we stand?Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022
    Review
  18. Current unmet needs and potential solutions to uncontrolled asthma.European respiratory review : an official journal of the European Respiratory Society · 2022
    Review
  19. Review
  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

8 authors at 5 institutions in 1 country.

T B CasaleDivision of Allergy and Immunology, University of South Florida, Tampa, FL, USA.ORCID 0000-0002-3149-7377
B E ChippsCapital Allergy & Respiratory Disease Center, Sacramento, CA, USA.
K RosénGenentech, Inc., South San Francisco, CA, USA.
B TrzaskomaGenentech, Inc., South San Francisco, CA, USA.
T HaselkornEpiMetrix, Inc., Los Altos, CA, USA.
T A OmachiGenentech, Inc., South San Francisco, CA, USA.
S GreenbergNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
N A HananiaSection of Pulmonary and Critical Care Medicine, Asthma Clinical Research Center, Baylor College of Medicine, Houston, TX, USA.
Baylor College of Medicine · USCapital Allergy and Respiratory Disease Center · USNovartis (United States) · USSentimetrix (United States) · USUniversity of South Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecent efficacy studies of asthma biologics have included highly enriched patient populations. Using a similar approach, we examined factors that predict response to omalizumab to facilitate selection of patients most likely to derive the greatest clinical benefit from therapy.

methodsData from two phase III clinical trials of omalizumab in patients with allergic asthma were examined. Differences in rates of asthma exacerbations between omalizumab and placebo groups during the 16-week inhaled corticosteroid (ICS) dose-stable phase were evaluated with respect to baseline blood eosinophil counts (eosinophils <300/μL [low] vs ≥300/μL [high]) and baseline markers of asthma severity (emergency asthma treatment in prior year, asthma hospitalization in prior year, forced expiratory volume in 1 second [FEV

resultsAdults/adolescents (N = 1071) were randomized to receive either omalizumab (n = 542) or placebo (n = 529). In the 16-week ICS dose-stable phase, rates of exacerbations requiring ≥3 days of systemic corticosteroid treatment were 0.066 and 0.147 with omalizumab and placebo, respectively, representing a relative rate reduction in omalizumab-treated patients of 55% (95% CI, 32%-70%; P = .002). For patients with eosinophils ≥300/μL or with more severe asthma, this rate reduction was significantly more pronounced.

conclusionIn patients with allergic asthma, baseline blood eosinophil levels and/or clinical markers of asthma severity predict response to omalizumab.

Indexed as

AdolescentAdultAnti-Asthmatic AgentsAsthmaBiological ProductsDouble-Blind MethodFemaleHumansMaleOmalizumabPatient SelectionSeverity of Illness IndexTreatment OutcomeYoung AdultAnti-Asthmatic AgentsBiological ProductsOmalizumabasthmabiologic therapybiomarkerseosinophilsomalizumab

Identifiers

PMID28859263
PMCPMC5813202
OpenAlexW2750584686

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.