Evidence map›Paper›PMID 31849500›Full record

ArticleJournal of asthma and allergy2019

Two-Year Integrated Efficacy And Safety Analysis Of Benralizumab In Severe Asthma.

J Mark FitzGerald, Eugene R Bleecker, Arnaud Bourdin, William W Busse, Gary T Ferguson, Laura Brooks, Peter Barker, Ubaldo J Martin

Open access · goldAbstract read
In one paragraph

Article in Journal of asthma and allergy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.6field-weighted citation impact, top 10% 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

22 citing papers in PubMed, 48 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Biologics in severe asthma: a state-of-the-art review.European respiratory review : an official journal of the European Respiratory Society · 2025
    Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Living without eosinophils: evidence from mouse and man.The European respiratory journal · 2023
    Review
  16. Review
  17. Observational
  18. Article
  19. Article
  20. 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

8 authors at 5 institutions in 3 countries.

J Mark FitzGeraldCentre for Heart and Lung Health, The Lung Centre Vancouver General Hospital, UBC Institute for Heart and Lung Health, Vancouver, BC, Canada.ORCID 0000-0002-8753-6056
Eugene R BleeckerDivisions of Pharmacogenomics and Genetics, Genomics and Precision Medicine, University of Arizona College of Medicine, Tucson, AZ, United States.ORCID 0000-0002-4767-3494
Arnaud BourdinDepartment of Respiratory Diseases, Hôpital Arnaud De Villeneuve, Montpellier, France.ORCID 0000-0002-4645-5209
William W BusseDepartment of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, United States.ORCID 0000-0003-2591-4696
Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, United States.
Laura BrooksAstraZeneca, Gaithersburg, MD, United States.
Peter BarkerAstraZeneca, Gaithersburg, MD, United States.
Ubaldo J MartinAstraZeneca, Gaithersburg, MD, United States.ORCID 0000-0002-0089-7677
AstraZeneca (United States) · USHôpital Arnaud de Villeneuve · FRUniversity of Arizona · USUniversity of Wisconsin–Madison · USVancouver General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBenralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody. Treatment with benralizumab significantly reduces exacerbations and improves lung function after 1 year for patients with severe, uncontrolled eosinophilic asthma.

objectiveWe explored whether benralizumab efficacy was sustained after an additional year of treatment while maintaining an acceptable safety profile.

methodsData from the pivotal 48-week SIROCCO and 56-week CALIMA studies were integrated with data from the predefined 56-week adult phase of the BORA extension study to provide a 2-year integrated efficacy and safety analysis of benralizumab. BORA enrolled patients who had completed SIROCCO or CALIMA. Patients receiving benralizumab 30 mg subcutaneously, either every 4 weeks (Q4W) or every 8 weeks (Q8W; first three doses Q4W), were assessed. Efficacy was evaluated based on baseline blood eosinophil counts from the pivotal studies (≥300 and <300 cells/μL).

resultsMean treatment exposures were 24.3 (Q4W, n=518) and 24.6 (Q8W, n=512) months. Exacerbation frequency reductions observed in SIROCCO/CALIMA were maintained; 50% of the patients had no exacerbations during the 2-year study period (crude exacerbation rate, Q8W: 0.56 exacerbations/year for patients with blood eosinophil counts ≥300 cells/μL). Lung function improvements with benralizumab were maintained for 2 years, as represented by increases in mean prebronchodilator forced expiratory volume in 1 second from baseline of 0.343 L and 0.364 L with 1 and 2 years of benralizumab Q8W treatment, respectively, for patients with blood eosinophil counts ≥300 cells/μL. Health-related quality of life improvements with benralizumab observed in the pivotal studies were also sustained. Adverse events and serious adverse event rates were similar between the BORA extension and SIROCCO/CALIMA periods, with no new or unexpected occurrence of adverse events.

conclusionThis benralizumab 2-year integrated analysis further supports long-term use of benralizumab for patients with severe, uncontrolled eosinophilic asthma.

Indexed as

asthmabenralizumabclinical featureseosinophilic inflammationinterleukin-5 receptorsafety

Identifiers

PMID31849500
PMCPMC6910092
OpenAlexW2991954549

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.