Evidence map›Paper›PMID 30774388›Full record

ArticleJournal of asthma and allergy2019

Daily patient-reported health status assessment improvements with benralizumab for patients with severe, uncontrolled eosinophilic asthma.

Sean O'Quinn, Xiao Xu, Ian Hirsch

2 registry-linked trialsOpen 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. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% 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.

NCT01914757 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Asthmatic Adults and Adolescents Inadequately Controlled on Inhaled Corticosteroid Plus Long-acting β2 Agonist (CALIMA)

TypeinterventionalSponsorAstraZenecaRan2013 to 2016Enrolled2,508ConditionsAsthmaArmsBenralizumab, Placebo
NCT01928771 phase3completednot on this map

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

TypeinterventionalSponsorAstraZenecaRan2013 to 2016Enrolled2,681ConditionsAsthmaArmsBenralizumab, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Anti-IL-5 therapies for asthma.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Article
  4. Review
  5. Article
  6. Article
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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

3 authors at 1 institution in 1 country.

Sean O'QuinnAstraZeneca, Gaithersburg, MD, USA, Sean.OQuinn@astrazeneca.com.
Xiao XuAstraZeneca, Gaithersburg, MD, USA, Sean.OQuinn@astrazeneca.com.
Ian HirschAstraZeneca, Gaithersburg, MD, USA, Sean.OQuinn@astrazeneca.com.
AstraZeneca (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with severe, uncontrolled asthma experience debilitating symptoms that result in meaningful reductions to health-related quality of life. Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody that reduces exacerbations and improves asthma symptoms for patients with severe, uncontrolled eosinophilic asthma.

objectiveThe objective of this study was to evaluate improvements in daily asthma-related health status outcomes following treatment with benralizumab.

methodsPooled results from the SIROCCO (NCT01928771) and CALIMA (NCT01914757) Phase III studies were analyzed. Patients aged 12-75 years with severe, uncontrolled asthma, and blood eosinophil counts (BEC) ≥300 and ≥150 cells/µL were evaluated. Patients received subcutaneous benralizumab 30 mg every 4 weeks (Q4W) or every 8 weeks (Q8W, first three doses Q4W) or placebo and completed a daily diary reporting rescue medication use, night-time awakening requiring rescue medication use, perceived tiredness, and asthma-related activity impairment. Outcome measures were compared across treatment arms from baseline to end of treatment (EOT) using a mixed-effect model for repeated measures analyses.

resultsPatients with BEC ≥300 cells/µL receiving benralizumab Q8W had greater improvements in all patient-reported outcomes at EOT relative to baseline than patients receiving placebo (all nominal

conclusionBenralizumab produces sustained reductions by as early as 3 days in rescue medication use and activity impairment for patients with severe, uncontrolled eosinophilic asthma.

Indexed as

asthmabenralizumabeosinophilsinterleukin-5 receptormonoclonal antibodypatient-reported outcomes

Identifiers

PMID30774388
PMCPMC6350639
OpenAlexW2911635896

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.