Evidence map›Paper›PMID 31695439›Full record

ArticleJournal of asthma and allergy2019

Single-Use Autoinjector Functionality And Reliability For At-Home Administration Of Benralizumab For Patients With Severe Asthma: GRECO Trial Results.

Gary T Ferguson, Jeremy Cole, Magnus Aurivillius, Paul Roussel, Peter Barker, Ubaldo J Martin, GRECO study investigators

Registry-linked trialOpen 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 trial NCT02918071 (A Multicenter, Open-Label, Functionality, Reliability and Performance Study of a Single-Use Auto-Injector With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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.

NCT02918071 phase3completednot on this map

A Multicenter, Open-Label, Functionality, Reliability and Performance Study of a Single-Use Auto-Injector With Home-administered Subcutaneous Benralizumab in Adult Patients With Severe Asthma (GRECO)

TypeinterventionalSponsorAstraZenecaRan2016 to 2017Enrolled121ConditionsAsthmaArmsBenralizumab
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

7 authors at 2 institutions in 2 countries.

Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Jeremy ColeOK Clinical Research, LLC, Edmond, OK, USA.
Magnus AurivilliusAstraZeneca, Mölndal, Sweden.
Paul RousselAstraZeneca, Gaithersburg, MD, USA.
Peter BarkerAstraZeneca, Gaithersburg, MD, USA.
Ubaldo J MartinAstraZeneca, Gaithersburg, MD, USA.ORCID 0000-0002-0089-7677
GRECO study investigators
AstraZeneca (United States) · USAstraZeneca (Sweden) · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAccessorized prefilled syringes (APFS) have demonstrated functionality and reliability for subcutaneous (SC) delivery, including self-administration, of benralizumab 30 mg in the clinic or at home. The multicenter, open-label GRECO study (NCT02918071) assessed functionality and reliability of a single-use autoinjector (AI) for at-home benralizumab administration by patients or their caregivers. PATIENTS AND

methodsAdults with severe asthma received benralizumab SC injections at the study site at Weeks 0, 4, and 8. The first dose was administered by health care providers. Patients/caregivers had the option of administering the second dose and were required to administer the third dose under supervision. At Weeks 12 and 16, patients/caregivers administered benralizumab via AI at home. After each administration, patients/caregivers completed questionnaires concerning administration and device functioning. All AI devices used were returned for evaluation.

resultsA total of 595 AIs were used for 121 patients (mean age 48.5 years; 64% female) in the clinic and at home. Of 116 participants, 113 (97.4%; 95% confidence interval [CI]: 92.63-99.46) and 112 (96.6%; 95% CI: 91.41-99.05) successfully administered benralizumab at home at Weeks 12 and 16, respectively; 108 (93.1%; 95% CI: 86.86-96.98) were successful on both occasions. Throughout the study, 10 (1.7%) AI administrations were unsuccessful: 8 (1.3%) because of user error, 1 (0.2%) with undetermined cause, and 1 (0.2%) because of a manufacturing defect. Benralizumab efficacy (assessed by Asthma Control Questionnaire 6 score) and pharmacokinetics for patients using the AI were comparable to published results for patients receiving benralizumab via syringe in a clinical setting. No new or unexpected safety findings were observed.

conclusionAIs were functional, reliable, and performed well in the clinic and at home. Nearly all patients and caregivers successfully administered SC benralizumab via AI. Benralizumab availability in AI and APFS could provide patients with choices for self-administration.

Indexed as

Autoinjectorbenralizumabbiologicclinical trialdelivery systemeosinophilprefilled syringesubcutaneous

Identifiers

PMID31695439
PMCPMC6815754
OpenAlexW2982067491

What OpenQuestion holds

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LicenceCC BY-NC
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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.