Evidence map›Paper›PMID 30271122›Full record

ArticlePatient preference and adherence2018

Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies.

Virginia L Stauffer, Ryan Sides, Michel Lanteri-Minet, William Kielbasa, Yan Jin, Katherine J Selzler, Stewart J Tepper

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Patient preference and adherence, 2018. 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 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing 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.

NCT02614287 phase3completednot on this map

A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2018Enrolled270ConditionsMigraineArmsGalcanezumab
NCT02836613 phase1completednot on this map

Pharmacokinetics and Pharmacodynamics of LY2951742 (Galcanezumab) in Healthy Subjects Following Subcutaneous Administration of LY2951742 (Galcanezumab) Solution in a Prefilled Syringe or an Autoinjector

TypeinterventionalSponsorEli Lilly and CompanyRan2016 to 2017Enrolled160ConditionsHealthyArmsGalcanezumab
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 40 citations in OpenAlex.

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  9. Clinical Qualification of Subcutaneous Injection Devices for Monoclonal Antibodies.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
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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 3 institutions in 2 countries.

Virginia L StaufferLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com.
Ryan SidesLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com.
Michel Lanteri-MinetPain Department, CHU Nice, Nice, France.
William KielbasaLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com.
Yan JinLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com.
Katherine J SelzlerLilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA, stauffer_virginia@lilly.com.
Stewart J TepperGeisel School of Medicine at Dartmouth, Hanover, NH, USA.
Eli Lilly (United States) · USCentre Hospitalier Universitaire de Nice · FRDartmouth College · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe aim of this study was to compare the usability and patient-rated experiences of an autoinjector with a prefilled syringe in patients with migraine, who self-administered galcanezumab, and to compare pharmacokinetic parameters between these devices. MATERIALS AND

methodsPatient-rated experiences with an investigational autoinjector and a prefilled syringe were compared in an open-label, 12-month study of once-monthly injections of galcanezumab 120 or 240 mg (NCT02614287). Patient-rated ease of usability was assessed with the Subcutaneous Administration Assessment Questionnaire (SQAAQ) and compared between devices. Positive responses on the SQAAQ were rated as "agree or strongly agree" to 12 statements. Tolerability was assessed by the frequency of injection-site-related adverse events (AEs) by device and injection location. In a separate study, galcanezumab pharmacokinetics in healthy subjects was compared between the devices (NCT02836613).

resultsIn the open-label clinical trial, 179 patients used both the prefilled syringe and autoinjector at least once. The majority of patients (91%-97%) had positive responses on the SQAAQ to the use of autoinjector across the items assessed. There were 23 injection-site-related AEs with the first self-administered injection with the prefilled syringe (N=7) or autoinjector (N=16;

conclusionThe ease of usability with either device was comparable, and there were no significant differences in tolerability between the prefilled syringe and autoinjector with the first self-administration; however, the analysis was not powered to detect a clinically significant difference. Galcanezumab pharmacokinetics were comparable between devices.

Indexed as

devicesgalcanezumabpharmacokineticsself-administered injectionsSQAAQ

Identifiers

PMID30271122
PMCPMC6147689
OpenAlexW2892069777

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.