Evidence map›Paper›PMID 27785115›Full record

ArticleMedical devices (Auckland, N.Z.)2016

Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience.

Kristina Callis Duffin, Michael Bukhalo, Margaret A Bobonich, David Shrom, Fangyi Zhao, James R Kershner, Anne Gill, Beth Pangallo, Catherine L Shuler, Jerry Bagel

Abstract read
In one paragraph

Article in Medical devices (Auckland, N.Z.), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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

11 citing papers in PubMed.

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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

10 authors.

Kristina Callis DuffinDepartment of Dermatology, University of Utah School of Medicine, Salt Lake City, UT.
Michael BukhaloArlington Dermatology, Arlington Heights, IL.
Margaret A BobonichCWRU Schools of Medicine and Nursing, Case Western Reserve University Cleveland, OH.
David ShromLilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
Fangyi ZhaoLilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
James R KershnerLilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
Anne GillLilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
Beth PangalloLilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
Catherine L ShulerLilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
Jerry BagelPsoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost biologic therapies for psoriasis are delivered via subcutaneous injection. Ixekizumab, an anti-interleukin 17A monoclonal antibody approved for patients with moderate-to-severe plaque psoriasis, is delivered subcutaneously via prefilled syringe or autoinjector. Here we report the results of an ixekizumab autoinjector usability study as well as the patient-reported experience with the autoinjector in a clinical trial.

methodsThe usability study enrolled 49 subjects (patients with a range of autoimmune conditions or their caregivers). Subjects were randomized to a trained or untrained group and were evaluated for their ability to perform an injection successfully when provided the device and the instructions for use. In the clinical trial, 102 subjects (patients with psoriasis or their caregivers) used the autoinjector to deliver injections of ixekizumab (80 mg every 2 weeks after a starting dose of 160 mg). At weeks 0, 4, and 8, subjects completed the subcutaneous administration assessment questionnaire, which assesses the ease of use and confidence with using an injection device.

resultsIn the usability study, all subjects in the untrained arm performed successful injections, while two subjects in the trained arm had an injection failure. These incidences were not consistent with any pattern of issues with the device or the instructions for use. In the clinical trial, there were two injection failures of 674 total self-injections performed over 12 weeks. At the first use of the device, 95% of subjects either agreed or strongly agreed that the device was "overall easy to use", and they felt "confident the dose was complete" according to the subcutaneous administration assessment questionnaire.

conclusionThe ixekizumab autoinjector was used successfully by patients and caregivers with or without training. Subjects using the autoinjector in a clinical trial felt it was easy to use and felt confident while using it.

Indexed as

autoinjectorconfidenceease of useixekizumabusability

Identifiers

PMID27785115
PMCPMC5067052

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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.