| Title |
Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience
|
|---|---|
| Published in |
Medical Devices : Evidence and Research, October 2016
|
| DOI | 10.2147/mder.s113752 |
| Pubmed ID | |
| Authors |
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 |
Most 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. The 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. In 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. The 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. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Practitioners (doctors, other healthcare professionals) | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 38 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 38 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 6 | 16% |
| Student > Ph. D. Student | 5 | 13% |
| Student > Bachelor | 4 | 11% |
| Student > Doctoral Student | 4 | 11% |
| Other | 3 | 8% |
| Other | 7 | 18% |
| Unknown | 9 | 24% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 10 | 26% |
| Pharmacology, Toxicology and Pharmaceutical Science | 5 | 13% |
| Engineering | 5 | 13% |
| Agricultural and Biological Sciences | 2 | 5% |
| Nursing and Health Professions | 2 | 5% |
| Other | 5 | 13% |
| Unknown | 9 | 24% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 13 October 2016.
All research outputs
#20,011,485
of 25,457,858 outputs
Outputs from Medical Devices : Evidence and Research
#227
of 314 outputs
Outputs of similar age
#244,531
of 332,783 outputs
Outputs of similar age from Medical Devices : Evidence and Research
#9
of 13 outputs
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