Format

Send to

Choose Destination
Med Devices (Auckl). 2016 Oct 12;9:361-369. eCollection 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.

Author information

1
Department of Dermatology, University of Utah School of Medicine, Salt Lake City, UT.
2
Arlington Dermatology, Arlington Heights, IL.
3
CWRU Schools of Medicine and Nursing, Case Western Reserve University Cleveland, OH.
4
Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
5
Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:

autoinjector; confidence; ease of use; ixekizumab; usability

Conflict of interest statement

KCD is an investigator for and received research grants from Amgen, Eli Lilly, Janssen, Stiefel, Abbvie, BMS, Celgene, Pfizer, Novartis, Xenoport and served as a consultant for Amgen, Eli Lilly, Janssen, Steifel, Abbvie, BMS, Celgene, Pfizer, Novartis, and Xenoport; JB has been a speaker and received honoraria from Janssen, Abbvie, Novartis, Celgene, Leo and was an investigator for and received research grants from Janssen, Abbvie, Novartis, Celgene, Leo, Boehringer Ingelheim, and Eli Lilly and was a consultant for and received honoraria for Eli Lilly. MAB and MB have no disclosures; DS, AG, CLS, BP, JRK, and FZ are employees at and stockholders of Eli Lilly. The authors report no other conflicts of interest in this work.

Supplemental Content

Full text links

Icon for Dove Medical Press Icon for PubMed Central
Loading ...
Support Center