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.
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.
  
  
  CONCLUSIONS
  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.
authors: Department of Dermatology, University of Utah School of Medicine, Salt Lake City, UT.
authors: Kristina
authors: K
authors: Callis Duffin
authors: Arlington Dermatology, Arlington Heights, IL.
authors: Michael
authors: M
authors: Bukhalo
authors: CWRU Schools of Medicine and Nursing, Case Western Reserve University Cleveland, OH.
authors: Margaret A
authors: MA
authors: Bobonich
authors: Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: David
authors: D
authors: Shrom
authors: Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: Fangyi
authors: F
authors: Zhao
authors: Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: James R
authors: JR
authors: Kershner
authors: Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: Anne
authors: A
authors: Gill
authors: Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: Beth
authors: B
authors: Pangallo
authors: Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.
authors: Catherine L
authors: CL
authors: Shuler
authors: Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.
authors: Jerry
authors: J
authors: Bagel
keywords: autoinjector; confidence; ease of use; ixekizumab; usability