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

Figures & data

Figure 1 Ixekizumab autoinjector.

Figure 2 Summary of research informing the design and validation of the autoinjector.

Abbreviations: AS, ankylosing spondylitis; Ps, psoriasis; PsA, psoriatic arthritis; RA, rheumatoid arthritis; SLE, systemic lupus erythematosus.

Table 1 Summary of autoinjector features

Design principle	Features
Easy to use The device should be easy to manipulate, with different ways of holding or interacting with it for patients with a range of physical abilities	• Large dose button • Wide body diameter with textured surface • Large base cap • Triangular base keeps device stable vertically or horizontally during storage
Easy to understand The device operation should be intuitive with minimal steps	• Wide flared base allows device to be held stably at the point of injection and eliminates the need for pinching up the skin or to use a specific injection angle
Easy dose confirmation Patients should feel confident that they are using the device appropriately with confirmation that they are successfully delivering their dose	• Clear base allows visualization of the injection site and drug solution • Audible clicks at the beginning and end of the injection provide auditory confirmation of dose delivery
Safe to use The device can be safely used and disposed of	• Easy-to-move lock prevents misfiring of the device • A needle that retracts after the injection is complete

Table 2 Tasks performed for injection

Get ready	1. Let autoinjector come to room temperature for
	30 minutes after taking out of refrigerator
	2. Inspect the autoinjector to ensure:
	a. solution does not look cloudy or discolored orcontain small specks
	b. it is not damaged or past expiration date
	3. Choose injection site (thigh, abdomen, back of arm)
Inject	4. Make sure lock is in lock position
	5. Twist off cap
	6. Place clear base flat against skin
	7. Unlock device
	8. Press injection button and hold for 10 seconds
Finish	9. Dispose

Table 3 SQAAQ questionnaire

1	Easy for me to learn how to use
2	Easy for me to unlock
3	Easy to hold in my hand when I inject dose
4	Easy to inject my dose
5	Easy to know that my dose is complete
6	Easy to store device in refrigerator
7	Easy to remove needle shield/cover
8	Easy to pick up
9	Overall easy to use
10	Device is stable against skin during injection
11	Confident in ability to use the device
12	I am confident my dose is complete
Response options: (1) Strongly disagree; (2) Disagree; (3) Slightly disagree; (4) Neither agree nor disagree; (5) Slightly agree; (6) Agree; (7) Strongly agree

Abbreviation: SQAAQ, subcutaneous administration assessment questionnaire.

Table 4 Usability study: summary of injection failures in patients and caregivers by training arm

Training group	User group	Injection failures
Trained (n=17)	Patients (n=14)	2
	Caregivers (n=3)	0
Untrained (n=32)	Patients (n=29)	0
	Caregivers (n=3)	0

Figure 3 Patient responses to the SQAAQ weeks 0–4 and 8 (observed case data).

Notes: The proportion of patients that agreed or strongly agreed to each item of the SQAAQ is shown. Missing data were not imputed.
Abbreviation: SQAAQ, subcutaneous administration assessment questionnaire.

Figure S1 Patient responses to the SQAAQ weeks 0–4 and 8 (observed case data) – prefilled syringe group.

Notes: The proportion of patients that agreed or strongly agreed to each item of the SQAAQ is shown. Missing data were not imputed.

Abbreviation: SQAAQ, subcutaneous administration assessment questionnaire.

Video S1 Ixekizumab autoinjector.