Nurse and Patient Perceptions and Preferences for Subcutaneous Autoinjectors for Inflammatory Joint or Bowel Disease: Findings from a European Survey

Nurses and patients were recruited to participate in both studies by local recruitment agencies based in the UK and Germany. Recruitment was via panel databases (lists of people who have previously opted in to be contacted for market research purposes; membership was reliant on relevant privacy permission), which was supplemented by recruitment through patient associations and support groups.

Only nurses with sufficient experience with autoinjector devices were eligible to participate in the studies. Specifically, nurses were screened to ensure they were a practice nurse/nurse practitioner, rheumatology specialist nurse, or gastroenterology specialist nurse in the UK or Germany with ≥ 1 year of experience and > 75% of their time dedicated to direct patient care. In addition, nurses needed to have experience in patient education and training with regard to using biologic therapy that involves self-injection, familiarity with how the Humira autoinjector is used, and experience managing ≥ 10 patients with inflammatory joint disease, Crohn’s disease, or ulcerative colitis who self-administer a biologic each month, including ≥ 3 patients who use the Humira autoinjector (although nurses did not have to personally train those patients).

Patients were screened to ensure they were aged 18–65 years and had a diagnosis of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, or Crohn’s disease. Patients were required to have been injecting Humira themselves via an autoinjector device for ≥ 3 months at the time of screening. However, prior experience with the Imraldi or MyClic autoinjectors was not required for study enrollment.

Two surveys were run as face-to-face interviews using training devices with neither needles nor active ingredients. Before initiating the study, participants were informed that they were participating in a market research study sponsored by a pharmaceutical company and designed to understand perceptions of medical devices and reactions to a potential new autoinjector. A moderator was present throughout each interview. The 20-min computer-based questionnaire evaluating the Imraldi versus Humira autoinjectors was completed first, followed by a 10- to 15-min break. The same nurse and patient participants then completed the 20-min computer-based questionnaire evaluating the Imraldi versus Enbrel MyClic autoinjectors.

The nurse and patient questionnaires, which include show cards with illustrations of each autoinjector, are available in the Electronic Supplementary Material (ESM) Appendix (additional illustrations and information on each autoinjector can be found in their respective European public assessment report [EPAR] product information documents [7, 8, 25]). The questionnaires were divided into four sections. In the first section, all participants were asked about their prior experience with and awareness of various autoinjector devices; in addition, nurses were asked to rate the importance of autoinjector design in treatment selection and medication adherence for patients with inflammatory joint or bowel diseases. In the second section, the moderator provided participants with show cards illustrating how to use each autoinjector before allowing them to handle training versions of each one. The order in which the two autoinjectors were introduced was randomized for each participant interview. In the third section of each questionnaire, participants indicated which of the two autoinjectors they preferred and wrote their reasons for that preference. Participants were then asked for their preference of autoinjector based on specific attributes, including: (1) ease of use, (2) ease of assessing solution clarity, (3) indication that a full dose was administered, (4) audio signals, (5) ease of grip, and (6) perceived ease of administering a dose. In addition, nurses were asked which autoinjector they would recommend to others and which would be easier to teach patients how to use, and patients were asked which autoinjector they would prefer to use to continue treatment. The majority of questions in this section of the questionnaire had previously been validated in a study of patients with rheumatoid arthritis, nurses, and rheumatologists [20]. The final section of the questionnaire included questions on participant demographics, including gender and age.

A total of 101 nurses (50 from the UK and 51 from Germany) participated in both studies (Table 1). Rheumatology specialist nurses and gastroenterology specialist nurses each constituted half of all nurse participants. All nurses had prior familiarity with the Humira autoinjector (100%) and/or the Enbrel MyClic autoinjector (65%), and the majority of nurses trained/supported patients self-administering using the Humira autoinjector (96%) or the Enbrel MyClic autoinjector (52%). On a 7-point scale (1 = not at all important; 4 = neither important nor unimportant; 7 = extremely important), nurses rated a mean score of 6.27 for the importance of the autoinjector design when selecting a treatment for inflammatory joint or bowel disease. Similarly, nurses rated a mean score of 6.54 on a 7-point scale (1 = no impact at all; 7 = great positive impact) for the importance of patients being comfortable with using a device in increasing adherence during the treatment of inflammatory joint or bowel disease.

Additionally, a total of 151 patients (90 from the UK and 61 from Germany) participated in both studies (Table 2). Patients had a variety of inflammatory conditions, including rheumatoid arthritis (37%), ulcerative colitis (23%), Crohn’s disease (30%), psoriatic arthritis (15%), and axial spondyloarthritis (3%). Of the enrolled patients, 54% were female, 61% were aged > 40 years, and 95 and 18% were previously aware of the Humira and Enbrel MyClic autoinjectors, respectively, with 92% using the Humira autoinjector and 3% using the Enbrel MyClic autoinjector at the time of the study.

In the first study, 85% of nurses and 78% of patients preferred the Imraldi autoinjector over the Humira autoinjector (Fig. 1). When the data were analyzed according to geographic region, the Imraldi autoinjector was preferred by 90% of nurses and 84% of patients in the UK and 80% of nurses and 69% of patients in Germany (ESM Tables S1 and S2). The main reasons for preferring the Imraldi autoinjector over the Humira autoinjector were: convenient and easy to use/inject/handle (60% of nurses and 63% of patients), fits well and does not slip in hand (43 and 40%, respectively), has an initiation mechanism that requires no thumb trigger button (41 and 30%, respectively), has a large and visual control that is suitable for hearing-impaired patients (42 and 27%, respectively), has a double click that is suitable for visually impaired patients (49 and 38%, respectively), and requires removal of only one cap (34 and 33%, respectively; ESM Tables S3 and S4). Most nurses and patients indicated that the Imraldi autoinjector outperformed the Humira autoinjector with regard to ease of use, ease of grip, ease of dose administration, and feedback after administering a full dose (Fig. 2). These results remained consistent when participants from the UK and Germany were analyzed separately (ESM Tables S1 and S2). Consequently, 83% of all nurses (UK 94%; Germany 73%) thought it would be easier to teach patients how to use the Imraldi autoinjector than how to use the Humira autoinjector, and 87% of all nurses (UK 92%; Germany 82%) would recommend the Imraldi autoinjector over the Humira autoinjector (Fig. 1a; ESM Table S1). Furthermore, 79% of all patients (UK 86%; Germany 70%) would select the Imraldi autoinjector over the Humira autoinjector to continue treatment (Fig. 1b; ESM Table S2). Patient study results remained consistent regardless of age or diagnosed inflammatory condition, and nurse study results remained consistent regardless of specialty (ESM Tables S1 and S2).

In the second study, 86% of nurses and 79% of patients preferred the Imraldi autoinjector over the Enbrel MyClic autoinjector (Fig. 3). When the data were analyzed according to geographic region, the Imraldi autoinjector was preferred by 88% of nurses and 84% of patients in the UK and 84% of nurses and 70% of patients in Germany (ESM Tables S5 and S6). The top reasons indicated for the preference of the Imraldi autoinjector over the Enbrel MyClic autoinjector were: convenient and easy to use/inject/handle (45% of nurses and 65% of patients), fits well and does not slip in hand (57 and 51%, respectively), and has an automatic start that requires no thumb trigger button (45 and 27%, respectively; ESM Tables S7 and S8). Nurses and patients strongly preferred the Imraldi autoinjector over the Enbrel MyClic autoinjector for its ease of use, ease of grip, and ease of dose administration (Fig. 4). These results remained consistent for both the UK and German cohorts when evaluated separately by geographic region (ESM Tables S5 and S6). Nurses and patients also preferred the Imraldi autoinjector over the Enbrel MyClic autoinjector when evaluating ease of assessing clarity of the injection solution, feedback after administering a full dose, and audio signals; compared with other questions, a higher percentage of participants chose ‘no preference’ for these questions, although the percentage of participants who preferred the Enbrel MyClic autoinjector remained low (5–15%). Overall, 82% of all nurses (UK 86%; Germany 78%) thought it would be easier to teach patients how to use the Imraldi autoinjector than how to use the Enbrel MyClic autoinjector, and 85% of all nurses (UK 86%; Germany 84%) would recommend the Imraldi autoinjector over the Enbrel MyClic autoinjector (Fig. 3a; ESM Table S5). Moreover, 81% of all patients (UK 88%; Germany 72%) indicated that they would select the Imraldi autoinjector over the Enbrel MyClic autoinjector to continue treatment (Fig. 3b; ESM Table S6). Patient study results remained consistent across age groups and diagnosed inflammatory conditions. Nurse study results stayed consistent irrespective of specialization or prior familiarity with the Enbrel MyClic autoinjector (ESM Tables S5 and S6).

Of note, the design of the study had some limitations. Participants’ prior experience with the Humira and Enbrel MyClic autoinjectors may have negatively or positively biased their responses due to their familiarity with the devices (e.g., some participants may feel more comfortable with a known device, while others may be drawn to something new). Furthermore, the same nurses and patients participated in both studies; the questionnaire for evaluation of the Imraldi versus Humira autoinjectors always took place first, with the questionnaire for evaluation of the Imraldi versus Enbrel MyClic autoinjectors initiated after a 10- to 15-min break. At the time of the comparison against the Enbrel MyClic autoinjector, participants had prior training with Imraldi due to their participation in the first study and will have also realized that the Imraldi autoinjector was a focus of both studies. The study order may therefore have biased the Imraldi versus Enbrel MyClic autoinjector study results.