OBJECTIVES

To describe the value and operational learnings of embedded interviews using mepolizumab trials as a case study. Mepolizumab is licensed to treat severe eosinophilic asthma in the US. Development of a prefilled autoinjector (AI) and prefilled syringe (PFS) has been undertaken to allow self-administration, which may improve the patient treatment experience.

METHODS

Quantitative questionnaires [AI: n=153; PFS: n=56] and complementary qualitative exit interviews [AI: n=25; PFS: n=7] assessing the patient experience of self-injection were embedded in two real-world use studies of mepolizumab administered via an AI [N=159] and PFS [N=56].

RESULTS

• Capturing the patient experience through clinical endpoints alongside quantitative and qualitative patient reported outcomes provided a fuller picture of the value of the mepolizumab AI and PFS.
• Qualitative interviews allowed improved interpretation of quantitative results.

Example – mepolizumab AI/PFS self-administration studies

Primary endpoint

• > 99% of injections via both devices were successfully self-administered at week 8.

Example of patient treatment experience results

• Quantitative (satisfaction): >96% of respondents were “satisfied”/“very satisfied” with using the device (AI/PFS) at home.
  • AI qualitative response example:

“… it’s comfortable. I have it at home, I’m independent from anyone else. I can do it any day of the week, any time of the day, and, you know, it’s easy to do. It’s not a big deal”.

• Quantitative (convenience): >96% of respondents reported receiving mepolizumab using the device at home (AI/PFS) as “moderately”/”very”/”extremely” convenient.
  • AI qualitative response example:

“It’s very convenient, because like I said, you don’t have to leave the house to go to some office in order to get it done”.

Operationalisation learnings will allow for implementation improvements of future embedded interviews.

CONCLUSIONS

Seeking the patient experience can provide valuable additional information. Including qualitative interviews alongside quantitative questionnaires increases response understanding. However, proactive consideration of the operationalisation of embedded interviews is necessary.