Ease of Use of the Lebrikizumab Prefilled Pen for Individuals with Atopic Dermatitis.

BACKGROUND

Atopic dermatitis (AD) is a chronic inflammatory skin disease that can require long-term systemic therapy in individuals with moderate-to-severe disease. Lebrikizumab is a monoclonal antibody that targets interleukin 13, an important cytokine involved in AD pathogenesis. A single-use, prefilled pen has been developed to enable self-injection, and its usability is the focus of this study. Because ease of use and user confidence are considered important factors in self‑injection experiences, evaluating the usability of injection devices is an important component of patient-centered care. This study assessed the usability of the lebrikizumab prefilled pen in adults with AD in a simulated injection setting using a validated patient-reported questionnaire.

METHODS

In this open-label, single-site, single-visit simulated injection study (NCT06444165), 55 adults with AD performed a simulated injection using a relabeled commercial lebrikizumab prefilled pen (250 mg/2 mL) after training. The injection was performed into an injection pad designed to mimic skin tissue. Participants completed the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ), a 10-item instrument assessing ease of use and confidence. The primary endpoints were responses to 2 questions: "Overall, easy to use" and "Confidence in ability to use the device." All analyses were descriptive.

RESULTS

Among 55 participants, 96.4% agreed or strongly agreed that the pen was "overall, easy to use", and 96.4% agreed or strongly agreed they were "confident in their ability to use the device" based on the mSQAAQ. Over 92% of participants agreed or strongly agreed with each of the remaining mSQAAQ items.

CONCLUSION

The lebrikizumab prefilled pen demonstrated high reported ease of use and user confidence in adults with AD following a trained, simulated injection.