Performance characterization of spring-actuated prefilled pen devices for lebrikizumab and dupilumab.

Abstract

Background: Design parameters of prefilled pens, known as autoinjectors within the medical device community, can affect pen's functioning and user experience. This study compares the performance of two 2 mL prefilled pen devices: lebrikizumab (125 mg/mL) and dupilumab (150 mg/mL).

Research design and methods: We recorded force and acoustic signals during administration from the prefilled pen devices and performed high-speed video recording during needle insertion and drug delivery. Measurements were reported in these categories: (i) The kinematics of needle movement during insertion captured by two cameras (ii) Injection flow rate and duration, and the time between acoustic 1st (activation) click and 2nd click sounds (iii) Post-2nd click injection duration, and (iv) delivered dose volume. We investigated the impact of temperature on device performance by experimenting at room temperature (~25℃) and cool condition (~5℃).

Results: The lebrikizumab device demonstrated faster injection and more reliable end-of-dose indication, while the dupilumab device showed less lateral needle movement in air during insertion. The device activation forces are provided.

Conclusion: Our investigation uncovered performance distinctions between lebrikizumab and dupilumab prefilled pens, which could potentially translate into patient experience, and varying levels of risk associated with intramuscular injection for the adult population and premature device removal.