Performance of the pegfilgrastim on-body injector as studied with placebo buffer in healthy volunteers

Abstract

Objective: The pegfilgrastim on-body injector (OBI) is a single-use, disposable, battery-powered injector that is designed to automatically deliver a single subcutaneous dose of pegfilgrastim beginning approximately 27 hours after activation and continuing over approximately 45 minutes. In this open-label study, we assessed performance of the OBI delivering placebo buffer in healthy volunteers.

Research design and methods: Healthy men and women aged 18–55 years, with a body mass index of 18–35 kg/m², were enrolled. OBIs were activated by filling them with placebo buffer, and two injectors were applied concurrently to each subject: one to the abdomen and one to the back of the upper arm. Subjects were monitored for substantial leakage during and after administration.

Main outcome measures: The primary endpoint of the study was successful delivery of placebo buffer based on a composite of the following: no substantial leakage during or after administration, green status light indicator on the injector during and after administration, and fill indicator bar at the empty position after administration. The secondary endpoint was the incidence of treatment-emergent adverse events (AEs).

Results: Of the 150 subjects enrolled, 149 (99.3%) completed the study. Study subjects were 48.0% men, and 52.0% women; 47.3% were white, 35.3% black or African American, 12.7% Asian, and 4.7% other. Mean (SD) age was 35.9 (10.8) years. Of the 297 total deliveries, 292 (98.3%) were considered successful: 147/149 (98.7%; 95% confidence interval [CI]: 95.2%–99.6%) to the abdomen and 145/148 (98.0%; 95% CI: 94.2%–99.3%) to the back of the upper arm. Five deliveries were considered unsuccessful: two due to hazard alarms, and three due to substantial leakage. The most common treatment-emergent AEs (in >2% of subjects overall) by preferred term were medical device site reaction (20.7%), catheter-site hemorrhage (8.7%), and headache (3.3%). No serious AEs were reported.

Conclusions: The pegfilgrastim OBI was well tolerated, and deliveries of placebo buffer were successful 98.3% of the time. The generalizability of these results may be limited by the conduct of this study in healthy subjects in a controlled environment.

Keywords:

• Granulocyte colony-stimulating factor
• injector performance
• on-body injector
• pegfilgrastim

Notes

Transparency

Declaration of funding

This study was funded by Amgen Inc.

Declaration of financial/other relationships

R.S.J., O.I.E., A.S.C., M.J.F., B.A., M.T.R., and P.K.M. have disclosed that they were employees of and owned stock in Amgen Inc. at the time the study was conducted.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Micah Robinson (Amgen Inc.) provided medical writing support.

Previous presentation:

The results of this study were previously presented in a poster at the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition, New Orleans, LA, USA, 6–10 December 2015.

Notes

1 Neulasta is a registered trademark of Amgen Inc., Thousand Oaks, CA, USA

2 Onpro is a registered trademark of Amgen Inc., Thousand Oaks, CA, USA