PMID- 27819161
OWN - NLM
STAT- MEDLINE
DCOM- 20170915
LR  - 20181202
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 33
IP  - 2
DP  - 2017 Feb
TI  - Performance of the pegfilgrastim on-body injector as studied with placebo buffer 
      in healthy volunteers.
PG  - 379-384
LID - 10.1080/03007995.2016.1257980 [doi]
AB  - 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/m(2), 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.
FAU - Joshi, Rajeshree S
AU  - Joshi RS
AD  - a Medical Sciences, Amgen Inc. , Thousand Oaks , CA , USA.
FAU - Egbuna, Ogo I
AU  - Egbuna OI
AD  - a Medical Sciences, Amgen Inc. , Thousand Oaks , CA , USA.
FAU - Cairns, Alex S
AU  - Cairns AS
AD  - b Global Operations, Amgen Inc. , Thousand Oaks , CA , USA.
FAU - Friedman, Michael J
AU  - Friedman MJ
AD  - c Device Technologies, Amgen Inc. , Thousand Oaks , CA , USA.
FAU - Abosaleem, Bassam
AU  - Abosaleem B
AD  - a Medical Sciences, Amgen Inc. , Thousand Oaks , CA , USA.
FAU - Reiner, Maureen T
AU  - Reiner MT
AD  - d Global Biostatistical Science, Amgen Inc. , Thousand Oaks , CA , USA.
FAU - Morrow, Phuong Khanh
AU  - Morrow PK
AD  - e Global Development, Amgen Inc. , Thousand Oaks , CA , USA.
LA  - eng
PT  - Journal Article
DEP - 20161202
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Placebos)
RN  - 0 (Recombinant Proteins)
RN  - 143011-72-7 (Granulocyte Colony-Stimulating Factor)
RN  - 3A58010674 (pegfilgrastim)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - PVI5M0M1GW (Filgrastim)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Female
MH  - Filgrastim
MH  - Granulocyte Colony-Stimulating Factor/*administration & dosage/adverse effects
MH  - Healthy Volunteers
MH  - Humans
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Neutropenia/chemically induced/*prevention & control
MH  - Placebos
MH  - Polyethylene Glycols
MH  - Recombinant Proteins/administration & dosage/adverse effects
OTO - NOTNLM
OT  - Granulocyte colony-stimulating factor
OT  - injector performance
OT  - on-body injector
OT  - pegfilgrastim
EDAT- 2016/11/08 06:00
MHDA- 2017/09/16 06:00
CRDT- 2016/11/08 06:00
PHST- 2016/11/08 06:00 [pubmed]
PHST- 2017/09/16 06:00 [medline]
PHST- 2016/11/08 06:00 [entrez]
AID - 10.1080/03007995.2016.1257980 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2017 Feb;33(2):379-384. doi: 10.1080/03007995.2016.1257980. 
      Epub 2016 Dec 2.