PMID- 31251090
OWN - NLM
STAT- MEDLINE
DCOM- 20210303
LR  - 20210303
IS  - 1532-4303 (Electronic)
IS  - 0277-0903 (Linking)
VI  - 57
IP  - 9
DP  - 2020 Sep
TI  - Usability of mepolizumab single-use prefilled autoinjector for patient 
      self-administration.
PG  - 987-998
LID - 10.1080/02770903.2019.1630641 [doi]
AB  - Objective: To evaluate usability of mepolizumab as a liquid drug product 
      self-administered via a single-use prefilled autoinjector (AI) by patients with 
      severe eosinophilic asthma (SEA), or their caregivers, in-clinic and at 
      home.Methods: This open-label, single-arm, Phase IIIa study (NCT03099096; GSK ID: 
      204959) included patients aged >/=12 years with SEA who were either receiving 
      mepolizumab (100 mg subcutaneously [SC]) every 4 weeks (Q4W) for >/=12 weeks before 
      screening or not receiving mepolizumab but met criteria indicative of SEA. 
      Patients/caregivers self-administered mepolizumab (100 mg SC) via an AI Q4W for 
      12 weeks. The first (Week 0) and third (Week 8) doses were observed in-clinic; 
      the second dose (Week 4) was administered unobserved at home. Primary and 
      secondary endpoints were the proportion of patients who successfully 
      self-administered their third and second doses, respectively (determined by 
      investigator/site staff). Patient experience, mepolizumab trough concentrations, 
      blood eosinophil count (BEC), and safety were also assessed.Results: Of 159 
      patients/caregivers who self-administered >/=1 dose of mepolizumab, 157 completed 
      the study. Nearly all patients successfully self-administered their third 
      mepolizumab dose in-clinic and second dose at home (>/=98% and >/=96%, respectively); 
      this was further confirmed by mepolizumab trough concentrations/BEC. At study 
      end, >/=88% of patients were "very" or "extremely" confident about using the AI 
      correctly. Incidence of on-treatment drug-related adverse events (AEs) was low 
      (3%); no fatal AEs occurred.Conclusions: Patients/caregivers successfully 
      self-administered mepolizumab via the AI both in-clinic and at home; no new 
      safety concerns were identified.
FAU - Bernstein, David
AU  - Bernstein D
AD  - Department of Medicine, University of Cincinnati, Cincinnati, OH, USA.
FAU - Pavord, Ian D
AU  - Pavord ID
AD  - Nuffield Department of Medicine and Oxford Respiratory NIHR BRC, University of 
      Oxford, Oxford, UK.
FAU - Chapman, Kenneth R
AU  - Chapman KR
AD  - Asthma & Airway Centre, UHN and University of Toronto, Toronto, ON, Canada.
FAU - Follows, Richard
AU  - Follows R
AD  - Respiratory Therapeutic Area, GSK, Stockley Park, Uxbridge, UK.
FAU - Bentley, Jane H
AU  - Bentley JH
AD  - Clinical Statistics, GSK, Stockley Park, Uxbridge, UK.
FAU - Pouliquen, Isabelle
AU  - Pouliquen I
AD  - Clinical Pharmacology Modelling & Simulation, GSK, Stockley Park, Uxbridge, UK.
FAU - Bradford, Eric
AU  - Bradford E
AD  - Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03099096
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20190628
PL  - England
TA  - J Asthma
JT  - The Journal of asthma : official journal of the Association for the Care of 
      Asthma
JID - 8106454
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 90Z2UF0E52 (mepolizumab)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Asthmatic Agents/*administration & dosage/adverse effects
MH  - Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects
MH  - Asthma/*drug therapy
MH  - Child
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology/etiology
MH  - Feasibility Studies
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Injections, Subcutaneous/instrumentation
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Self Administration/adverse effects/*instrumentation
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - at-home
OT  - blood eosinophil count
OT  - device
OT  - self-injected
OT  - severe eosinophilic asthma
EDAT- 2019/06/30 06:00
MHDA- 2021/03/04 06:00
CRDT- 2019/06/29 06:00
PHST- 2019/06/30 06:00 [pubmed]
PHST- 2021/03/04 06:00 [medline]
PHST- 2019/06/29 06:00 [entrez]
AID - 10.1080/02770903.2019.1630641 [doi]
PST - ppublish
SO  - J Asthma. 2020 Sep;57(9):987-998. doi: 10.1080/02770903.2019.1630641. Epub 2019 
      Jun 28.