Usability of mepolizumab single-use prefilled autoinjector for patient self-administration

Abstract

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.

Keywords:

• severe eosinophilic asthma
• self-injected
• device
• at-home
• blood eosinophil count

Acknowledgements

The authors would like to thank the patients and caregivers who took part in this study and Will Williams and Rosalida Leone who were the Study Managers. Editorial support (in the form of writing assistance, including development of the initial draft from the study report, assembling tables and figures, collating authors’ comments, grammatical editing and referencing) was provided by Kerry Knight, PhD, at Fishawack Indicia Ltd, UK, and was funded by GSK.

Declaration of interest

RF, JHB, IP, and EB are employees of GSK and hold stocks/shares. DB received grant/research/clinical trial support from GSK, Teva, AstraZeneca, Pearl, Novartis, Genentech, Lupin, Merck, Mylan, Boehringer Ingelheim, Amgen, Aimmune, Menlo, Shire, Biocryst and consulted/participated in advisory boards for GSK, ALK America, Gerson-Lehman, Guidepoint Global. IDP has received fees for speaking from AstraZeneca, Boehringer Ingelheim, Aerocrine, Almirall, Novartis, Teva, Chiesi, and GSK; fees for organizing educational events from AstraZeneca and Teva, honoraria for attending advisory panels with Genentech, Regeneron, AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Teva, Sanofi, Circassia, Chiesi, Almirall, and Knopp; sponsorship to attend international scientific meetings from Boehringer Ingelheim, GSK, AstraZeneca, Teva, and Chiesi; a research grant from National Institute for Health Research. KRC has received consulting fees from AstraZeneca, Boehringer Ingelheim, CSL Behring, GSK, Grifols, Kamada, Novartis, Roche, and Sanofi Regeneron; has undertaken research funded by Amgen, AstraZeneca, Boehringer Ingelheim, CSL Behring, GSK, Grifols, Kamada, Novartis, Roche and Sanofi; has participated in continuing medical education activities sponsored in whole or in part by AstraZeneca, Boehringer Ingelheim, GSK, Grifols, Novartis, and Teva. KRC is participating in research funded by the Canadian Institutes of Health Research and holds the GSK-CIHR Research Chair in Respiratory Health Care Delivery at the University Health Network, Toronto, Canada.

Author’s contributions

RF, JHB, IP, and EB were involved in the conception or design of the work; DB, IDP, and KRC were involved in the acquisition of data; and all authors participated in data analysis and interpretation of the work. All authors critically revised the manuscript for intellectual content, gave final approval of the version to be published, and agreed to be accountable for all aspects of the work.

Data sharing statement

Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com.

Additional information

Funding

This study was funded by GlaxoSmithKline (GSK ID: 204959; ClinicalTrials.gov number NCT03099096).