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

David Bernstein,Ian D Pavord,Kenneth R Chapman,Richard Follows,Jane H Bentley,Isabelle Pouliquen,Eric Bradford

doi:10.1080/02770903.2019.1630641

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.

Highlights

5–10% of patients with asthma have severe disease, which is defined as asthma that requires treatment with high-dose inhaled corticosteroids (ICS) plus a second controller and/or systemic corticosteroids to maintain control or that remains uncontrolled despite these treatments [1]
An associated study conducted in 56 patients, which assessed the self-administration of mepolizumab using a single-use prefilled syringe (PFS), demonstrated comparable results, whereby all 55 patients/caregivers who completed the second/third injections were able to successfully self-administer their second and third doses of mepolizumab, at home and in-clinic, respectively [12]
These studies showed that a single training session and the instructions for use (IFU) were sufficient for patients/caregivers to acquire the skills necessary to successfully self-administer mepolizumab, either with a PFS or with an AI

Summary

Introduction

5–10% of patients with asthma have severe disease, which is defined as asthma that requires treatment with high-dose inhaled corticosteroids (ICS) plus a second controller and/or systemic corticosteroids to maintain control or that remains uncontrolled despite these treatments [1]. Severe asthma is a heterogeneous disease and several clinical phenotypes have been identified, one of which is severe eosinophilic asthma (SEA) [1,2]. Patients with SEA experience recurrent exacerbations and persistent eosinophilic airway inflammation, typically driven by T2 interleukins (IL) such as IL-5 and IL-13 [1,2]. During its clinical development program in patients with SEA, mepolizumab was well-tolerated, reduced exacerbation rates, decreased oral glucocorticoid dependence, improved lung function, increased asthma control, and improved health-related quality of life compared with placebo [5,6,7,8]. Mepolizumab is approved for use as an add-on treatment for patients with SEA (100 mg subcutaneously [SC]) and for patients with eosinophilic granulomatosis with polyangiitis (300 mg SC) once every 4 weeks [3,4].

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Discussion

Conclusion