Single‐Use Autoinjector Functionality and Reliability for At‐Home Benralizumab Administration: GRECO Trial Results: 289

Abstract

Peter Barker, Gary T. Ferguson, Jeremy Cole, Magnus Aurivillius, Paul Roussel, and Ubaldo Martin; AstraZeneca, Gaithersburg, MD, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, OK Clinical Research, LLC, Edmond, OK, AstraZeneca, M€olndal, Sweden, MedImmune LLC, Gaithersburg, MD. RATIONALE: Accessorized pre-filled syringes (APFS) are functional and reliable for delivery of benralizumab subcutaneously (SC) in the clinic or at home, as demonstrated by the GREGALE study (NCT02417961). The multicenter, open-label GRECO study (NCT02918071) was designed to assess functionality and reliability of single-use autoinjectors (AI) for athome benralizumab administration. METHODS: Adults with severe asthma received benralizumab SC injections at the study site (Weeks 0, 4, and 8). First doses were administered by health care providers. Patients/caregivers used AI to administer the second (optional) and third doses under supervision. Patients/caregivers administered 2 benralizumab doses (Weeks 12 and 16) with AI at home. After each dose, patients/caregivers completed questionnaires concerning administration and device functioning and had study site visits within 48 hours. RESULTS: In total, 121 patients (mean age 48.5 years; 64% female) used 595 AI. Of 116 participants at Weeks 12 and 16, 113 (97.4%; 95% CI: 92.63–99.46) and 112 (96.6%; 95% CI: 91.41–99.05), respectively, successfully administered benralizumab at home; 108 (93.1%; 95% CI: 86.86–96.98) were successful on both occasions. Throughout the study, 10 (1.7%) unsuccessful AI administrations occurred: 8 (1.3%) because of user error, 1 (0.2%) with undetermined cause, and 1 (0.2%) caused by a manufacturing defect. No new or unexpected safety findings were observed. CONCLUSIONS: Similar to the results for APFS in GREGALE, AI in GRECO were functional, reliable, and performed well in clinic and home settings. Nearly all patients and caregivers successfully administered benralizumab SC with AI.