Single-Use Autoinjector Functionality And Reliability For At-Home Administration Of Benralizumab For Patients With Severe Asthma: GRECO Trial Results
Authors Ferguson GT, Cole J, Aurivillius M, Roussel P, Barker P, Martin UJ
Received 31 July 2019
Accepted for publication 1 October 2019
Published 23 October 2019 Volume 2019:12 Pages 363—373
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Melinda Thomas
Peer reviewer comments 3
Editor who approved publication: Dr Luis Garcia-Marcos
Gary T Ferguson,1 Jeremy Cole,2 Magnus Aurivillius,3 Paul Roussel,4 Peter Barker,4 Ubaldo J Martin4
On behalf of the GRECO study investigators
1Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA; 2OK Clinical Research, LLC, Edmond, OK, USA; 3AstraZeneca, Mölndal, Sweden; 4AstraZeneca, Gaithersburg, MD, USA
Correspondence: Gary T Ferguson
Pulmonary Research Institute of Southeast Michigan, 29255 West 10 Mile Road, Suite A, Farmington Hills, MI 48336, USA
Purpose: Accessorized prefilled syringes (APFS) have demonstrated functionality and reliability for subcutaneous (SC) delivery, including self-administration, of benralizumab 30 mg in the clinic or at home. The multicenter, open-label GRECO study (NCT02918071) assessed functionality and reliability of a single-use autoinjector (AI) for at-home benralizumab administration by patients or their caregivers.
Patients and methods: Adults with severe asthma received benralizumab SC injections at the study site at Weeks 0, 4, and 8. The first dose was administered by health care providers. Patients/caregivers had the option of administering the second dose and were required to administer the third dose under supervision. At Weeks 12 and 16, patients/caregivers administered benralizumab via AI at home. After each administration, patients/caregivers completed questionnaires concerning administration and device functioning. All AI devices used were returned for evaluation.
Results: A total of 595 AIs were used for 121 patients (mean age 48.5 years; 64% female) in the clinic and at home. Of 116 participants, 113 (97.4%; 95% confidence interval [CI]: 92.63–99.46) and 112 (96.6%; 95% CI: 91.41–99.05) successfully administered benralizumab at home at Weeks 12 and 16, respectively; 108 (93.1%; 95% CI: 86.86–96.98) were successful on both occasions. Throughout the study, 10 (1.7%) AI administrations were unsuccessful: 8 (1.3%) because of user error, 1 (0.2%) with undetermined cause, and 1 (0.2%) because of a manufacturing defect. Benralizumab efficacy (assessed by Asthma Control Questionnaire 6 score) and pharmacokinetics for patients using the AI were comparable to published results for patients receiving benralizumab via syringe in a clinical setting. No new or unexpected safety findings were observed.
Conclusion: AIs were functional, reliable, and performed well in the clinic and at home. Nearly all patients and caregivers successfully administered SC benralizumab via AI. Benralizumab availability in AI and APFS could provide patients with choices for self-administration.
Keywords: Autoinjector, benralizumab, biologic, clinical trial, delivery system, eosinophil, prefilled syringe, subcutaneous
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