Gary T Ferguson, Adel H Mansur, Joshua S Jacobs, Jacques Hebert, Corbin Clawson, Wenli Tao, Yanping Wu, Mitchell Goldman

Patients prefer at-home subcutaneous administration of biologics across different diseases, yet no biologic is approved for at-home use for severe, uncontrolled asthma. We assessed at-home functionality, reliability, and performance of an accessorized pre-filled syringe (APFS) for subcutaneous benralizumab administration, an anti-eosinophil monoclonal antibody indicated for add-on maintenance treatment of patients with severe eosinophilic asthma. Patients (N=116) with severe, uncontrolled asthma despite receiving medium- or high-dosage inhaled corticosteroids and long-acting β2-agonists received up to 5 APFS-administered subcutaneous doses (Weeks 0, 4, 8, 12, and 16) of benralizumab 30 mg. The first 3 doses were administered at the study sites. The patient/caregiver administered the last 2 doses at home. Endpoints included the percentage of dispensed APFS that were used successfully blood eosinophil counts, Asthma Control Questionnaire 6, and safety. Nearly all dispensed APFS were successfully used in the clinic and at home (Week 0: 116/116, 100%; Week 4: 116/117, 99%; Week 8: 115/115, 100%; Week 12: 112/114, 98%; Week 16: 108/109, 99%). Only 1 APFS malfunctioned out of 573 dispensed. Two at-home administrations were unsuccessful because of patient-use error. One unreturned APFS was recorded as nonfunctional. Mean Asthma Control Questionnaire 6 scores decreased from baseline through all post-baseline time points, and nearly complete depletion of eosinophils was observed at the end of treatment. The most common adverse events were nasopharyngitis, upper respiratory tract infection, headache, and sinusitis. Five patients (4%) experienced transient mild or moderate injection-site reactions. The APFS was functional, reliable, and performed equally well in the clinic and at home.