Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma

Abstract

Background: Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody in development for the treatment of severe asthma. This study assessed the functionality and performance of an accessorized pre-filled syringe (APFS) and an autoinjector (AI) for administration of tezepelumab in the clinic and at home.

Methods: This phase 3, multicenter, randomized, open-label, parallel-group study (PATH-HOME, ClinicalTrials.gov identifier: NCT03968978) was conducted in patients aged 12-80 years with asthma that was uncontrolled despite treatment with medium- to high-dose inhaled corticosteroids plus at least one additional controller medication. Patients received six subcutaneous doses of tezepelumab 210 mg via APFS or AI. The first dose was administered by a healthcare professional, and patients or caregivers administered subsequent doses. First, second, third and final doses were administered in the clinic; fourth and fifth doses were administered at home. The primary endpoint was the proportion of successful administrations of tezepelumab. Secondary endpoints included the functionality and performance of the devices, Asthma Control Questionnaire (ACQ)-6 score, pharmacokinetics and safety.

Results: Overall, 216 patients were randomized (APFS, n=111; AI, n=105). Tezepelumab was successfully administered via APFS by 91.7% of the participants (100/109) and via AI by 92.4% (97/105). Overall, 95.4-97.1% of at-home administrations were successful across device groups. Malfunction occurred in 6 of 655 dispensed APFSs and 5 of 624 dispensed AIs. Clinically meaningful improvements in ACQ-6 score were observed after 24 weeks in 81.1% and 76.2% of the patients in the APFS and AI groups, respectively. Tezepelumab pharmacokinetics were consistent between device groups and with previous studies. The most common adverse event was nasopharyngitis (9.3%). Injection-site reactions occurred in 5.7% and 0% of the patients in the AI and APFS groups, respectively.

Conclusion: This study demonstrated that the APFS and AI were functional and reliable, and performed equally well at home and in the clinic.

Keywords: accessorized pre-filled syringe; at-home administration; autoinjector; severe asthma; tezepelumab.

Conflict of interest statement

Sady Alpizar is an employee of Clinical Research Trials of Florida and received personal fees from AstraZeneca during the conduct of the PATH-HOME study. Ayman Megally, Claudia Chen, Abhi Raj and Gene Colice are employees of AstraZeneca. John Downie is an employee of Amgen Inc. The authors report no other conflicts of interest in this work.

© 2021 Alpizar et al.

Figures

Figure 1

Study design. *Patient or caregiver to return used APFS or AI and completed questionnaire to the study site.

Figure 2

Proportion of HCPs, patients and caregivers who successfully administered tezepelumab via APFS or AI in (A) the overall population and (B) adolescents only. Values in the bars represent the number of patients who administered study drug successfully out of the total number of patients who received or attempted to receive study drug.

Figure 3

Proportion of patients with well-controlled, partially controlled and not well-controlled asthma at baseline and at week 24, by device group. aData were missing for two patients in the APFS group and the mean ACQ-6 score was not calculated for these patients.