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.

Role of thymic stromal lymphopoietin in allergy and beyond

“…2020 Adolescents and adults with severe asthma Tezepelumab administered by APFS versus AI APFS and AI were functional and reliable, and performed equally well at home and in the clinic NCT03968978 (ref. 185 ) Efficacy and safety of tezepelumab in reducing oral corticosteroid use, phase III (SOURCE) Completed Sep. 2020 Adults with oral corticosteroid-dependent asthma Tezepelumab versus placebo NA NCT03406078 (ref. 186 ) Efficacy and safety of tezepelumab, phase III (NAVIGATOR) Completed Nov. 2020 Adults and adolescents with severe uncontrolled asthma Tezepelumab versus placebo Tezepelumab associated with fewer exacerbations and better lung function, asthma control and health-related quality of life than placebo NCT03347279 (ref.…”

The efficacy and safety of tezepelumab in the treatment of uncontrolled asthma: A systematic review and meta-analysis of randomized controlled trials

“…Our meta-analysis indicated that 49.5% of the 216 patients in the PATHHOME study (phase 3, open-label) reported experiencing all adverse events, with similar frequencies observed in the 2 device groups. [23] The pooled results of 1 study indicated that the incidence of any adverse events among the overall participants treated with either tezepelumab, dupilumab, benralizumab, mepolizumab, or placebo was similar. [21] The overall safety profile of tezepelumab was comparable to that of placebo in all RCTs, with the most common adverse events being asthma, nasopharyngitis, headache, upper respiratory tract infection, and bronchitis.…”

Biologic Therapies for Asthma and Allergic Disease: Past, Present, and Future

“…Nasopharyngitis was reported as the most common adverse effect (9.3%). Injection-site reactions occurred in 5.7% (AI) and 0% (AFPS) of the patients [ 112 ]. Taken together, these results from phase 2/3 trials suggest that blocking the upstream alarmin TSLP with tezepelumab results in clinically meaningful improvements in asthma control in patients with T2-high asthma concerning exacerbations.…”