ArticleJournal of asthma and allergy2021
Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma.
Article in Journal of asthma and allergy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03968978 (A Multicenter, Randomized, Open-label, Parallel Group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector With Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects With Severe Asthma), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Open-label, Parallel Group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector With Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects With Severe Asthma (PATH-HOME)
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- Incidence of Anti-Drug Antibodies to Monoclonal Antibodies in Asthma: A Systematic Review and Meta-Analysis.The journal of allergy and clinical immunology. In practice · 2023Pooled it
- Age-specific efficacy of biologics in severe asthma: a pediatric perspective.Frontiers in allergy · 2026Review
- Systematic literature review of asthma biologic self-administration enhanced by a patient perspective.The journal of allergy and clinical immunology. Global · 2024Article
- Tezepelumab for Severe Asthma: One Drug Targeting Multiple Disease Pathways and Patient Types.Journal of asthma and allergy · 2024Review
- [Tezepelumab: a new option for the treatment of severe asthma].Revista medica del Instituto Mexicano del Seguro Social · 2023Review
- Developments in the Management of Severe Asthma in Children and Adolescents: Focus on Dupilumab and Tezepelumab.Paediatric drugs · 2023Review
- Severe Asthma and Biological Therapies: Now and the Future.Journal of clinical medicine · 2023Review
- Review
- Biologic Therapies for Asthma and Allergic Disease: Past, Present, and Future.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Role of thymic stromal lymphopoietin in allergy and beyond.Nature reviews. Immunology · 2023Review
- Tezepelumab: First Approval.Drugs · 2022Review
- Dupilumab and tezepelumab in severe refractory asthma: new opportunities.Therapeutic advances in chronic disease · 2022Review
- Targeting TSLP in Asthma.Journal of asthma and allergy · 2022Review
- Efficacy and Potential Positioning of Tezepelumab in the Treatment of Severe Asthma.Open respiratory archivesReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTezepelumab 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.
methodsThis 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.
resultsOverall, 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.
conclusionThis study demonstrated that the APFS and AI were functional and reliable, and performed equally well at home and in the clinic.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.