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Dupilumab-Treated Patients with Asthma in the Real World: The RAPID Global Registry.
- Source :
-
Advances in therapy [Adv Ther] 2023 Mar; Vol. 40 (3), pp. 1292-1298. Date of Electronic Publication: 2023 Jan 10. - Publication Year :
- 2023
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Abstract
- Background: Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation. In clinical studies, dupilumab reduced the risk of severe asthma exacerbations, and improved forced expiratory volume in 1 s and quality of life in patients with uncontrolled moderate-to-severe asthma.<br />Objectives: The objectives of RAPID (NCT04287621) are to characterize patients with asthma initiating dupilumab in routine clinical practice and to collect information on long-term effectiveness and safety in these patients.<br />Methods: RAPID is a global, prospective, observational registry that will enroll approximately 1000 patients (aged ≥ 12 years) with asthma from 150 sites globally. Dupilumab treatment will be initiated in routine clinical practice according to country-specific prescribing information, per physician discretion as part of routine care. Patients will be followed prospectively for up to 3 years, with postbaseline assessments at months 1 and 3, and every 3 months thereafter.<br />Planned Outcomes: Baseline data collected will include patient demographics, disease characteristics, and medication history. Patient adherence and persistence will be recorded alongside health-care resource utilization, and effectiveness of dupilumab will be assessed (clinician assessment) as per standard of care. Quality of life, asthma control, type 2 inflammatory comorbidities, work productivity, and physical activity limitation will be assessed. Incidence and severity of adverse events will be recorded.<br />Conclusion: RAPID is the first global registry to characterize patients beginning dupilumab treatment for asthma in clinical practice and will expand on prior clinical studies by providing real-world data.<br />Clinical Trial Registration: ClinicalTrials.gov identifier NCT04287621.<br /> (© 2023. The Author(s).)
Details
- Language :
- English
- ISSN :
- 1865-8652
- Volume :
- 40
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Advances in therapy
- Publication Type :
- Academic Journal
- Accession number :
- 36626107
- Full Text :
- https://doi.org/10.1007/s12325-022-02399-5