Journal
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Volume 149, Issue 2, Pages 488-+Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2021.10.035
Keywords
Severe asthma; precision medicine; adaptive clinical trial design; asthma exacerbation; type 2 asthma; non-type 2 asthma; patient advisory committee; biomarker
Categories
Funding
- National Heart, Lung, and Blood Institute, National Institutes of Health [U24 HL138998, 1UG1HL139054, 1UG1HL139098, 1UG1HL139106, 1UG1HL139117, 1UG1HL139118, 1UG1HL139119, 1UG1HL139123, 1UG1HL139124, 1UG1HL139125, 1UG1HL139126]
- National Institutes of Health Clinical & Translational Science Award grants [UL1TR002451, UL1TR000427, UL1TR002366, UL1TR002389, UL1TR002489, UL1TR001857, UL1TR001442, UL1TR001872]
- Duke/Vanderbilt Trial Innovation Center [5U24TR001608]
- Gloria M. and Anthony C. Simboli Distinguished Chair in Asthma Research
- William W. and Judith H. Busse Professor of Allergy & Asthma Research
- Walter and Carmina Parkes Family Endowed Professorship
Ask authors/readers for more resources
Asthma is a heterogeneous disease that requires individualized treatment based on different pathological mechanisms. The PrecISE Network is a groundbreaking collaborative effort aimed at accelerating the development of therapeutics for severe asthma.
Asthma is a heterogeneous disease, with multiple underlying inflammatory pathways and structural airway abnormalities that impact disease persistence and severity. Recent progress has been made in developing targeted asthma therapeutics, especially for subjects with eosinophilic asthma. However, there is an unmet need for new approaches to treat patients with severe and exacerbation-prone asthma, who contribute disproportionately to disease burden. Extensive deep phenotyping has revealed the heterogeneous nature of severe asthma and identified distinct disease subtypes. A current challenge in the field is to translate new and emerging knowledge about different pathobiologic mechanisms in asthma into patient-specific therapies, with the ultimate goal of modifying the natural history of disease. Here, we describe the Precision Interventions for Severe and/or Exacerbation-Prone Asthma (PrecISE) Network, a groundbreaking collaborative effort of asthma researchers and biostatisticians from around the United States. The PrecISE Network was designed to conduct phase II/proof-of-concept clinical trials of precision interventions in the population with severe asthma, and is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Using an innovative adaptive platform trial design, the PrecISE Network will evaluate up to 6 interventions simultaneously in biomarker-defined subgroups of subjects. We review the development and organizational structure of the PrecISE Network, and choice of interventions being studied. We hope that the PrecISE Network will enhance our understanding of asthma subtypes and accelerate the development of therapeutics for severe asthma.
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