title: Biomarkers in the clinical development of asthma therapies.
abstract: Here we review how biomarkers have been used in the design, execution and interpretation of recent clinical studies of therapeutic candidates targeting cytokine-mediated inflammatory pathways in asthma. This review focuses on type 2 inflammation, as there are multiple therapeutics and/or clinical studies that can be compared within that specific pathway. Comparative analyses of data from these clinical studies illustrate the utility of biomarkers to quantify pharmacodynamic effects, clarify mechanism of action and stratify patients, which may facilitate the interpretation of outcomes in the development of molecularly targeted therapies. These case examples provide a basis for biomarker considerations in the design of future studies in the asthma setting.
authors.affiliation: Department of OMNI Biomarker Development, Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Tracy L
authors.initials: TL
authors.lastname: Staton
authors.affiliation: Department of Biomarker Discovery OMNI, Genentech, Inc., South San Francisco, CA, USA.
authors.forename: David F
authors.initials: DF
authors.lastname: Choy
authors.affiliation: Department of Immunology Discovery, Genentech, Inc., South San Francisco, CA, USA.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Arron
mesh_terms: D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D054316:Biomarkers, Pharmacological / Q000097:blood*; D017322:Clinical Trials, Phase II as Topic; D006801:Humans; D007249:Inflammation / Q000378:metabolism*; D007378:Interleukins / Q000378:metabolism*; D058990:Molecular Targeted Therapy; D015398:Signal Transduction; D016896:Treatment Outcome
chemical_list: D018927:Anti-Asthmatic Agents; D000911:Antibodies, Monoclonal; D054316:Biomarkers, Pharmacological; D007378:Interleukins
keywords: AMG 317; FeNO; GSK679586; asthma; benralizumab; biomarkers; brodalumab; dupilumab; eosinophils; golilumab; lebrikizumab; mepolizumab; omalizumab; patient selection; periostin; pharmacodynamics; reslizumab; tralokinumab