Population-Based Efficacy Modeling of Omalizumab in Patients with Severe Allergic Asthma Inadequately Controlled with Standard Therapy

• Published in: The AAPS journal Vol. 15; no. 2; pp. 559 - 570
• Main Authors: Zhu, Rui, Zheng, Yanan, Putnam, Wendy S., Visich, Jennifer, Eisner, Mark D., Matthews, John G., Rosen, Karin E., D’Argenio, David Z.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.04.2013
• Subjects: Adolescent; Adult; Aged; Anti-Asthmatic Agents - administration & dosage; Anti-Asthmatic Agents - therapeutic use; Antibodies, Anti-Idiotypic - administration & dosage; Antibodies, Anti-Idiotypic - therapeutic use; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - therapeutic use; Asthma - diagnosis; Asthma - drug therapy; Asthma - immunology; Asthma - physiopathology; Biochemistry; Biomarkers - blood; Biomedical and Life Sciences; Biomedicine; Biotechnology; Breath Tests; Child; Computer Simulation; Double-Blind Method; Drug Administration Schedule; Female; Forced Expiratory Volume; Humans; Immunoglobulin E - blood; Lung - drug effects; Lung - physiopathology; Male; Middle Aged; Models, Biological; Monte Carlo Method; Nitric Oxide - metabolism; Omalizumab; Pharmacology/Toxicology; Pharmacy; Prospective Studies; Research Article; Spirometry; Time Factors; Treatment Outcome; Young Adult; population modeling; asthma; FEV1; omalizumab; IgE

Omalizumab, a recombinant humanized monoclonal antibody, is the first approved anti-immunoglobulin E (IgE) agent for the treatment of subjects with moderate to severe persistent allergic asthma that are inadequately controlled by the standard of care. The objective of this study was to quantitativel...