Omalizumab in patients with allergic (IgE-mediated) asthma and IgE/bodyweight combinations above those in the initially approved dosing table

Abstract Background When first approved in the European Union (EU), the omalizumab dosing table had upper bodyweight and IgE limits of 150 kg and 700 IU/mL, respectively. In this study, we assessed the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of omalizumab in patients with IgE/bodywei...

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Bibliographic Details
Published in:Pulmonary pharmacology & therapeutics 2014-08, Vol.28 (2), p.149-153
Main Authors: Kornmann, Oliver, Watz, Henrik, Fuhr, Rainard, Krug, Norbert, Erpenbeck, Veit J, Kaiser, Guenther
Format: Article
Language:English
Subjects:
Adolescent
Adult
Anti-Asthmatic Agents - administration & dosage
Anti-Asthmatic Agents - adverse effects
Anti-Asthmatic Agents - pharmacokinetics
Antibodies, Anti-Idiotypic - administration & dosage
Antibodies, Anti-Idiotypic - adverse effects
Antibodies, Monoclonal, Humanized - administration & dosage
Antibodies, Monoclonal, Humanized - adverse effects
Antibodies, Monoclonal, Humanized - pharmacokinetics
Asthma - drug therapy
Asthma - immunology
Body Weight
Bodyweight
Dose-Response Relationship, Drug
Humans
IgE
Immunoglobulin E - immunology
Medical Education
Middle Aged
Omalizumab
Patient Selection
PK/PD
Pulmonary/Respiratory
Young Adult
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Summary:Abstract Background When first approved in the European Union (EU), the omalizumab dosing table had upper bodyweight and IgE limits of 150 kg and 700 IU/mL, respectively. In this study, we assessed the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of omalizumab in patients with IgE/bodyweight combinations above those in the original dosing table. Methods A multicentre, open-label, parallel-group study assessed the safety, PK and PD of omalizumab in 32 patients with mild-to-moderate allergic (IgE-mediated) asthma. Patients received two subcutaneous injections of omalizumab at one of three dosage levels (450, 525, or 600 mg), chosen according to baseline IgE (300–2000 IU/mL) and bodyweight (40–150 kg), with a 14-day interval between injections. Results Overall, 69 adverse events (AEs), none of them serious, were reported by 26 (81.3%) patients. Analysis of laboratory measurements, vital signs and ECG data revealed no adverse findings of clinical relevance. The PK profile was consistent with previous data for lower doses. Mean maximum decrease of free IgE from screening was ≥99% for all three doses, and mean free IgE concentrations remained
ISSN:1094-5539
1522-9629
DOI:10.1016/j.pupt.2014.03.003