Article

Omalizumab in patients with severe persistent allergic asthma in a real-life setting in Germany

{ "0" : "Pulmonary Dept., Mainz University Hospital, Langenbeckstr. 1, 55131 Mainz, Germany" , "1" : "Novartis Pharma GmbH, Roonstr. 25, 90429 Nuremberg, Germany" , "3" : "Asthma" , "4" : "IgE" , "5" : "Omalizumab" , "6" : "Allergy" , "7" : "Therapy"}
Respiratory Medicine DOI:10.1016/j.rmed.2009.05.002 pp.1725-1731

ABSTRACT Omalizumab is a humanized monoclonal anti-immunoglobulin E (IgE) antibody indicated in Europe for the treatment of uncontrolled severe persistent allergic (IgE-mediated) asthma despite optimal therapy with inhaled corticosteroids and long-acting β2 agonists.Between 2005 and 2007 280 patients (58% female, mean age 44 ± 16 yrs., 46% on oral corticosteroids, median serum IgE level 235 IU/ml) who met the EU criteria for add-on therapy with anti-IgE were treated prospectively with omalizumab by 134 physicians as part of a post-marketing surveillance trial and were followed-up for 6 months.The median follow-up time was 195 days, the patients were treated with a median dose of 450 mg omalizumab every 4 weeks. After 6 months there was a marked effect of omalizumab treatment on daily (−76%) and nocturnal symptoms (−84%), exacerbations (−82%), unscheduled health care contacts (−81%), hospitalizations (−78%) and quality of life (Mini-AQLQ: score increase from 2.9 to 4.5). Overall, efficacy of omalizumab was rated as excellent or good by the majority of physicians (82%) and patients (86%). In 19 patients (7%) omalizumab-related adverse events were recorded.This post-marketing surveillance trial confirms the marked and clinically relevant effect of omalizumab on asthma symptoms and level of asthma control in the majority of patients with severe persistent allergic (IgE-mediated) asthma in a real-life situation.

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Keywords

134 physicians
 
19 patients
 
4 weeks
 
450 mg omalizumab
 
6 months.The median follow-up time
 
clinically relevant effect
 
EU criteria
 
humanized monoclonal anti-immunoglobulin E
 
IgE
 
IgE-mediated
 
inhaled corticosteroids
 
long-acting β2 agonists.Between 2005
 
median serum IgE level 235 IU/ml
 
omalizumab treatment
 
optimal therapy
 
oral corticosteroids
 
post-marketing surveillance trial
 
severe persistent allergic
 
uncontrolled severe persistent allergic
 
unscheduled health care contacts