Beschreibung:
<jats:title>Abstract</jats:title><jats:p><jats:bold>Background and Aims: </jats:bold> Although the efficacy and safety of omalizumab (OMA) in uncontrolled severe allergic asthma has been demonstrated in several randomised controlled trials (RCTs), information on the treatment in a practice‐related setting is limited. Thus, the purpose of this prospective multi‐centre study (XCLUSIVE) was to investigate the efficacy, compliance and utilisation of OMA therapy in real‐life clinical practice in Germany.</jats:p><jats:p><jats:bold>Methods: </jats:bold> One hundred ninety‐five asthmatic patients initiated on anti‐Immunoglobulin E (IgE) IgE treatment were followed‐up for 6 months. Forced expiratory volume in 1 s (FEV<jats:sub>1</jats:sub>), exacerbation rate, days of absence, asthma symptoms [Asthma Control Questionnaire (ACQ)], a Global Evaluation of Treatment Effectiveness (GETE) and medication use were assessed.</jats:p><jats:p><jats:bold>Results: </jats:bold> Measured outcome variables improved after a 16‐week treatment period with OMA (FEV<jats:sub>1</jats:sub>+13.7% predicted <jats:italic>P</jats:italic> < 0.05, exacerbation rate −74.9% <jats:italic>P</jats:italic> < 0.0001, days of absence −92.1% <jats:italic>P</jats:italic> < 0.001, ACQ −43.7% <jats:italic>P</jats:italic> < 0.0001). Investigators evaluated the effectiveness of OMA by GETE in 78.8% as excellent or good (responder), and in 12.6%/8.6% as moderate/poor or worse (non‐responder). Responders demonstrated better improvement of FEV<jats:sub>1</jats:sub>, exacerbation rate, days of absence, ACQ and reduction of oral corticosteroids compared with non‐responders.</jats:p><jats:p><jats:bold>Conclusion: </jats:bold> Results of effectiveness strongly suggest that the efficacy demonstrated in RCTs can be transposed to a clinical practice‐related setting.</jats:p><jats:p>Please cite this paper as: Schumann C, Kropf C, Wibmer T, Rüdiger S, Stoiber KM, Thielen A, Rottbauer W and Kroegel C. Omalizumab in patients with severe asthma: the XCLUSIVE study. <jats:italic>Clin Respir J</jats:italic> 2011; DOI:10.1111/j.1752‐699X.2011.00263.x.</jats:p>