Omalizumab in patients with severe asthma: The XCLUSIVE study

Abstract

Background and Aims: 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. Methods: One hundred ninety-five asthmatic patients initiated on anti-Immunoglobulin E (IgE) IgE treatment were followed-up for 6 months. Forced expiratory volume in 1s (FEV1), exacerbation rate, days of absence, asthma symptoms [Asthma Control Questionnaire (ACQ)], a Global Evaluation of Treatment Effectiveness (GETE) and medication use were assessed. Results: Measured outcome variables improved after a 16-week treatment period with OMA (FEV1+13.7% predicted P<0.05, exacerbation rate -74.9% P<0.0001, days of absence -92.1% P<0.001, ACQ -43.7% P<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 FEV1, exacerbation rate, days of absence, ACQ and reduction of oral corticosteroids compared with non-responders. Conclusion: Results of effectiveness strongly suggest that the efficacy demonstrated in RCTs can be transposed to a clinical practice-related setting. © 2011 Blackwell Publishing Ltd.