Omalizumab in patients with severe asthma: the XCLUSIVE study


  • Authorship and contributorship
    Christian Schumann and Claus Kroegel wrote the manuscript; Cornelia Kropf, Thomas Wibmer, Stefan Rüdiger, Kathrin Magdalena Stoiber, Antje Thielen and Wolfgang Rottbauer analyzed the data, performed the statistics and collaborated in the literature research.

  • Ethics
    All subjects gave written informed consent prior to their inclusion in the study, and the study was approved by the local ethical committee in accordance with the standards laid down in the Declaration of Helsinki

  • Conflict of interest
    CS has received reimbursement from Novartis for attending scientific conferences and holding talks. CK has been financially compensated by Novartis for giving talks at scientific conferences and for consultations. TW, SR and KS have no conflicts. SS and AT are employees at Novartis Pharma GmbH. The Clinic of Internal Medicine II at the University Clinic Ulm and the Pulmonary Department at the University Medical Clinic of the Friedrich-Schiller-University Jena received funds for services performed for participation in single- and multi-centre clinical phase I–IV trials organised by various pharmaceutical companies.

Christian Schumann, MD, University of Ulm Medical Center, Department of Internal Medicine II, Albert-Einstein-Allee 23, 89081, Ulm, Germany, Tel: +49 731 500 45022, Fax: +49 731 500 45023, email:


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 1 s (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.

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. Clin Respir J 2011; DOI:10.1111/j.1752-699X.2011.00263.x.