Open AccessOmalizumab in patients with severe asthma: the XCLUSIVE study
Author(s) -
Schumann Christian,
Kropf Cornelia,
Wibmer Thomas,
Rüdiger Stefan,
Stoiber Kathrin Magdalena,
Thielen Antje,
Rottbauer Wolfgang,
Kroegel Claus
Publication year - 2012
Publication title -
the clinical respiratory journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.789
H-Index - 33
eISSN - 1752-699X
pISSN - 1752-6981
DOI - 10.1111/j.1752-699x.2011.00263.x
Subject(s) - medicine , omalizumab , exacerbation , asthma , immunoglobulin e , randomized controlled trial , clinical trial , clinical practice , physical therapy , antibody , immunology
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 (FEV 1 ), 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 (FEV 1 +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 FEV 1 , 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.