Omalizumab in patients with severe asthma: the XCLUSIVE study
The Clinical Respiratory Journal, 03/12/2012
Schumann C et al. – Results of effectiveness strongly suggest that the efficacy demonstrated in randomised controlled trials (RCTs) can be transposed to a clinical practice–related setting.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.
- 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.