Phenotypes | Patients | Asthma-related outcomes | Results | References |
Allergic asthma (adults) | Placebo-controlled (n=850), 48 weeks; uncontrolled asthma with high-dose ICS+LABA with/without additional controllers | Rate of exacerbations | Incidence rate 0.66 versus 0.88 (omalizumab versus placebo), p=0.006 | Hanania et al. 2011 [161] |
Placebo-controlled (n=419), 28 weeks; uncontrolled asthma with high-dose ICS+LABA with/without additional controllers | Exacerbation requiring systemic corticoids | Exacerbation rate 0.68 versus 0.91 (omalizumab versus placebo), p=0.42 | Humbert et al. 2005 [1] | |
Allergic asthma (6–20 years old) | Placebo-controlled (n=419); patients receiving long-term therapy with symptoms or evidence of uncontrolled disease as indicated by hospitalisation or unscheduled urgent care in the previous 6–12 months, and patients without control therapy if they had persistent symptoms and uncontrolled asthma | Days without asthma symptoms during last 2 weeks, as assessed every 4 weeks | Mean days with symptoms 1.48 versus 1.96 (omalizumab versus baseline); 24.5% reduction as compared with placebo group, p<0.001 | Busse et al. 2011 [65] |
Nonallergic asthma (serum IgE 30–700 kU·L−1) | Uncontrolled nonatopic asthma (n=41) despite daily high-dose ICS treatment (>1000 μg BDP or equivalent per day)+LABA with/without maintenance OCS | Change from baseline in FcεRI expression on basophils and plasmacytoid dendritic cells (pDC2) after 16 weeks; secondary end-points: lung function, asthma control score, GETE, exacerbation rate and FeNO | Significant median change in FcεRI expression on basophils (p<0.001) and plasmacytoid dendritic cells (pDC2) (p<0.001) between omalizumab group versus placebo group; compared with placebo, the omalizumab group showed a statistically significant (p=0.029) increase in mean FEV1 after 16 weeks | Garcia et al. 2013 [160] |
Allergic and nonallergic asthma | Chronic rhinosinusitis with nasal polyposis with concomitant asthma (n=23; atopic n=13, nonatopic n=10) | Asthma symptoms, lung function and quality-of-life scores | Improvement of asthma symptoms score after 16 weeks omalizumab as compared with placebo group; wheezing (p<0.02) and dyspnoea (p<0.03) | Gevaert et al. 2013 [121] |
Occupational asthma to both high- and low-molecular weight chemicals | Occupational asthma despite workplace adjustments Severe uncontrolled asthma with high-dose ICS (mean BDP: 3200 μg)+LABA | FEV1, asthma control, exacerbation rate, ICS daily dose and OCS daily dose | Seven out of 10 occupational asthma patients remained at work; compared with baseline, ICS daily dose was lower in five out of the 10 patients; two out of these five had their OCS therapy withdrawn; exacerbation rate fell from 5.2 to 0.5 year–1 | Lavaud et al. 2013 [162] |
ICS: inhaled corticosteroid; LABA: long-acting β-agonist; BDP: beclometasone dipropionate; OCS: oral corticosteroid; GETE: physician and patient global evaluation of treatment effectiveness; FeNO: exhaled nitric oxide fraction; FEV1; forced expiratory volume in 1 s.