First author [Ref.] | Population | Patients n | Treatment groups | Rhinitis at baseline n (%) | Treatment duration weeks | Outcome |
Humbert [42] | Severe allergic asthma | 419 | Omalizumab + ICS | Not available | 28 | Clinically significant exacerbation rate/patient: omalizumab 0.68, placebo 0.91, p = 0.042 |
Placebo + ICS | Severe exacerbation rate/patient: omalizumab 0.24, placebo 0.48, p = 0.002 | |||||
Ayres [43] | Moderate/severe allergic asthma | 312 | Omalizumab + CAT | 205 (66)# | 52 | Asthma deterioration incident rate·yr−1: omalizumab 4.92, control 9.76, p<0.001 |
CAT | Exacerbations·patient·yr−1: omalizumab 1.12, control 2.86, p<0.001 | |||||
Vignola [9] | Moderate/severe asthma and persistent allergic rhinitis | 405 | Omalizumab + ICS | 405 (100)¶ | 28 | Patients with exacerbations: omalizumab 21%, placebo 30%, p = 0.02 |
Placebo + ICS | ||||||
Busse [44] | Moderate/severe allergic asthma | 525 | Omalizumab + ICS | 518 (99)# | 28 | Exacerbations/patient in stable steroid phase (16 weeks): omalizumab 0.28, placebo 0.54, p = 0.006 |
Placebo + ICS | Exacerbations/patient in steroid reduction phase (12 weeks): omalizumab 0.39, placebo 0.66, p = 0.003 | |||||
Lanier [45] | Moderate/severe allergic asthma | 460 | Omalizumab + ICS | Not available | 24-week extension | Exacerbations/patient: omalizumab 0.60, placebo 0.83, p = 0.023 |
Placebo + ICS | ||||||
Solèr [39] | Moderate/severe allergic asthma | 546 | Omalizumab + ICS | 478 (88)# | 28 | Exacerbations/patient in stable steroid phase (16 weeks): omalizumab 0.28, placebo 0.66, p<0.001 |
Placebo + ICS | Exacerbations/patient in steroid reduction phase (12 weeks): omalizumab 0.36, placebo 0.75, p<0.001 | |||||
Buhl [40] | Moderate/severe allergic asthma | 483 | Omalizumab + ICS | Not available | 24-week extension | Exacerbations/patient: omalizumab 0.48, placebo 1.14, p<0.001 |
Placebo + ICS | ||||||
Holgate [46] | Severe allergic asthma | 246 | Omalizumab + ICS | 203 (83)# | 32 | Reduction in fluticasone dose: omalizumab 57%, placebo 43.3%, p = 0.003 |
Placebo + ICS | ||||||
ALTO [47] | Severe asthma | 1760 | Omalizumab + CAT | 1561 (89)# | 24 | Exacerbation rate·yr·patient−1: omalizumab 1.02, control 1.20, p = 0.08 |
CAT |
Additional data on numbers of patients with rhinitis not included in published references were obtained from Novartis Pharma AG (data on file at Novartis Pharma AG, Basel, Switzerland). ICS: inhaled corticosteroids; CAT: current asthma therapy. #: seasonal or persistent allergic rhinitis; ¶: persistent allergic rhinitis.