Table 1—

Studies of omalizumab in patients with asthma

First author [Ref.]PopulationPatients nTreatment groupsRhinitis at baseline n (%)Treatment duration weeksOutcome
Humbert [42]Severe allergic asthma419Omalizumab + ICSNot available28Clinically significant exacerbation rate/patient: omalizumab 0.68, placebo 0.91, p = 0.042
Placebo + ICSSevere exacerbation rate/patient: omalizumab 0.24, placebo 0.48, p = 0.002
Ayres [43]Moderate/severe allergic asthma312Omalizumab + CAT205 (66)#52Asthma deterioration incident rate·yr−1: omalizumab 4.92, control 9.76, p<0.001
CATExacerbations·patient·yr−1: omalizumab 1.12, control 2.86, p<0.001
Vignola [9]Moderate/severe asthma and persistent allergic rhinitis405Omalizumab + ICS405 (100)28Patients with exacerbations: omalizumab 21%, placebo 30%, p = 0.02
Placebo + ICS
Busse [44]Moderate/severe allergic asthma525Omalizumab + ICS518 (99)#28Exacerbations/patient in stable steroid phase (16 weeks): omalizumab 0.28, placebo 0.54, p = 0.006
Placebo + ICSExacerbations/patient in steroid reduction phase (12 weeks): omalizumab 0.39, placebo 0.66, p = 0.003
Lanier [45]Moderate/severe allergic asthma460Omalizumab + ICSNot available24-week extensionExacerbations/patient: omalizumab 0.60, placebo 0.83, p = 0.023
Placebo + ICS
Solèr [39]Moderate/severe allergic asthma546Omalizumab + ICS478 (88)#28Exacerbations/patient in stable steroid phase (16 weeks): omalizumab 0.28, placebo 0.66, p<0.001
Placebo + ICSExacerbations/patient in steroid reduction phase (12 weeks): omalizumab 0.36, placebo 0.75, p<0.001
Buhl [40]Moderate/severe allergic asthma483Omalizumab + ICSNot available24-week extensionExacerbations/patient: omalizumab 0.48, placebo 1.14, p<0.001
Placebo + ICS
Holgate [46]Severe allergic asthma246Omalizumab + ICS203 (83)#32Reduction in fluticasone dose: omalizumab 57%, placebo 43.3%, p = 0.003
Placebo + ICS
ALTO [47]Severe asthma1760Omalizumab + CAT1561 (89)#24Exacerbation 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.