EXTRA
Trial question
What is the effect of omalizumab in patients with severe allergic asthma that is inadequately controlled with standard therapy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
66.0% female
34.0% male
N = 848
848 patients (557 female, 291 male).
Inclusion criteria: patients with inadequately controlled severe asthma who are receiving high-dose ICS and LABAs, with or without additional controller therapy.
Key exclusion criteria: asthma exacerbation requiring intubation in the 12 months before screening or an exacerbation requiring treatment with systemic corticosteroids in the 30 days before screening, active lung disease other than asthma, treatment with omalizumab in the 12 months before screening, elevated serum IgE levels for reasons other than allergy, or smoking history of ≥ 10 pack-years.
Interventions
N=427 omalizumab (minimum dose of 0.008 mg/kg of body weight per IgE (IU/mL) every 2 weeks or 0.016 mg/kg per IgE (IU/mL) every 4 weeks for 48 weeks).
N=421 placebo (matching placebo for 48 weeks).
Primary outcome
Asthma exacerbations at 48 weeks
0.66 /pt
0.88 /pt
0.9/pt
0.7/pt
0.4/pt
0.2/pt
0.0/pt
Omalizumab
Placebo
Significant
decrease ▼
Significant decrease in asthma exacerbations at 48 weeks (0.66 per patient vs. 0.88 per patient; IRR 0.75, 95% CI 0.61 to 0.92).
Secondary outcomes
Significant increase in AQLQ[S] scores (1.15 points vs. 0.92 points; MD 0.23, 95% CI 0.07 to 0.39).
Significant decrease in Asthma Symptom Score (-1.56 points vs. -1.3 points; MD -0.26, 95% CI -0.49 to -0.1).
No significant difference in daily albuterol puffs (-1.58 puffs vs. -1.31 puffs; MD -0.28, 95% CI -0.6 to 0.04).
Safety outcomes
No significant difference in adverse events (80.4% vs. 79.5%) and serious adverse events (9.3% vs. 10.5%).
Conclusion
In patients with inadequately controlled severe asthma who are receiving high-dose ICS and LABAs, with or without additional controller therapy, omalizumab was superior to placebo with respect to asthma exacerbations at 48 weeks.
Reference
Hanania NA, Alpan O, Hamilos DL et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011 May 3;154(9):573-82.
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