Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE

BACKGROUND:
Patients with severe persistent asthma who are inadequately controlled despite
Global Initiative for Asthma (GINA) 2002 step 4 therapy are a challenging
population with significant unmet medical need. We determined the effect of
omalizumab on clinically significant asthma exacerbations (requiring systemic
corticosteroids) in the first omalizumab study to exclusively enrol patients from this
difficult-to-treat patient population.
METHODS:
Following a run-in phase, patients (12-75 years) inadequately controlled despite
therapy with high-dose inhaled corticosteroids (ICS) and long-acting beta(2)-
agonists (LABA) with reduced lung function and a recent history of clinically
significant exacerbations were randomized to receive omalizumab or placebo for 28
weeks in a double-blind, parallel-group, multicentre study.
RESULTS:
A total of 419 patients were included in the efficacy analyses. The clinically
significant asthma exacerbation rate (primary efficacy variable), adjusted for an
observed relevant imbalance in history of clinically significant asthma
exacerbations, was 0.68 with omalizumab and 0.91 with placebo (26% reduction)
during the 28-week treatment phase (P = 0.042). Without adjustment, a similar
magnitude of effect was seen (19% reduction), but this did not reach statistical
significance. Omalizumab significantly reduced severe asthma exacerbation rate
(0.24 vs 0.48, P = 0.002) and emergency visit rate (0.24 vs 0.43, P = 0.038).
Omalizumab significantly improved asthma-related quality of life, morning peak
expiratory flow and asthma symptom scores. The incidence of adverse events was
similar between treatment groups.
CONCLUSIONS:
In patients with inadequately controlled severe persistent asthma, despite highdose
ICS and LABA therapy, and often additional therapy, omalizumab significantly
reduced the rate of clinically significant asthma exacerbations, severe
exacerbations and emergency visits. Omalizumab is effective and should be
considered as add-on therapy for patients with inadequately controlled severe
persistent asthma who have a significant unmet need despite best available
therapy.