Omalizumab in Severe Allergic Asthma Inadequately Controlled With Standard Therapy Full Text
Annals of Internal Medicine, 05/03/2011
Hanania NA et al. – In this study, omalizumab provided additional clinical benefit for patients with severe allergic asthma that is inadequately controlled with high–dose Inhaled corticosteroids (ICS) and long–acting (beta)2–agonist (LABA) therapy.Methods
- Prospective, multicenter, randomized, parallel–group, double–blind, placebo–controlled trial.
- 193 investigational sites in the United States and 4 sites in Canada.
- 850 patients aged 12 to 75 years who had inadequately controlled asthma despite treatment with high–dose ICS plus LABAs, with or without other controllers.
- Omalizumab (n = 427) or placebo (n = 423) was added to existing medication regimens for 48 weeks.
- The primary end point was the rate of protocol–defined exacerbations over the study period.
- Secondary efficacy end points included the change from baseline to week 48 in mean daily number of puffs of albuterol, mean total asthma symptom score, and mean overall score on the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]).
- Safety end points included the frequency and severity of treatment–emergent adverse events.
- During 48 weeks, the rate of protocol–defined asthma exacerbations was significantly reduced for omalizumab compared with placebo (0.66 vs. 0.88 per patient; P = 0.006), representing a 25% relative reduction (incidence rate ratio, 0.75 [95% CI, 0.61 to 0.92]).
- Omalizumab improved mean AQLQ(S) scores (0.29 point [CI, 0.15 to 0.43]), reduced mean daily albuterol puffs (–0.27 puff/d [CI, –0.49 to –0.04 puff/d]), and decreased mean asthma symptom score (–0.26 [CI, –0.42 to –0.10]) compared with placebo during the 48–week study period.
- The incidence of adverse events (80.4% vs. 79.5%) and serious adverse events (9.3% vs. 10.5%) were similar in the omalizumab and placebo groups, respectively.