Respiratory medicine
-
Respiratory medicine · Oct 2008
Randomized Controlled Trial Multicenter StudyEffectiveness of omalizumab in patients with inadequately controlled severe persistent allergic asthma: an open-label study.
In a 1-year, randomized, open-label study in patients with moderate-to-severe allergic (immunoglobulin E (IgE)-mediated) asthma, adding omalizumab to best standard care (BSC) significantly improved efficacy outcomes compared with BSC alone (control). We assessed the efficacy of omalizumab in the subgroup of patients with inadequately controlled severe persistent allergic asthma despite high-dose inhaled corticosteroids (ICS) plus a long-acting beta(2)-agonist (LABA), which reflects the European Union (EU) label population. ⋯ Adding omalizumab to BSC is efficacious in patients with inadequately controlled severe persistent allergic asthma despite high-dose ICS plus a LABA (EU label population), with further efficacy observed in patients judged to have responded to therapy which may more accurately illustrate the actual benefit of omalizumab therapy in clinical practice. The naturalistic setting of this study confirms the benefits observed in double-blind randomized clinical trials.