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Efficacy and tolerability of anti‐immunoglobulin E therapy with omalizumab in patients with poorly controlled (moderate‐to‐severe) allergic asthma
Author(s) -
Ayres J. G.,
Higgins B.,
Chilvers E. R.,
Ayre G.,
Blogg M.,
Fox H.
Publication year - 2004
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/j.1398-9995.2004.00533.x
Subject(s) - omalizumab , medicine , tolerability , exacerbation , asthma , immunoglobulin e , gastroenterology , randomized controlled trial , adverse effect , antibody , immunology
Background: Patients with poorly controlled asthma have greater morbidity and mortality. This study evaluated the efficacy and tolerability of omalizumab in patients with poorly controlled, moderate‐to‐severe allergic asthma. Methods: This was a randomized, open‐label, multicentre, parallel‐group study. A total of 312 patients (12–73 years) receiving ≥400 μ g/day (adolescent) or ≥800 μ g/day (adult) inhaled beclomethasone dipropionate, or equivalent were included. Patients received best standard care (BSC) with or without omalizumab [at least 0.016 mg/kg/IgE (IU/ml) every 4 weeks] for 12 months. Results: The annualized mean number of asthma deterioration‐related incidents was reduced from 9.76 with BSC alone ( n = 106) to 4.92 per patient‐year with omalizumab ( n = 206) ( P < 0.001). Mean clinically significant asthma exacerbation rates were 2.86 and 1.12 per patient‐year, respectively ( P < 0.001). Omalizumab‐treated patients (41.4%) required rescue medication <1 day/week compared with 20.7% for BSC alone ( P < 0.001). Omalizumab improved absolute forced expiratory volume in 1 s (FEV 1 ) compared with BSC alone (2.48 and 2.28l, respectively; P < 0.05) and reduced symptom scores relative to BSC alone (decrease of 6.5 and 0.7 respectively; P < 0.001). Omalizumab was well‐tolerated. Conclusions: Omalizumab administered as add‐on therapy to BSC benefits patients with poorly controlled, moderate‐to‐severe allergic asthma.