• S T Holgate, A G Chuchalin, J Hébert, J Lötvall, G B Persson, K F Chung, J Bousquet, H A Kerstjens, H Fox, J Thirlwell, G Della Cioppa, and Omalizumab 011 International Study Group.
• RCMB Research Division, Southampton General Hospital, Southampton, UK. sth@soton.ac.uk
• Clin. Exp. Allergy. 2004 Apr 1;34(4):632-8.

BackgroundPatients with severe asthma are often inadequately controlled on existing anti-asthma therapy, constituting an unmet clinical need.ObjectiveThis randomized, double-blind, placebo-controlled trial evaluated the ability of omalizumab, a humanized monoclonal anti-IgE antibody, to improve disease control sufficiently to enable inhaled corticosteroid reduction in patients with severe allergic asthma.MethodsAfter a run-in period when an optimized fluticasone dose (> or =1000 microg/day) was received for 4 weeks, patients were randomized to receive subcutaneous omalizumab [minimum 0.016 mg/kg/IgE (IU/mL) per 4 weeks; n=126] or matching placebo (n=120) at intervals of 2 or 4 weeks. The study comprised a 16-week add-on phase of treatment followed by a 16-week fluticasone-reduction phase. Short-/long-acting beta(2)-agonists were allowed as needed.ResultsMedian reductions in fluticasone dose were significantly greater with omalizumab than placebo: 60% vs. 50% (P=0.003). Some 73.8% and 50.8% of patients, respectively, achieved a > or =50% dose reduction (P=0.001). Fluticasone dose reduction to < or =500 microg/day occurred in 60.3% of omalizumab recipients vs. 45.8% of placebo-treated patients (P=0.026). Through both phases, omalizumab reduced rescue medication requirements, improved asthma symptoms and asthma-related quality of life compared to placebo.ConclusionOmalizumab treatment improves asthma control in severely allergic asthmatics, reducing inhaled corticosteroid requirements without worsening of symptom control or increase in rescue medication use.

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