Study of Xolair Anti-IgE in Severe Asthma

For all randomized patients in the inhaled steroid subpopulation, percent reductions in fluticasone dose at the end of double-blind treatment (week 32) are summarized in Table 4. For the inhaled randomized patients subpopulation, there was a highly significant reduction in inhaled steroid dose at the end of the treatment phase in E25 patients compared to placebo p = 0.003). Additionally, the median percent reduction was greater for E25 patients compared to placebo patients in both the Q2 week and Q4 week dosing subgroups. The distribution of 

A protocol-deflned AEE was defined as a worsening of asthma (decreased a.m. PEFR, worsening symptom scores unresponsive to increased rescue med use) requiring treatment with new or increased doses of systemic oral corticosteroids. There was an increase in the number of placebo patients experiencing one or more AEE in the corticosteroid reduction phase compared to the stabilization phase. This increase was more marked in placebo patients (0.25 episodes/patient to 0.45) compared to Xolair-treated patients (0.23-0.27 AEE/patient, respectively) (Table 5). 

Other Efficacy Measures of Anti-IgE Treatment in Severe Asthmatics 

In the inhaled steroid subpopulation, secondary efficacy results were also in favor of Xolair, showing statistical significance versus placebo in lowering absolute steroid dose at the end of the treatment phase and improvements in rescue medication use, asthma symptoms, and lung function. Statistical significance was demonstrated in these parameters at a number of time points. Most of the secondary 

Clinically meaningful improvements in quality-of-life (QOL) domains were seen in more Xolair-treated patients compared to placebo patients at the end of the stabilization and reduction phases. The improvement in activities, emotions, symptoms, and overall domains at the end of the reduction phase was seen 

---