Xolair dosing

Omalizumab (Xolair) is an anti-IgE antibody approved for the treatment of allergic asthma not well controlled by oral or inhaled corticosteroids. The dosage is determined by the patient s baseline total serum IgE (international units/mL) and body weight (kg). Doses range from 150 to 375 mg given subcutaneously at either 2- or 4-week intervals. 

U.S. subjects were enrolled using a 1 1 randomization in a 7-month double-blind core study comprised of 16 weeks of stable treatment followed by 12 weeks of attempted steroid dose reduction (Fig. 1). Patients received Xolair based on body weight and the total serum IgE level at the first visit (Fig. 2). The primary efficacy variables were the number of asthma exacerbation episodes experienced by a patient during the steroid-reduction period and during the double-blind stabilization period. There were a number of secondary efficacy variables. The secondary efficacy variables measured for the double-blind stabilization period were number of patients experiencing at least one exacerbation and the number of puffs of rescue medication taken. Secondary efficacy variables for the double-blind steroid-... 

After 16 weeks of treatment, Xolair-treated patients were able to tolerate a significantly greater reduction in inhaled corticosteroid (ICS) dose than placebo... 

Results of the secondary efficacy variables (number of patients experiencing at least one asthma exacerbation, percent reduction in the dose of BDP, proportion of patients with reduction in BDP, number of puffs of rescue medication taken daily, and global evaluations of treatment effectiveness) were consistent with the Xolair superiority seen in the primary endpoint. Furthermore, consistency was also seen in the exploratory variables including PEFR, spirometry, and mean asthma symptom scores, with statistically significant differences shown in favor of anti-IgE for most variables. 

The reduction of inhaled corticosteroids (the median BDP dose decrease was 83% on Xolair versus 50% in placebo plus standard therapy patients)... 

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). 

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... 

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