Xolair asthma

Omalizumab Humanized IgGlK CHO IgE Removes IgE Chronic asthma Xolair ... 

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. 

Xolair Qmalizumab Genentech, Novartis, and Tanox (Houston, TX), Anti-IgE AUergic asthma 2003... 

Others Osteoporosis, asthma, cystic fibrosis, acute myocardial infarction, severe sepsis, psoriasis, non-Hodgkin s lymphoma Forteo, Xolair, Puhnozyme, Activase/TNKase, Xigris, Raptiva, Zevahn... 

Omalizumab Xolair Asthma (positive skin test or in-vitro reactivity to a perennial aeroallergen) 2003 (not by EMEA)C)... 

Xolair Omalizumab Humanized IgGi IgE Asthma sc 150-375 mg B iweekly-monthly... 

Xolair omalizumab (2003) Anti-IgE (mAb-IgGl) Asthma Cynomolgus monkey (F, EFD)... 

Omalizumab Xolair Genentech Anti-IgE IgGl kappa Asthma 2003... 

Xolair Omalizumab Genentech 6/2003 Moderate to severe persistent asthma CHO... 

Omalizumab Xolair (Genentech/Novartis/Tanox Asthma... 

Xolair G enentech / N ova r t i s / Tanox Humanized 2003 IgE Allergic asthma... 

Omalizumab Xolair Genentech, Novartis humanized mAb IgE allergic asthma 2003 IgGl <0.1%... 

Omalizumab (Xolair) is the first biological drug approved for the treatment of asthma. Omalizumab is a recombinant humanized monoclonal antibody targeted against IgE. IgE bound to omalizumab cannot bind to IgE receptors on mast cells and basophils, thereby preventing the allergic reaction at a very early step in the process. 

Omalizumab Xolair Humanized IgE Allergic asthma Genentech... 

Respiratory Xolair First anti-immunoglobulin E (IgE) for asthma and rhinitis Novartis, Genentech, Tanox Inc. Leading... 

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-... 

The overall effectiveness of Xolair treatment was clearly reflected in measures of the asthma-related quality of life. Patient s self-assessment of asthma-related quality of life, using the validated asthma-related quality-of-life questionnaire (AQLQ) (16), showed a clinically significant change from baseline of 0.5 units improvement in both treatment groups for all domains at the end of both treatment stabilization and steroid-reduction periods. Importantly, a significantly greater improvement over placebo was seen in Xolair-treated patients for each of the individual domains (activities, emotions, symptoms, environmental exposure) and overall scores (p = 0.02). 

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. 

Nocturnal asthma symptoms (median score falling from 1.14 to 0.36 after 16 weeks of Xolair treatment, where a score of 1 represents a daily awakening due to asthma symptoms, compared to a change from 1.29 to 0.83... 

Importantly, the benefit of reduced asthma exacerbations seen in the Xolair group during the stabilization period continued during the steroid-reduction phase despite a significantly greater reduction of inhaled corticosteroid and less frequent use of rescue medication. The evidence of superior symptom control and respiratory function, which also continued throughout the steroid-reduction period, further enhances the confidence in these anti-IgE efficacy results. 

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). 

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