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Recent News and Articles on the Keywords: exacerbation rate + risk patients + xolair  Related to the article below (Last Update: 7/8/2008)

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Source: Google News

[CITATION] Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are … -
M Humbert, R Beasley, J Ayres, R Slavin, J Hebert, … - Allergy, 2005 - Blackwell Synergy
... reduced the severe asthma exacerbation rate and the ... anti-immunoglobulin E antibody,
in patients with allergic ... Risk factors for asthma deaths: a population-based ...

[CITATION] … and tolerability of anti-immunoglobulin E therapy with omalizumab in patients with poorly controlled … -
JG Ayres, B Higgins, ER Chilvers, G Ayre, M Blogg, … - Allergy, 2004 - Blackwell Synergy
... The reduction in the asthma exacerbation rate with omalizumab ... the latter analysis,
the annualized rate of asthma ... with allergic asthma at high risk of serious ...

[CITATION] … antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent … -
J Bousquet, P Cabrera, N Berkman, R Buhl, S … - Allergy, 2005 - Blackwell Synergy
... and are at higher risk of exacerbation, hospitalization and even ... with a pronounced
reduction in the rate of asthma ... with allergic asthma at high risk of serious ...

… , reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma -
J Corren, T Casale, Y Deniz, M Ashby - The Journal of Allergy and Clinical Immunology, 2003 - Elsevier
... 9 The effect of omalizumab on exacerbation incidence was ... 100 patient-years on placebo
(relative risk [RR] = 0.60 ... Similarly, the incidence rate of emergency room ...

Anti-IgE antibodies for the treatment of asthma. -
R Buhl - Current Opinion in Pulmonary Medicine, 2005 - co-pulmonarymedicine.com
... Xolair is also approved in Australia. ... In a meta-analysis of high-risk patients,
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Anti-IgE therapy -
J Brownell, TB Casale - Immunol Allergy Clin North Am, 2004 - Elsevier
... outcome measure was the annualized rate of significant asthma exacerbation episodes,
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[PDF] Emerging Therapeutic Strategies for Asthma Management -
SD SULLIVAN, E MELTZER - Exploring New Frontiers in Asthma Management for Optimal … - amcp.org
... Omalizumab reduced the asth- ma exacerbation rate by 56% in the 254 high-risk
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Managing asthma during pregnancy -
MS Blaiss, C Theophylline, B Omalizumab Xolair - Postgrad Med, 2004 - postgradmed.com
... newborn may have jitteriness, increased heart rate, and even ... mother has an acute
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The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic … -
M Soler, J Matz, R Townley, R Buhl, JO'Brien, H … - European Respiratory Journal, 2001 - Eur Respiratory Soc
... increasingly induced investigators to choose exacerbation rate as the ... induce and
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Anti-IgE: lessons from clinical trials in patients with severe allergic asthma symptomatic despite …
R Buhl - European Respiratory Review, 2007 - Eur Respiratory Soc
... Table 2? Effect of omalizumab on exacerbation rates across ... The malignancy rate per
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Source: Google Scholar
 
 

Xolair halves rate of severe exacerbations in patients at risk of life-threatening asthma attacks

 
 
Results of a clinical study showed that Xolair ( Omalizumab ) halved the rate of severe asthma exacerbations and reduced the rate of hospital emergency visits by 44% in patients with inadequately controlled severe persistent asthma, who are at high risk of life-threatening attacks.

Xolair also significantly improved patients' asthma-related quality of life.

Xolair is a first-in-class therapy that is given by injection every two or four weeks and blocks the action of IgE, the antibody responsible for triggering the cascade of allergic symptoms in patients with diseases such as allergic asthma. It offers a novel therapeutic approach to the control of asthma symptoms such as wheezing and shortness of breath, even in the most difficult-to-treat patients whose condition remains poorly-controlled despite receiving the best available therapy.

A total of 419 such patients, aged 12-75, were recruited for a double-blind, placebo-controlled, parallel-group, multicenter study called INNOVATE to assess the effect of add-on Xolair therapy on the rate of severe asthma exacerbations and emergency visits.
The participants all had reduced lung function and a recent history of clinically significant exacerbations, despite receiving step 4 therapy as defined in the GINA guidelines, including high-dose inhaled corticosteroids, long-acting beta2-agonists and other controller medication (including oral corticosteroids) if required.

The severe exacerbation rate ( i.e. where lung function measured by PEF or FEV1 was less than 60% of personal best, requiring systemic corticosteroids ) and the rate of emergency visits ( i.e. hospital admissions, emergency room visits and unscheduled doctor's visits ) were calculated during the treatment phase.

Results showed that add-on Xolair therapy significantly reduced both the severe exacerbation rate ( 0.24 vs 0.48, p=0.002 ) and emergency visit rate ( 0.24 vs 0.43, p=0.038 ) compared with placebo.

The authors concluded: " Omalizumab should be considered as add-on therapy for patients with inadequately controlled severe persistent asthma who have a significant unmet need despite best available therapy ."

The rate of clinically significant asthma exacerbations ( i.e. those requiring rescue systemic corticosteroid therapy ) was significantly reduced by 26% ( p = 0.043 ), when adjusted for an observed imbalance in asthma exacerbation history prior to randomisation into the trial. Without taking this baseline imbalance into account, a similar magnitude of effect was seen ( i.e. a 19% reduction ) but this did not reach statistical significance.

A further analysis of data from the INNOVATE study evaluated the impact of Xolair treatment on patients' quality of life, measured by the Asthma QoL Questionnaire ( AQLQ ) ( i.e. individual domains, overall score and clinically meaningful =0.5-point improvement ).
Add-on Xolair therapy produced significantly greater improvements than placebo for each individual AQLQ domain ( p<0.002 ) and overall score ( p<0.001 ).
In addition, a significantly greater proportion of patients receiving Xolair achieved a clinically meaningful =0.5-point improvement from baseline in their AQLQ score than patients receiving placebo ( 60.8% vs 47.8%, p=0.008 ).

The percentage of patients who experienced adverse events ( Aes ) in the core trial was similar in the Xolair and placebo groups ( 89.3%, n=201 and 87.2%, n=95 respectively ).
Of the 309 patients who entered the 24-week extension of the core trial, 244 ( 79.0% ) experienced an AE.
A total of 188 patients continued into the three-year extension, of whom 103 completed the study. Of the 85 patients who discontinued, the majority withdrew consent due to study duration and maintaining study commitments.

Xolair was generally well-tolerated and most AEs were mild to moderate in severity. When evaluated by 28-week increments, the incidence of AEs was generally comparable or lower than that seen in the 28-week core trial.
No AEs suggestive of immunological reactions were reported. Overall, there were 13 AEs that investigators suspected were drug-related.
There were eight serious AEs of which only one ( dyspnea ) was considered to be drug-related. No evidence of clinically significant changes in vital signs, spirometry or laboratory parameters, including platelets, were observed following Xolair treatment.

Source: 101st International Conference of the American Thoracic Society ( ATS ), 2005
 
 
 
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