NEWS HIGHLIGHTSMedia Articles Related to Xolair (Omalizumab)
FDA Investigating Safety of Asthma Drug Xolair
Source: MedicineNet Anaphylaxis Specialty [2009.07.17]
Title: FDA Investigating Safety of Asthma Drug Xolair
Category: Health News
Created: 7/17/2009 7:00:00 AM
Last Editorial Review: 7/17/2009
Xolair® improves rate of severe asthma exacerbations
Source: Doctors Lounge - Chest Diseases
Xolair reduced the rate of hospital emergency visits by 44% in patients with inadequately controlled asthma.
Asthma Combo Seems Less Influenced by Genes (HealthDay)
Source: Y! Health Asthma News [2009.11.19]
HealthDay - THURSDAY, Nov. 19 (HealthDay News) -- People's genetic makeup has
been shown to affect how they respond to asthma medications, but a new
study finds that many people respond well to a particular combination
treatment regardless of their genes.
Annals Of Allergy, Asthma And Immunology To Be Published By Elsevier
Source: Allergy News From Medical News Today [2009.11.18]
Elsevier is pleased to announce that beginning with Volume 104 (2010) it will assume publication of the Annals of Allergy, Asthma & Immunology, the official journal of the American College of Allergy, Asthma & Immunology (ACAAI). The i>Annals of Allergy, Asthma & Immunology, published since 1942, will continue under the leadership of Editor Gailen D. Marshall, MD, PhD and a distinguished editorial board.
Folic Acid Late in Pregnancy Tied to Asthma in Kids
Source: MedicineNet Asthma Specialty [2009.11.16]
Title: Folic Acid Late in Pregnancy Tied to Asthma in Kids
Category: Health News
Created: 11/13/2009 2:10:00 PM
Last Editorial Review: 11/16/2009
Published Studies Related to Xolair (Omalizumab)
Safety of anti-IgE treatment with omalizumab in children with seasonal allergic rhinitis undergoing specific immunotherapy simultaneously. [2009.09.02]
Kamin W, Kopp MV, Erdnuess F, Schauer U, Zielen S, Wahn U. Safety of anti-IgE treatment with omalizumab in children with seasonal allergic rhinitis undergoing specific immunotherapy simultaneously.
Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma. [2009.02]
BACKGROUND: The treatment of allergic asthma by specific immunotherapy (SIT) is hampered by potential side-effects. OBJECTIVE: The aim of this study was to study the effect of omalizumab, a monoclonal anti-IgE antibody, in combination with SIT in patients with seasonal allergic rhinoconjunctivitis (SAR) and co-morbid seasonal allergic asthma (SAA) incompletely controlled by conventional pharmacotherapy... CONCLUSION: Combination of omalizumab with SIT for treatment of patients with SAR and co-morbid SAA was safe and reduced the symptom load in a statistically significant and clinically meaningful manner.
Asthma symptom re-emergence after omalizumab withdrawal correlates well with increasing IgE and decreasing pharmacokinetic concentrations. [2009.01]
BACKGROUND: Physicians have questioned whether omalizumab can be discontinued or the dose reduced after clinical improvement is seen in patients with severe asthma. OBJECTIVES: To examine the relationships among omalizumab, free IgE, and clinical outcomes in a randomized, placebo-controlled trial in patients with severe persistent allergic asthma following a posology based on pretreatment total IgE and body weight... CONCLUSION: Omalizumab and free IgE correlated well with clinical symptoms. Reducing omalizumab doses below those in the dosing table cannot be recommended; the resulting increase in free IgE would cause a deterioration in asthma control.
Add-on omalizumab improves day-to-day symptoms in inadequately controlled severe persistent allergic asthma. [2008.05]
BACKGROUND: Omalizumab is efficacious in the treatment of moderate-to-severe and severe persistent allergic (immunoglobulin E-mediated) asthma, reducing exacerbations, emergency visits and improving quality of life (QoL). However, as exacerbations are relatively infrequent, assessment of efficacy on day-to-day symptoms is warranted. AIMS: To investigate the effect of add-on omalizumab on day-to-day symptoms, and how they correlate with QoL in severe persistent asthma... CONCLUSIONS: In patients with inadequately controlled severe persistent asthma, day-to-day symptoms correlate well with QoL. Add-on omalizumab significantly improves day-to-day symptoms compared with placebo. Further improvement in responders confirms the physician's assessment as a response measure.
Allergen skin tests and free IgE levels during reduction and cessation of omalizumab therapy. [2008.02]
BACKGROUND: The recombinant humanized anti-IgE antibody omalizumab rapidly reduces serum free IgE concentrations and alleviates allergic airway disease. It is not known whether stopping or reducing the dose of omalizumab maintains adequate suppression of free IgE levels and IgE-mediated mast cell activation. OBJECTIVE: To determine the effects of omalizumab on serum free IgE and immediate allergen skin test reactivity during initial therapy followed by treatment reduction and cessation... CONCLUSION: Omalizumab reduced serum free IgE and immediate skin test reactivity to allergen during initial, high-dose administration. These effects were not fully maintained during dose reduction and returned to baseline after cessation of chronic treatment.
Clinical Trials Related to Xolair (Omalizumab)
Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids [Completed]
In patients with at least moderate persistent allergic asthma controlled with inhaled
steroids, omalizumab (administered per US product label), when compared to placebo, will
provide the participants with significantly improved tolerability of specific allergen
immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).
Effect of Ozone on Airway Inflammation in Allergic Asthmatics Treated With Omalizumab [Terminated]
Ozone can cause acute airway inflammation in both asthmatics and normal volunteers. However,
in asthmatics ozone can cause episodes of worsening of asthma. We want to learn if chronic
allergic response, known as "IgE-induced airway inflammation" is what causes the increased
inflammation in response to ozone. To do this we will examine the response to ozone in a
group of asthmatics treated with omalizumab, a medicine available and approved for use in
people with asthma, or a placebo control. The placebo for this study is inert physiologic
saline ("salt water") which contains no omalizumab. Both the omalizumab and the placebo will
be administered as an injection under the skin. Omalizumab, also called Xolair, is a
humanized monoclonal antibody, which means that it originally was produced in mice, then
genetically engineered to look more like human than mouse antibody. Omalizumab inactivates
IgE, a protein our own immune systems make as part of allergic reactions. The purpose of this
study is to test the hypothesis that omalizumab, by blocking this aspect of allergic
reactions, will decrease the number of inflammatory cells in the airway after ozone
challenge. We also hypothesize that omalizumab will decrease the effects of ozone on changes
in lung function, mucociliary clearance (a measure of how quickly mucus clears form the
airway) and airway reactivity. Airway reactivity is a measure of how sensitive the airways
are to a medication used to diagnose asthma, called methacholine. We will examine these as
additional information we can learn during the course of the study. This is a blinded study,
meaning that neither you nor the researchers know if you get the active drug or placebo, but
that information can be obtained if needed. The placebo is an injection of inert
physiological saline ("salt water") which contains no omalizumab.
Safety and Efficacy Study of Omalizumab Given Prior to Immunotherapy [Completed]
In patients with at least moderate persistent allergic asthma controlled with inhaled
steroids, omalizumab(administered per US product label), when compared to placebo, will
provide the participants with significantly improved tolerability of specific allergen
immunotherapy (allergy shots) administered per a cluster schedule(rapid build up method).
A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma [Completed]
This is a continued access protocol to provide subjects who have completed Genentech, Inc.
Study Q2143g, Q2195g, or Q2461g or Novartis Pharmaceuticals Corporation Study CIGE025 0010E1
with continued Xolair treatment. Subject eligibility will be based on disease severity and
asthma deterioration upon withdrawal of Xolair treatment. Subjects whose last Xolair dose
was <9 months prior to screening visit will continue with the same Xolair dosing regimen that
they received in the previous Genentech or Novartis clinical study.
Effects of Anti-IgE Antibody Omalizumab on Patients With Chronic Sinusitis [Withdrawn]
We propose to study the effects of Xolair on patients with chronic sinusitis with or without
nasal polyps. Because of the similarities between the inflammatory processes found in
asthmas and rhinitis to those found in chronic sinusitis, we hypothesize that sinusitis
should respond to Xolair, just as asthma.
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