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Article ; Online: Omalizumab: a recombinant humanized monoclonal IgE-blocking antibody.

Scheinfeld, Noah

2005 Volume 11, Issue 1, Page(s) 2

Abstract: Omalizumab (Xolair) is a recombinant humanized monoclonal antibody that blocks the high-affinity ... dosage is determined by body weight and pretreatment serum total IgE levels. Omalizumab may have a role ... Fc receptor of immunoglobulin E (IgE). It is used to treat patients with moderate-persistent to severe ...

Abstract	Omalizumab (Xolair) is a recombinant humanized monoclonal antibody that blocks the high-affinity Fc receptor of immunoglobulin E (IgE). It is used to treat patients with moderate-persistent to severe-persistent asthma; patients must be older than 12 years, have a positive skin test to a perennial aeroallergen (e.g., dust mites, cats, dogs, and mold), and be symptomatic with inhaled corticosteroids. Omalizumab has a low incidence of side effects, and it is very expensive. The exact dosage of omalizumab dosage is determined by body weight and pretreatment serum total IgE levels. Omalizumab may have a role in the treatment of atopic dermatitis when IgE plays a causal role.
MeSH term(s)	Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal/immunology ; Antibodies, Monoclonal/pharmacology ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Clinical Trials as Topic ; Dermatitis, Atopic/drug therapy ; Dermatologic Agents/immunology ; Dermatologic Agents/pharmacology ; Dermatologic Agents/therapeutic use ; Humans ; Immunoglobulin E/drug effects ; Interleukins/immunology ; Omalizumab
Chemical Substances	Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Dermatologic Agents ; Interleukins ; Omalizumab (2P471X1Z11) ; Immunoglobulin E (37341-29-0)
Language	English
Publishing date	2005-03-01
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2026239-5
ISSN	1087-2108 ; 1087-2108
ISSN (online)	1087-2108
ISSN	1087-2108
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Omalizumab for treatment of allergic rhinitis.

Vashisht, Priyanka / Casale, Thomas

Expert opinion on biological therapy

2013 Volume 13, Issue 6, Page(s) 933–945

Abstract: ... allergen immunotherapy. Removal of circulating free IgE by the recombinant humanized monoclonal anti-IgE antibody ... of IgE at the site of FcϵR1 binding, thus blocking binding of IgE to effector cells. We review ... Introduction: Immunoglobulin E (IgE) is a key pathogenic factor of allergic rhinitis, a prevalent ...

Abstract	Introduction: Immunoglobulin E (IgE) is a key pathogenic factor of allergic rhinitis, a prevalent disease adversely affecting quality of life and productivity. Areas covered: Binding of inhaled allergens to IgE on the surface of basophils and mast cells, with subsequent cross-linkage of IgE and aggregation of high-affinity receptors for IgE (FcϵRI), triggers the release of inflammatory mediators, followed by the onset of allergic rhinitis symptoms. Current therapeutic strategies include corticosteroids, mast cell stabilizers, leukotriene receptor antagonists, anticholinergics, antihistamines and allergen immunotherapy. Removal of circulating free IgE by the recombinant humanized monoclonal anti-IgE antibody, omalizumab (Xolair), represents a novel therapeutic approach. Omalizumab selectively binds to the Cϵ3 domain of IgE at the site of FcϵR1 binding, thus blocking binding of IgE to effector cells. We review omalizumab's clinical efficacy, administration, use with immunotherapy and safety in allergic rhinitis. Expert opinion: Omalizumab may provide a new treatment strategy for allergic rhinitis. The high cost of omalizumab precludes its chronic use for allergic rhinitis and it is not FDA approved for this indication; however, its periodic use may be justified in treatment resistant patients, especially those with seasonal disease.
MeSH term(s)	Animals ; Anti-Allergic Agents/administration & dosage ; Anti-Allergic Agents/adverse effects ; Anti-Allergic Agents/therapeutic use ; Antibodies, Anti-Idiotypic/administration & dosage ; Antibodies, Anti-Idiotypic/adverse effects ; Antibodies, Anti-Idiotypic/therapeutic use ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Humans ; Omalizumab ; Rhinitis, Allergic ; Rhinitis, Allergic, Perennial/diagnosis ; Rhinitis, Allergic, Perennial/drug therapy ; Rhinitis, Allergic, Perennial/immunology ; Rhinitis, Allergic, Seasonal/diagnosis ; Rhinitis, Allergic, Seasonal/drug therapy ; Rhinitis, Allergic, Seasonal/immunology ; Treatment Outcome
Chemical Substances	Anti-Allergic Agents ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal, Humanized ; Omalizumab (2P471X1Z11)
Language	English
Publishing date	2013-06
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2052501-1
ISSN	1744-7682 ; 1471-2598
ISSN (online)	1744-7682
ISSN	1471-2598
DOI	10.1517/14712598.2013.795943
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Article: Treating severe allergic asthma with anti-IgE monoclonal antibody (omalizumab): a review.

D'Amato, Gennaro / Stanziola, Anna / Sanduzzi, Alessandro / Liccardi, Gennaro / Salzillo, Antonello / Vitale, Carolina / Molino, Antonio / Vatrella, Alessandro / D'Amato, Maria

Multidisciplinary respiratory medicine

2014 Volume 9, Issue 1, Page(s) 23

Abstract: ... recombinant monoclonal anti-IgE antibody developed for the treatment of allergic diseases and with clear ... account for about 50% of the healthcare costs of asthma. Omalizumab is a biological engineered, humanized ... levels and IgE receptor expression on inflammatory cells in the context of allergic cascade, omalizumab ...

Abstract	Increased asthma severity is not only associated with enhanced recurrent hospitalization and mortality but also with higher social costs. Several cases of asthma are atopic in nature, with the trigger for acute asthma attacks and chronic worsening of inflammation being allergens inducing an immune, IgE mediated response. Anti-inflammatory treatments are effective for most of asthma patients, but there are subjects whose disease is incompletely controlled by inhaled or systemic corticosteroids and these patients account for about 50% of the healthcare costs of asthma. Omalizumab is a biological engineered, humanized recombinant monoclonal anti-IgE antibody developed for the treatment of allergic diseases and with clear efficacy in adolescent and adult patients with severe allergic asthma. The anti-IgE antibody inhibits IgE functions blocking free serum IgE and inhibiting their binding to cellular receptors. By reducing serum IgE levels and IgE receptor expression on inflammatory cells in the context of allergic cascade, omalizumab has demonstrated to be a very useful treatment of atopic asthma, improving quality of life of patients with severe persistent allergic asthma that is inadequately controlled by currently available asthma medications. Several trials have demonstrated that this therapy is well tolerated and significantly improves symptoms and disease control, reducing asthma exacerbations and the need to use high dosage of inhaled corticosteroids.
Language	English
Publishing date	2014-04-15
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2677839-7
ISSN	2049-6958 ; 1828-695X
ISSN (online)	2049-6958
ISSN	1828-695X
DOI	10.1186/2049-6958-9-23
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Article: Treating moderate-to-severe allergic asthma with anti-IgE monoclonal antibody (omalizumab). An update.

D'Amato, G / Perticone, M / Bucchioni, E / Salzillo, A / D'Amato, M / Liccardi, G

European annals of allergy and clinical immunology

2010 Volume 42, Issue 4, Page(s) 135–140

Abstract: ... these patients account for about 50% of the healthcare costs of asthma. Omalizumab is a humanized recombinant ... monoclonal anti-IgE antibody developed for the treatment of allergic diseases and with clear efficacy ... levels and IgE receptor expression on inflammatory cells in the context of allergic cascade, omalizumab ...

Abstract	Increased asthma severity is not only associated with enhanced recurrent hospitalisation and mortality but also with higher social costs. Most cases of asthma are atopic in nature, with the trigger for acute asthma attacks and chronic worsening of inflammation being allergens inducing an immune response through immunoglobulins of IgE class. Currently antiinflammatory treatments are effective for most of asthma patients, but there are subjects whose disease is incompletely controlled by inhaled or systemic corticosteroids and these patients account for about 50% of the healthcare costs of asthma. Omalizumab is a humanized recombinant monoclonal anti-IgE antibody developed for the treatment of allergic diseases and with clear efficacy in adolescent and adult patients with moderate-to-severe allergic asthma.. The anti-IgE antibody inhibits IgE functions blocking free serum IgE and inhibiting their binding to cellular receptors. By reducing serum IgE levels and IgE receptor expression on inflammatory cells in the context of allergic cascade, omalizumab represents a really new approach to the treatment of atopic asthma. Omalizumab improves quality of life of patients with severe persistent allergic asthma that is inadequately controlled by currently available asthma medications. This therapy is well tolerated and significantly improves symptoms, disease control, reducing asthma exacerbations and the need to use high dosage of inhaled corticosteroids. In other words, omalizumab may fulfil an important need in patients with moderate-to-severe asthma.
MeSH term(s)	Adolescent ; Adult ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal/immunology ; Antibodies, Monoclonal/metabolism ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Asthma/drug therapy ; Asthma/economics ; Asthma/immunology ; Asthma/physiopathology ; Disease Progression ; Health Care Costs ; Humans ; Immunoglobulin E/immunology ; Immunotherapy/trends ; Omalizumab ; Quality of Life
Chemical Substances	Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Omalizumab (2P471X1Z11) ; Immunoglobulin E (37341-29-0)
Language	English
Publishing date	2010-08
Publishing country	Italy
Document type	Journal Article ; Review
ZDB-ID	2105540-3
ISSN	1764-1489 ; 0397-9148
ISSN	1764-1489 ; 0397-9148
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Article: A recombinant humanized anti-IgE monoclonal antibody (omalizumab) in the therapy of moderate-to-severe allergic asthma.

D'Amato, Gennaro / Piccolo, Amedeo / Salzillo, Antonello / Noschese, Paolo / D'Amato, Maria / Liccardi, Gennaro

Recent patents on inflammation & allergy drug discovery

2008 Volume 1, Issue 3, Page(s) 225–231

Abstract: ... interesting options for asthma treatment and their patents. Omalizumab is a humanized recombinant monoclonal ... antibody inhibits IgE functions blocking free serum IgE and inhibiting their binding to cellular receptors ... anti-IgE antibody developed for the treatment of allergic diseases and with clear efficacy ...

Abstract	The pathogenetic aspect of allergic bronchial asthma is characterized by airway inflammation with infiltration of mast cells, basophils, eosinophils, monocytes and T-helper (Th)2 lymphocytes. Most cases of asthma are atopic in nature and aeroallergens such as those released by pollens, Dermatophagoides, moulds etc, act as sensitizer and trigger agents which induce immune response through immunoglobulin E (IgE). IgE is the key mediator of allergic inflammatory reaction and plays a central role in the pathogenesis of atopic-allergic diseases such as those of respiratory tract: rhinitis and bronchial asthma. Currently antiinflammatory and bronchodilation treatments, with integration of other drugs such as antileucotrienes, are effective for most of asthma patients, but there are asthmatic subjects whose disease is incompletely controlled by inhaled or systemic corticosteroids and these patients account for about 50% of the healthcare costs of asthma. A novel therapeutic approach to asthma and other allergic respiratory diseases involves interference in the action of IgE and IgE has been viewed as a target for novel immunological drug development in asthma. Monoclonal antibodies are a molecule able to interact with specific antigens and represent a very interesting options for asthma treatment and their patents. Omalizumab is a humanized recombinant monoclonal anti-IgE antibody developed for the treatment of allergic diseases and with clear efficacy in adolescent and adult patients with moderate-to-severe allergic asthma. This non-anaphylactogen anti-IgE antibody inhibits IgE functions blocking free serum IgE and inhibiting their binding to cellular receptors. By reducing serum IgE levels and IgE receptor expression on inflammatory cells in the context of allergic cascade. Omalizumab therapy is well tolerated and significantly improves symptoms, reducing asthma exacerbations and the need to use high dosage of inhaled corticosteroids to control disease. Moreover, omalizumab improves quality of life of patients with severe persistent allergic asthma that is inadequately controlled by currently available asthma medications. In conclusion omalizumab represents a really new approach to the treatment of atopic asthma and may fulfil an important need in patients with moderate-to-severe asthma.
MeSH term(s)	Animals ; Anti-Allergic Agents/adverse effects ; Anti-Allergic Agents/therapeutic use ; Anti-Asthmatic Agents/adverse effects ; Anti-Asthmatic Agents/therapeutic use ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Asthma/drug therapy ; Asthma/immunology ; Clinical Trials as Topic ; Humans ; Immunoglobulin E/immunology ; Omalizumab ; Patents as Topic ; Severity of Illness Index ; Treatment Outcome
Chemical Substances	Anti-Allergic Agents ; Anti-Asthmatic Agents ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Omalizumab (2P471X1Z11) ; Immunoglobulin E (37341-29-0)
Language	English
Publishing date	2008-08-19
Publishing country	United Arab Emirates
Document type	Journal Article ; Review
ISSN	1872-213X
ISSN	1872-213X
DOI	10.2174/187221307782418900
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Article: A review of anti-IgE monoclonal antibody (omalizumab) as add on therapy for severe allergic (IgE-mediated) asthma.

D'Amato, Gennaro / Salzillo, Antonello / Piccolo, Amedeo / D'Amato, Maria / Liccardi, Gennaro

Therapeutics and clinical risk management

2008 Volume 3, Issue 4, Page(s) 613–619

Abstract: ... a humanized recombinant monoclonal anti-IgE antibody approved for treatment of moderate to severe IgE-mediated ... allergic) asthma. This non-anaphylactogenic anti-IgE antibody inhibits IgE functions, blocking free serum ... this antibody has been viewed as a target for novel immunological drug development in asthma. Omalizumab is ...

Abstract	Bronchial asthma is recognized as a highly prevalent health problem in the developed and developing world with significant social and economic consequences. Increased asthma severity is not only associated with enhanced recurrent hospitalization and mortality but also with higher social costs. The pathogenetic background of allergic-atopic bronchial asthma is characterized by airway inflammation with infiltration of several cells (mast cells, basophils, eosinophils, monocytes, and T-helper (Th)2 lymphocytes). However, in atopic asthma the trigger factors for acute attacks and chronic worsening of bronchial inflammation are aeroallergens released by pollens, dermatophagoides, and pets, which are able to induce an immune response by interaction with IgE antibodies. Currently anti-inflammatory treatments are effective for most asthma patients, but there are asthmatic subjects whose disease is not completely controlled by inhaled or systemic corticosteroids and who account for a significant portion of the healthcare costs of asthma. A novel therapeutic approach to asthma and other allergic respiratory diseases involves interference in the action of IgE, and this antibody has been viewed as a target for novel immunological drug development in asthma. Omalizumab is a humanized recombinant monoclonal anti-IgE antibody approved for treatment of moderate to severe IgE-mediated (allergic) asthma. This non-anaphylactogenic anti-IgE antibody inhibits IgE functions, blocking free serum IgE and inhibiting their binding to cellular receptors. By reducing serum IgE levels and IgE receptor expression on inflammatory cells in the context of allergic cascade, omalizumab represents a new class of mast cells stabilizing drugs; it is a novel approach to the treatment of atopic asthma. Omalizumab therapy is well tolerated and significantly improves symptoms and disease control, reducing asthma exacerbations and the need to use high dosage of inhaled corticosteroids. Moreover, omalizumab improves quality of life of patients with severe persistent allergic asthma which is inadequately controlled by currently available asthma medications. In conclusion omalizumab may fulfil an important need in patients with moderate to severe asthma.
Language	English
Publishing date	2008-06-24
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2186560-7
ISSN	1178-203X ; 1176-6336
ISSN (online)	1178-203X
ISSN	1176-6336
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Article: Effect of omalizumab on symptoms of seasonal allergic rhinitis: a randomized controlled trial.

Casale, T B / Condemi, J / LaForce, C / Nayak, A / Rowe, M / Watrous, M / McAlary, M / Fowler-Taylor, A / Racine, A / Gupta, N / Fick, R / Della Cioppa, G

JAMA

2001 Volume 286, Issue 23, Page(s) 2956–2967

Abstract: ... symptoms. A recombinant humanized monoclonal anti-IgE antibody (omalizumab) forms complexes with free IgE ... and placebo groups.: Conclusion: Omalizumab decreased serum free IgE levels and provided clinical ... blocking its interaction with mast cells and basophils and lowering free IgE levels in the circulation ...

Abstract	Context: Seasonal allergic rhinitis is a common IgE-mediated disorder that produces troublesome symptoms. A recombinant humanized monoclonal anti-IgE antibody (omalizumab) forms complexes with free IgE, blocking its interaction with mast cells and basophils and lowering free IgE levels in the circulation. Objective: To assess the efficacy and safety of omalizumab for prophylaxis of symptoms in patients with seasonal allergic rhinitis. Design: Randomized, double-blind, dose-ranging, placebo-controlled trial conducted from July 25 through November 21, 1997. Setting: Twenty-five outpatient centers throughout the United States. Patients: Five hundred thirty-six patients aged 12 to 75 years with at least a 2-year history of moderate to severe ragweed-induced seasonal allergic rhinitis and a baseline IgE level between 30 and 700 IU/mL. Interventions: Patients were randomly assigned to receive omalizumab, 50 mg (n = 137), 150 mg (n = 134), or 300 mg (n = 129), or placebo (n = 136) subcutaneously just prior to ragweed season and repeated during the pollen season every 3 weeks in patients with baseline IgE levels of 151 to 700 IU/mL (4 total treatments) and every 4 weeks in patients with baseline IgE levels of 30 to 150 IU/mL (3 total treatments). Main outcome measures: Self-assessed daily nasal symptom severity scores (range, 0-3), rescue antihistamine use, and rhinitis-specific quality of life during the 12 weeks from the start of treatment. Results: Nasal symptom severity scores were significantly lower in patients who received 300 mg of omalizumab than in those who received placebo (least squares means, 0.75 vs 0.98, respectively; P =.002). A significant association was observed between IgE reduction and nasal symptoms and rescue antihistamine use. Rhinitis-specific quality of life scores were consistently better in patients who received 300 mg of omalizumab than in those who received lower dosages or placebo and did not decline during peak season. The frequency of adverse events was not significantly different among the omalizumab and placebo groups. Conclusion: Omalizumab decreased serum free IgE levels and provided clinical benefit in a dose-dependent fashion in patients with seasonal allergic rhinitis.
MeSH term(s)	Adolescent ; Adult ; Aged ; Anti-Allergic Agents/administration & dosage ; Anti-Allergic Agents/adverse effects ; Anti-Allergic Agents/therapeutic use ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Double-Blind Method ; Drug Administration Schedule ; Female ; Humans ; Immunoglobulin E/blood ; Male ; Middle Aged ; Omalizumab ; Quality of Life ; Rhinitis, Allergic, Seasonal/drug therapy ; Rhinitis, Allergic, Seasonal/immunology ; Rhinitis, Allergic, Seasonal/prevention & control
Chemical Substances	Anti-Allergic Agents ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Omalizumab (2P471X1Z11) ; Immunoglobulin E (37341-29-0)
Language	English
Publishing date	2001-12-07
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2958-0
ISSN	1538-3598 ; 0098-7484 ; 0254-9077 ; 0002-9955
ISSN (online)	1538-3598
ISSN	0098-7484 ; 0254-9077 ; 0002-9955
DOI	10.1001/jama.286.23.2956
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Article: Treating Moderate-to-Severe Allergic Asthma with a Recombinant Humanized Anti-IgE Monoclonal Antibody (Omalizumab).

D'Amato, Gennaro / Bucchioni, Enrica / Oldani, Virginio / Canonica, Walter

Treatments in respiratory medicine

2006 Volume 5, Issue 6, Page(s) 393–398

Abstract: ... mediated responses.Omalizumab is a humanized recombinant monoclonal anti-IgE antibody developed ... allergic asthma. This non-anaphylactogenic anti-IgE antibody inhibits IgE functions by blocking free serum ... IgE and inhibiting their binding to cellular receptors. Omalizumab therapy is well tolerated and ...

Abstract	Bronchial asthma is a chronic inflammatory disease of the airways which is recognized as a highly prevalent health problem in both the developed and the developing world, with significant human and economic consequences.Allergy is acknowledged as a major risk factor for asthma. The pathogenetic aspects of allergic asthma are characterized by airway inflammation with infiltration of mast cells, basophils, eosinophils, monocytes and T helper type 2 lymphocytes, along with the isotype switching of B cells to generate immunoglobulins of the immunoglobulin E (IgE) class. Increased asthma severity is not only associated with recurrent hospitalization and increased mortality but also with higher social costs.Inhaled corticosteroids are the standard anti-inflammatory medication and are effective for most asthma patients, but there is a substantial number of asthmatics who remain symptomatic even after receiving treatment with inhaled corticosteroids and long-acting beta(2)-adrenoceptor agonists (beta(2)-agonists), and sometimes are in need of systemic corticosteroids to control the disease. These patients account for about 50% of the healthcare costs of asthma.New treatment options more specifically targeting the pathophysiologic events causing development of asthma are therefore required in these patients.A novel therapeutic approach to asthma and other allergic respiratory diseases involves interference with the action of IgE and prevention of subsequent IgE-mediated responses.Omalizumab is a humanized recombinant monoclonal anti-IgE antibody developed for the treatment of allergic diseases, with clear efficacy in adolescent and adult patients with moderate-to-severe allergic asthma. This non-anaphylactogenic anti-IgE antibody inhibits IgE functions by blocking free serum IgE and inhibiting their binding to cellular receptors. Omalizumab therapy is well tolerated and significantly improves symptoms and disease control, and reduces asthma exacerbations and the need to use high dosages of inhaled corticosteroids. Moreover, omalizumab improves quality of life of patients with severe persistent allergic asthma that is inadequately controlled by currently available asthma medications. In conclusion, omalizumab may fulfill an important need in patients with moderate-to-severe asthma inadequately controlled with inhaled corticosteroids +beta(2)-agonists.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal, Humanized/therapeutic use ; Asthma/drug therapy ; Humans ; Omalizumab ; Quality of Life
Chemical Substances	Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Omalizumab (2P471X1Z11)
Language	English
Publishing date	2006-11-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	2151154-8
ISSN	2230-6102 ; 1176-3450
ISSN (online)	2230-6102
ISSN	1176-3450
DOI	10.2165/00151829-200605060-00004
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Article: Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma.

Busse, W / Corren, J / Lanier, B Q / McAlary, M / Fowler-Taylor, A / Cioppa, G D / van As, A / Gupta, N

The Journal of allergy and clinical immunology

2001 Volume 108, Issue 2, Page(s) 184–190

Abstract: Background: A recombinant humanized anti-IgE mAb, omalizumab, forms complexes with free IgE ... depending on baseline IgE level and body weight. Inhaled corticosteroid doses were kept stable over ... of omalizumab in the treatment of inhaled corticosteroid-dependent asthma.: Methods: In this phase III ...

Abstract	Background: A recombinant humanized anti-IgE mAb, omalizumab, forms complexes with free IgE, blocking its interaction with mast cells and basophils; as a consequence, it might be effective in the treatment of asthma. Objective: The purpose of this study was to evaluate the efficacy and safety of omalizumab in the treatment of inhaled corticosteroid-dependent asthma. Methods: In this phase III, double-blinded, placebo-controlled trial, 525 subjects with severe allergic asthma requiring daily inhaled corticosteroids were randomized to receive placebo or omalizumab subcutaneously every 2 or 4 weeks, depending on baseline IgE level and body weight. Inhaled corticosteroid doses were kept stable over the initial 16 weeks of treatment and tapered during a further 12-week treatment period. Results: Omalizumab treatment resulted in significantly fewer asthma exacerbations per subject and in lower percentages of subjects experiencing an exacerbation than placebo treatment during the stable steroid phase (0.28 vs 0.54 [P =.006] and 14.6% vs 23.3% [P =.009], respectively) and during the steroid reduction phase (0.39 vs 0.66 [P =.003] and 21.3% vs 32.3% [P =.004], respectively). Beclomethasone dipropionate reduction was significantly greater with omalizumab treatment than with placebo (median 75% vs 50% [P <.001]), and beclomethasone dipropionate discontinuation was more likely with omalizumab (39.6% vs 19.1% [P <.001]). Improvements in asthma symptoms and pulmonary function occurred along with a reduction in rescue beta-agonist use. Omalizumab was well tolerated, with an adverse-events profile similar to that of placebo. Conclusion: The addition of omalizumab to standard asthma therapy reduces asthma exacerbations and decreases inhaled corticosteroid and rescue medication use.
MeSH term(s)	Adolescent ; Adult ; Aged ; Anti-Allergic Agents/adverse effects ; Anti-Allergic Agents/therapeutic use ; Anti-Asthmatic Agents/adverse effects ; Anti-Asthmatic Agents/therapeutic use ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized ; Asthma/drug therapy ; Child ; Female ; Humans ; Immunoglobulin E/blood ; Immunoglobulin E/immunology ; Male ; Middle Aged ; Omalizumab ; Respiratory Function Tests
Chemical Substances	Anti-Allergic Agents ; Anti-Asthmatic Agents ; Antibodies, Anti-Idiotypic ; Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Omalizumab (2P471X1Z11) ; Immunoglobulin E (37341-29-0)
Language	English
Publishing date	2001-08
Publishing country	United States
Document type	Clinical Trial ; Controlled Clinical Trial ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	121011-7
ISSN	1085-8725 ; 1097-6825 ; 0091-6749
ISSN (online)	1085-8725 ; 1097-6825
ISSN	0091-6749
DOI	10.1067/mai.2001.117880
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