A review of anti-IgE monoclonal antibody (omalizumab) as add on therapy for severe allergic (IgE-mediated) asthma

Figures & data

Table 1 Biological characteristics of omalizumab

Omalizumab expresses a high degree of isotype specificity and can neutralize serum free IgE without affecting other antibody classes. Omalizumab binds to serum free IgE and reduces IgE serum concentration, but does not bind to high- or low-affinity IgE receptors on inflammatory cells. However, it blocks IgE binding to these receptors and the IgE effector cells of inflammation are “disarmed”. Long-term treatment (3 months or more) with omalizumab induced down-regulation of the high-affinity receptors on basophils and dendritic cells. Omalizumab does not induce extensive immune complex formation, but only microcomplexes (thrimeric or exameric) which are not able to induce immune-complex pathology. Omalizumab activity does not depend on the allergic-atopic sensitization to various types of aeroallergens (seasonal and/or perennial). Omalizumab is active in case of IgE-mediated sensitization to one or more aeroallergens.

Table 2 Omalizumab in clinical studies in allergic asthma patients

Omalizumab has been shown to:

Decrease IgE-induced bronchoconstriction during both the early- and late-phase responses to inhaled allergen during the bronchial provocation tests. Reduce skin prick test response to allergenic extracts. Reduce asthma exacerbations regardless of the type of seasonal or perennial allergic sensitization. Have a corticosteroid sparing effect. Reduce the use of bronchodilators. Improve also the nasal symptoms in subjects with allergic rhinitis associated with asthma. Improve quality of life in patients with asthma, and also in those with severe persistent allergic asthma that is inadequately controlled by currently available asthma medication. Have a reassuring safety profile similar to that of placebo. In malignant neoplasms observed in patients treated with omalizumab, blinded and unblended expert oncologist review showed that the neoplasms were most likely pre-existent and there was no evidence that any of neoplasms were linked causally to omalizumab treatment.

Table 3 Reduction in asthma exacerbation rates across studies

	Rate per year		P-Value for rate ratio	Exac. rate treatment difference
	Omalizumab	Control
INNOVATE study	1.37	1.86	0.042	0.49
ETOPA study1	0.98	2.47	<0.001	1.49
SOLAR study2	0.49	0.79	0.027	0.29
Busse study3,4	0.59	0.99	<0.001	0.40
Solèr study5,6	0.51	1.21	<0.001	0.70
Holgate study7	1.18	1.60	0.165	0.42
ALTO safety study	1.02	1.20	0.077	0.18
Pooled	0.91	1.47	<0.001	0.56

1 Ayres et al 2004

2 Vignola et al 2004

3 Busse et al 2001

4 Lanier et al 2003

5 Solèr et al 2001

6 Buhl et al 2002

7 Holgate et al 2004

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