Omalizumab: a novel therapy for allergic asthma.
OBJECTIVE
To review the pharmacology, efficacy, and safety of omalizumab, focusing on the treatment of allergic asthma.


METHODS
A MEDLINE search (1966-November 2003) was conducted using the key words omalizumab, Xolair, and Rhu-MAB25, with studies limited to those in humans and published in English. References of identified articles were reviewed for additional citations.


METHODS
Clinical trials evaluating the pharmacology, efficacy, and safety of omalizumab for treatment of allergic asthma in patients aged >or=12 years were selected. Clinical trials examining utility in pediatric patients were also reviewed.


RESULTS
Omalizumab's ability to form complexes with unbound immunoglobulin E (IgE) translates into decreased unbound serum IgE levels and high-affinity IgE receptors on basophils, as well as attenuation of early and late allergic response in patients with allergic asthma. Results of clinical trials demonstrated that omalizumab administered subcutaneously is a safe and effective treatment for moderate to severe allergic asthma. Generally, omalizumab has a mild adverse effect profile. Omalizumab may be particularly useful for treatment of moderate to severe allergic asthma in patients who are poorly controlled on conventional therapy, experience adverse effects secondary to high-dose or prolonged corticosteroid treatment, or who have frequent exacerbations because of poor medication adherence. The high cost associated with omalizumab treatment may be prohibitive for some patients, thereby limiting its utility.


CONCLUSIONS
Omalizumab is a safe and effective therapy for treatment of moderate to severe allergic asthma in difficult-to-treat, high-risk patients.
Davis
Lorrie A
LA
Department of Pharmacy, University of Virginia Health System, PO Box 800674, Charlottesville, VA 22908-0674, USA. ld4z@virginia.edu
D018926:Anti-Allergic Agents / Q000191:economics / Q000494:pharmacology / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000191:economics / Q000494:pharmacology / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D006801:Humans; D000069444:Omalizumab; D011788:Quality of Life
D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab