|
|
|
||||||||||
Drug Information Practice Resident, Department of Pharmacy, University of Virginia Health System, PO Box 800674, Charlottesville, VA 22908-0674, fax 434/982-1682, ld4z{at}virginia.edu
Reprints: Lorrie A Davis PharmD
OBJECTIVE: To review the pharmacology, efficacy, and safety of omalizumab, focusing on the treatment of allergic asthma.
DATA SOURCES: A MEDLINE search (1966November 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.
STUDY SELECTION AND DATA EXTRACTION: Clinical trials
evaluating the pharmacology, efficacy, and safety of omalizumab for treatment
of allergic asthma in patients aged
12 years were selected. Clinical
trials examining utility in pediatric patients were also reviewed.
DATA SYNTHESIS: 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.
Key Words: allergic asthma, omalizumab, Xolair
Published Online, June 8, 2004. www.theannals.com, DOI 10.1345/aph.1D626
THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE
UNIVERSAL PROGRAM NUMBER: 407-000-04-024-H01