PMID- 15187202 OWN - NLM STAT- MEDLINE DCOM- 20041006 LR - 20151119 IS - 1060-0280 (Print) IS - 1060-0280 (Linking) VI - 38 IP - 7-8 DP - 2004 Jul-Aug TI - Omalizumab: a novel therapy for allergic asthma. PG - 1236-42 AB - OBJECTIVE: To review the pharmacology, efficacy, and safety of omalizumab, focusing on the treatment of allergic asthma. DATA SOURCES: 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. STUDY SELECTION AND DATA EXTRACTION: 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. 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. FAU - Davis, Lorrie A AU - Davis LA AD - Department of Pharmacy, University of Virginia Health System, PO Box 800674, Charlottesville, VA 22908-0674, USA. ld4z@virginia.edu LA - eng PT - Journal Article PT - Review DEP - 20040608 PL - United States TA - Ann Pharmacother JT - The Annals of pharmacotherapy JID - 9203131 RN - 0 (Anti-Allergic Agents) RN - 0 (Antibodies, Anti-Idiotypic) RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 2P471X1Z11 (Omalizumab) SB - IM MH - Anti-Allergic Agents/economics/pharmacology/*therapeutic use MH - Antibodies, Anti-Idiotypic MH - Antibodies, Monoclonal/economics/pharmacology/*therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Asthma/*drug therapy MH - Clinical Trials as Topic MH - Humans MH - Omalizumab MH - Quality of Life RF - 23 EDAT- 2004/06/10 05:00 MHDA- 2004/10/07 09:00 CRDT- 2004/06/10 05:00 PHST- 2004/06/10 05:00 [pubmed] PHST- 2004/10/07 09:00 [medline] PHST- 2004/06/10 05:00 [entrez] AID - aph.1D626 [pii] AID - 10.1345/aph.1D626 [doi] PST - ppublish SO - Ann Pharmacother. 2004 Jul-Aug;38(7-8):1236-42. doi: 10.1345/aph.1D626. Epub 2004 Jun 8.