PMID- 12917972 OWN - NLM STAT- MEDLINE DCOM- 20030925 LR - 20181221 IS - 1469-493X (Electronic) IS - 1361-6137 (Linking) IP - 3 DP - 2003 TI - Anti-IgE for chronic asthma. PG - CD003559 AB - BACKGROUND: Omalizumab is a recombinant humanised monoclonal antibody directed against immunoglobulin E (IgE) to inhibit the immune system's response to allergen exposure. Omalizumab is directed against the binding site of IgE for its high affinity Fc receptor. It prevents free serum IgE from attaching to mast cells and other effector cells and prevents IgE mediated inflammatory changes. The complexes of Omalizumab and IgE formed as a result of treatment are small and not thought to be able to trigger complement activation or give rise to immune complex mediated pathology. OBJECTIVES: To determine the efficacy of anti-IgE in patients with allergic asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group Asthma trials register (February 2003) for potentially relevant studies. SELECTION CRITERIA: Randomised control trials examining anti-IgE administered in any manner for any duration. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed study quality and extracted and entered data. Three modes of administration were identified from the published literature (inhaled, intravenous and subcutaneous injection). Subgroup analysis was performed by asthma severity. Data were extracted from published and unpublished sources. MAIN RESULTS: Eight trials were included in the review, contributing a total of 2037 mild to severe allergic asthmatic participants with high levels of IgE. Treatment with intravenous and subcutaneous Omalizumab resulted in a 98 to 99% reduction in free IgE, reductions which were not observed following placebo treatment. Significant increases in the number of participants who were able to reduce (> 50% reduction in daily corticosteroid usage (four trials): odds ratio (OR) 2.50, 95% confidence interval (CI) 2.02 to 3.10; or completely withdraw their daily steroid intake (four trials): OR 2.50, 95%CI 2.00 to 3.13, were observed. Participants treated with Omalizumab were less likely to suffer an asthma exacerbation (stable steroid phase (three trials): OR 0.46, 95%CI 0.35 to 0.61; steroid reduction phase (three trials) OR 0.46, 95% CI 0.36 to 0.59). REVIEWER'S CONCLUSIONS: Omalizumab was significantly more effective than placebo at increasing the numbers of patients who were able to reduce or withdraw their inhaled steroids and was effective in reducing asthma exacerbations. Omalizumab was well tolerated, although the safety profile requires longer term assessment. Patient and physician assessment of the drug was positive. Further assessment in paediatric and severe adult populations is necessary, as is comparison with inhaled corticosteroids. FAU - Walker, S AU - Walker S AD - National Respiratory Training Centre, The Athenaeum, 10 Church Street, Warwick, UK, CV34 4AB. FAU - Monteil, M AU - Monteil M FAU - Phelan, K AU - Phelan K FAU - Lasserson, T J AU - Lasserson TJ FAU - Walters, E H AU - Walters EH LA - eng PT - Journal Article PT - Meta-Analysis PT - Review PT - Systematic Review PL - England TA - Cochrane Database Syst Rev JT - The Cochrane database of systematic reviews JID - 100909747 RN - 0 (Anti-Asthmatic Agents) RN - 0 (Antibodies, Anti-Idiotypic) RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (anti-IgE antibodies) RN - 2P471X1Z11 (Omalizumab) RN - 37341-29-0 (Immunoglobulin E) SB - IM CIN - ACP J Club. 2004 Jan-Feb;140(1):13. PMID: 14711284 UIN - Cochrane Database Syst Rev. 2004;(3):CD003559. PMID: 15266491 MH - Anti-Asthmatic Agents/therapeutic use MH - Antibodies, Anti-Idiotypic/*therapeutic use MH - Antibodies, Monoclonal/*therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Asthma/*drug therapy/immunology MH - Chronic Disease MH - Humans MH - Immunoglobulin E/blood MH - Omalizumab MH - Randomized Controlled Trials as Topic RF - 36 EDAT- 2003/08/15 05:00 MHDA- 2003/09/26 05:00 CRDT- 2003/08/15 05:00 PHST- 2003/08/15 05:00 [pubmed] PHST- 2003/09/26 05:00 [medline] PHST- 2003/08/15 05:00 [entrez] AID - 10.1002/14651858.CD003559 [doi] PST - ppublish SO - Cochrane Database Syst Rev. 2003;(3):CD003559. doi: 10.1002/14651858.CD003559.