title: Immunological and clinical changes in allergic asthmatics following treatment with omalizumab.
abstract: IgE plays a key role in allergic asthma. We investigated whether omalizumab treatment of patients with moderate to severe allergic asthma leads to changes in inflammatory mediators and clinical symptoms. This sub-study was conducted on 35 patients with a positive skin prick test (SPT) requiring daily administration of beclomethasone dipropionate (500-1,000 microg), who participated in a multicentre, randomised, double-blind, placebo-controlled study. Omalizumab or placebo was administered at 0.016 mg/kg/IgE every 4 weeks. Patients recorded peak expiratory flow, asthma symptom score and beta(2)-agonist use in daily diaries and spirometry was performed at each visit. beta(2)-Agonist use and SPT wheal reaction decreased significantly (p < 0.05). Circulating levels of IL-5, IL-6, IL-8, IL-10, IL-13 and s-ICAM were measured before and after 16 weeks of treatment. IL-13 and s-ICAM were measured before and after 16 weeks of treatment. IL-13 decreased significantly (p < 0.01). IL-5 and IL-8 decreased in the omalizumab group compared to baseline. The other circulating mediators did not demonstrate any changes. Histamine release was significantly reduced (p < 0.01). Airway resistance (p < 0.05) and the provocative concentration inducing a 20% decrease in FEV(1) (p < 0.05) were measured before, after 16 weeks, and 3 months after completion of treatment. Both parameters decreased significantly (p < 0.05). Peripheral eosinophil count decreased significantly compared to placebo (p < 0.01). These findings suggest that omalizumab has potential as a novel treatment for allergic asthma.
authors.affiliation: Allergy and Asthma Clinic, Charité, Humboldt University, Berlin, Germany. oliver.nago@charite.de
authors.forename: Oliver
authors.initials: O
authors.lastname: Noga
authors.forename: Gerald
authors.initials: G
authors.lastname: Hanf
authors.forename: Gert
authors.initials: G
authors.lastname: Kunkel
mesh_terms: D000328:Adult; D000403:Airway Resistance / Q000187:drug effects; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000276:immunology* / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000276:immunology*; D004311:Double-Blind Method; D004804:Eosinophils / Q000187:drug effects / Q000378:metabolism; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006636:Histamine Release / Q000187:drug effects; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000187:drug effects; D007378:Interleukins / Q000378:metabolism; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D012882:Skin Tests; D016896:Treatment Outcome
chemical_list: D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007378:Interleukins; D000069444:Omalizumab; D007073:Immunoglobulin E