title: Italian real-life experience of omalizumab.
abstract: Omalizumab is a humanized murine monoclonal antibody directed toward a portion of the IgE indicated in Europe for the treatment of severe persistent allergic asthma, inadequately controlled despite high-dose of ICS (mean BDP equivalent dose of inhaled corticosteroid 2224.68microg/die) in association with long-acting beta(2) agonists. Our aim was to describe the experience, efficacy and safety in a cohort of Italian patients treated with omalizumab in a real-life clinical setting. One hundred and forty two patients from 13 Italian Centers were observed and analysed. The dosage of omalizumab was established according to the labelling indication, with a median dose of IgE of 297.38IU/ml or kU/l. During the previous year, all patients experienced frequent exacerbations (mean=4.87), emergency visits (mean=4.45) and hospitalisation (mean=1.53). Following treatment with omalizumab, the annual rate of exacerbations, emergency visits and hospitalisation decreased by 79%, 88% and 95%, respectively. The proportion of patients without exacerbation, not needing emergency visits and hospitalization increased by 610%, 154% and 28%, respectively. The response to omalizumab measured with the GETE (global evaluation of treatment effectiveness) scale rated as good to excellent in 77% of patients. Overall, 9.6% (n=9) of the patients experienced one single adverse effect. Only one patient reported a serious adverse event (local reaction at the site of injection) leading to interruption of treatment. The observed reduction of asthma-related events in particularly poorly controlled patients in this Italian real-life setting is consistent with the results of other observational studies.
authors.affiliation: Unità di Farmacologia Clinica Respiratoria, Dipartimento di Medicina Interna Università di Roma Tor Vergata, Roma, Italy. mario.cazzola@uniroma2.it
authors.forename: M
authors.initials: M
authors.lastname: Cazzola
authors.forename: G
authors.initials: G
authors.lastname: Camiciottoli
authors.forename: M
authors.initials: M
authors.lastname: Bonavia
authors.forename: C
authors.initials: C
authors.lastname: Gulotta
authors.forename: A
authors.initials: A
authors.lastname: Ravazzi
authors.forename: A
authors.initials: A
authors.lastname: Alessandrini
authors.forename: M F
authors.initials: MF
authors.lastname: Caiaffa
authors.forename: A
authors.initials: A
authors.lastname: Berra
authors.forename: P
authors.initials: P
authors.lastname: Schino
authors.forename: P L
authors.initials: PL
authors.lastname: Di Napoli
authors.forename: R
authors.initials: R
authors.lastname: Maselli
authors.forename: G
authors.initials: G
authors.lastname: Pelaia
authors.forename: E
authors.initials: E
authors.lastname: Bucchioni
authors.forename: P L
authors.initials: PL
authors.lastname: Paggiaro
authors.forename: L
authors.initials: L
authors.lastname: Macchia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects / Q000502:physiology; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D000069444:Omalizumab; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D000888:Antibodies, Anti-Idiotypic; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069444:Omalizumab