Italian real-life experience of omalizumab

• Published in: Respiratory medicine Vol. 104; no. 10; pp. 1410 - 1416
• Main Authors: Cazzola, M, Camiciottoli, G, Bonavia, M, Gulotta, C, Ravazzi, A, Alessandrini, A, Caiaffa, M.F, Berra, A, Schino, P, Di Napoli, P.L, Maselli, R, Pelaia, G, Bucchioni, E, Paggiaro, P.L, Macchia, L
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.10.2010; Elsevier; Elsevier Limited
• Subjects: Adolescent; Adult; Aged; Allergies; Anti-Allergic Agents - therapeutic use; Antibodies, Anti-Idiotypic; Antibodies, Monoclonal - therapeutic use; Antibodies, Monoclonal, Humanized; Asthma; Asthma - drug therapy; Asthma - physiopathology; Biological and medical sciences; Chronic obstructive pulmonary disease, asthma; Clinical medicine; Dose-Response Relationship, Drug; Drug dosages; Drug therapy; Emergency medical care; Female; Forced Expiratory Volume - drug effects; Forced Expiratory Volume - physiology; Hospitalization; Hospitalization - statistics & numerical data; Humans; Italy; Male; Medical sciences; Middle Aged; Mortality; Omalizumab; Pneumology; Pulmonary/Respiratory; Quality of life; Severe asthma; Severity of Illness Index; Treatment Outcome; Young Adult; Italy; Omalizumab; Severe asthma; Lung disease; Italian; Respiratory disease; Bronchus disease; Obstructive pulmonary disease; Severe; Asthma; Pneumology
• ISSN: 0954-6111; 1532-3064
• DOI: 10.1016/j.rmed.2010.04.013

Summary 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 2224.68 μg/die) in association with long-acting β2 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 297.38 IU/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.