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Add-On Therapy With Omalizumab in Severe Allergic Asthma Effective, Safe in Real-Life Setting: Presented at EAACI By Judith Moser, MD WARSAW, Poland -- June 9, 2009 -- According to a postmarketing surveillance study presented here at the 28th Congress of the European Academy of Allergy and Clinical Immunology (EAACI), add-on therapy with omalizumab leads to symptom improvement in patients with severe allergic asthma. The postmarketing surveillance study (XCLUSIVE [Compliance and Utilization Investigation Under Real-Life Conditions]) was conducted at 85 German centres. A total of 195 patients participated. "The study investigated the add-on therapy with omalizumab in real-life conditions," stated Matthias Bräutigam, MD, Clinical and Regulatory Affairs, Novartis Pharma GmbH, Nuremberg, Germany, on presenting the data here on June 8. The efficacy of the treatment was evaluated by means of the Global Evaluation of Treatment Effectiveness (GETE), lung function measurements (forced expiratory volume in the first second of expiration [FEV1]), and assessment of the exacerbation rates after 16 weeks. Furthermore, a symptom score (Asthma Control Questionnaire [ACQ]) was assessed after 16 weeks and 6 months. "A question of interest was the patient compliance," Dr. Bräutigam said. For this purpose, biweekly and monthly subcutaneous administrations were compared in this respect. After a 16-week treatment, the lung function as measured by the FEV1 had slightly increased by 13.7% (P < .05 vs baseline). The exacerbation rates showed a sharp decrease by 74.9% (P < .0001 vs baseline). Also, the percentage of days of absence had dropped by 92.1% (P < .001 vs baseline). In 78.8% of the cases, physicians rated the treatment efficacy as good or excellent according to GETE. "This is equal to the definition of a treatment response," Dr. Bräutigam said. The symptom score as assessed by ACQ improved from 3.6 to 2.0 (-43.7%; P < .0001) and 1.9 (-46%; P < .0001) after 16 weeks and 6 months, respectively. "Patient compliance was independent of the injection interval," Dr. Bräutigam emphasised. Significant adverse events associated with the use of omalizumab were not observed. "In this real-life setting, the efficacy of omalizumab was even slightly better than in the large controlled studies," Dr. Bräutigam summarised. Funding for this study was provided by Novartis Pharma GmbH. Presentation title: Efficacy of Omalizumab in the Therapy of Severe Persistent Bronchial Asthma - XCLUSIVE - Compliance and Utilization Investigation Under Real-Life Conditions. Abstract 787 E-mail this page to a friend or colleague! To print, use this version