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| |  Omalizumab Reduces Systemic Allergic Reactions to Immunotherapy in Patients With Allergic Asthma: Presented at EAACI By Judith Moser, MD WARSAW, Poland -- June 9, 2009 -- A pretreatment with omalizumab for specific immunotherapy is well tolerated in patients with persistent symptomatic asthma and significantly reduces the percentage of patients with serious systemic allergic reactions to immunotherapy, according to a study presented here at the 28th Congress of the European Academy of Allergy and Clinical Immunology (EAACI). The potential for serious systemic allergic reactions (SARs) is a limitation for immunotherapy (IT), particularly in patients with persistent symptomatic asthma. Thomas B. Casale, MD, Department of Medicine, Creighton University, Omaha, Nebraska, presented the results of a randomised, double-blind trial assessing the tolerability of IT after pretreatment with omalizumab, in a poster presentation on June 8. "The purpose of the study was to determine whether omalizumab given before a cluster immunotherapy regimen, which is a more rapid dosing scheme, is protective in preventing allergic reactions to the allergy shots," explained Dr. Casale. Adult patients with a history of at least moderate persistent asthma, which was not well controlled with inhaled corticosteroids, were randomised to either omalizumab (n = 126) or placebo (n = 122) for 12 weeks followed by 2 IT phases (cluster IT and maintenance IT). An antihistamine pretreatment was permitted at each investigator's discretion. The primary efficacy variable was the occurrence of SARs to the specific IT. In the core study, 19.8% experienced an SAR after initiating specific IT. "We found that omalizumab prevented about 50% of the acute allergic reactions to immunotherapy," Dr. Casale reported. "This is important, for we tend not to use immunotherapy in patients with asthma that are not well controlled because it is too risky." The omalizumab pretreatment resulted in a significantly lower proportion of patients experiencing SARs to specific IT (13.5% vs 26.2% for placebo, P = .017). "The addition of antihistamines did not make any difference," Dr. Casale emphasised. In both subgroups with and without antihistamine pretreatment, SARs occurred in only half of the patients receiving omalizumab compared with the placebo group. Adverse events that were considered to be related to either omalizumab or placebo were reported in 9 patients (omalizumab, n = 4; placebo, n = 5). Seven patients experienced serious adverse events, but none of these were considered to be related to the study medication. "Our findings show that omalizumab is protective for these groups of patients," Dr. Casale concluded. Funding for this study was provided by Novartis Pharmaceuticals Corporation. [Presentation title: Effect of Pretreatment With Omalizumab With or Without Antihistamines on the Tolerability of Immunotherapy in Patients With Asthma Inadequately Controlled With Inhaled Corticosteroids. Abstract 886]
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