BACKGROUND: Prevention of IgE-binding to cellular IgE-receptors by anti-IgE (Omalizumab) is clinically effective in @entity56 , but limited by IgE threshold-levels. To overcome this limitation, we developed a single-use IgE immunoadsorber column (IgEnio). IgEnio is based on a recombinant, IgE-specific antibody fragment and can be used for the specific extracorporeal desorption of IgE. OBJECTIVE: To study safety and efficacy of IgEnio regarding the selective depletion of IgE in a randomized, open-label, controlled pilot trial in @entity1 with @entity56 and to investigate if IgEnio can bind @entity13093 immune complexes. METHODS: Fifteen subjects were enrolled and randomly assigned to the treatment group (n=10) or to the control group (n=5). Immunoadsorption was done by veno-venous approach, processing the twofold calculated plasma volume during each treatment. A minimum average IgE-depletion of 50% after the last cycle in the intention-to-treat population was defined as primary endpoint. Safety of the treatment was studied as secondary endpoint. In addition, possible changes in allergen-specific sensitivity were investigated, as well as clinical effects by peak flow measurement and symptom-recording. The depletion of @entity13093 immune complexes was studied in vitro. The study was registered at clinicaltrials.gov (NCT02096237) and conducted from December 2013 to July 2014. RESULTS: IgE immunoadsorption with IgEnio selectively depleted 86.2% (  5.1% SD) of IgE until the end of the last cycle (p<0.0001). Removal of pollen allergen-specific IgE was associated with a reduction of allergen-specific basophil-sensitivity and prevented increases of allergen-specific skin-sensitivity and clinical symptoms during pollen seasons. IgEnio also depleted @entity13093 immune complexes in vitro. The therapy under investigation was safe and well-tolerated. During a total of 81 aphereses, 2 severe adverse events (SAE) were recorded, one of which, an episode of acute @entity1353 , possibly was related to the treatment and resolved after administration of @entity8610 and @entity288 . CONCLUSIONS: This pilot study indicates that IgE immunoadsorption with IgEnio may be used to treat @entity1 with pollen-induced @entity56 . Furthermore, the treatment could render @entity56 @entity1 with highly elevated IgE-levels eligible for the administration of Omalizumab and facilitate the desorption of @entity13093 complexes. This study was funded by Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany.

Extracorporeal IgE Immunoadsorption in XXXX : Safety and Efficacy.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1353 :: ('MESH:D004417', 'Disease') :: ['dyspnea'] @entity13093 :: ('MESH:C535745', 'Disease') :: ['IgE-Omalizumab'] @entity8610 :: ('MESH:D006633', 'Chemical') :: ['antihistamines'] @entity56 :: ('MESH:D004342', 'Disease') :: ['allergic asthma', 'allergic'] @entity288 :: ('MESH:D000305', 'Chemical') :: ['corticosteroids']
@entity56 :: (MESH:D004342,Disease) :: ['Allergic Asthma']
