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| EBioMedicine. 2017 Feb 12. pii: S2352-3964(17)30066-X. doi: 10.1016/j.ebiom.2017.02.007 |
| Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy. |
| Lupinek C1, Derfler K2, Lee S3, Prikoszovich T4, Movadat O5, Wollmann E6, Cornelius C7, Weber M8, Fröschl R9, Selb R10, Blatt K11, Smiljkovic D12, Schoder V13, Cervenka R14, Plaichner T15, Stegfellner G16, Huber H17, Henning R18, Kozik-Jaromin J19, Perkmann T20, Niederberger V21, Petkov V22, Valent P23, Gauly A24, Leinenbach HP25, Uhlenbusch-Koerwer I26, Valenta R27 |
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Abstract BACKGROUND: Prevention of IgE-binding to cellular IgE-receptors by anti-IgE (Omalizumab) is clinically effective in allergic asthma, 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 patients with allergic asthma and to investigate if IgEnio can bind IgE-Omalizumab 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 IgE-Omalizumab 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 IgE-Omalizumab 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 dyspnea, possibly was related to the treatment and resolved after administration of antihistamines and corticosteroids. CONCLUSIONS: This pilot study indicates that IgE immunoadsorption with IgEnio may be used to treat patients with pollen-induced allergic asthma. Furthermore, the treatment could render allergic patients with highly elevated IgE-levels eligible for the administration of Omalizumab and facilitate the desorption of IgE-Omalizumab complexes. This study was funded by Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany. |
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Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved. |
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KEYWORDS: Allergy, Asthma, IgE, IgEnio, Immunoadsorption |
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Publikations ID: 28254561 Quelle: öffnen |
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