1. Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy
- Author
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Christian Lupinek, Kurt Derfler, Silvia Lee, Thomas Prikoszovich, Oliver Movadat, Eva Wollmann, Carolin Cornelius, Milena Weber, Renate Fröschl, Regina Selb, Katharina Blatt, Dubravka Smiljkovic, Volker Schoder, René Cervenka, Thomas Plaichner, Gottfried Stegfellner, Hans Huber, Rainer Henning, Justyna Kozik-Jaromin, Thomas Perkmann, Verena Niederberger, Ventzislav Petkov, Peter Valent, Adelheid Gauly, Hans Peter Leinenbach, Ingrid Uhlenbusch-Koerwer, and Rudolf Valenta
- Subjects
Allergy ,Asthma ,Immunoadsorption ,IgEnio ,IgE ,Medicine ,Medicine (General) ,R5-920 - 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
- Published
- 2017
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