Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy  Christian Lupinek, Kurt Derfler, Silvia Lee, Thomas Prikoszovich, Oliver Movadat,

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Presentation transcript:

Extracorporeal IgE Immunoadsorption in Allergic Asthma: Safety and Efficacy  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, Rudolf Valenta  EBioMedicine  Volume 17, Pages 119-133 (March 2017) DOI: 10.1016/j.ebiom.2017.02.007 Copyright © 2017 The Authors Terms and Conditions

Fig. 1 Enrollment, randomization and study design. (a) After screening (yellow; AV1, CV1 in b), subjects were allocated to the apheresis (blue) or the control group (pink). (b) Treatment-visits (AV2, AV3, etc.) are indicated by blue boxes, corresponding visits of the control group (CV2, CV3, etc.) by pink boxes. Intervals between treatment weeks, including control visits (AV5, CV4, etc.) are shown in white. The study was completed after a follow-up visit in week 16 (orange; AV14 and CV11). Weeks after randomization are shown at the bottom. pt./pts. – patient/s; IC – informed consent; AV – visit apheresis group; CV – visit control group. EBioMedicine 2017 17, 119-133DOI: (10.1016/j.ebiom.2017.02.007) Copyright © 2017 The Authors Terms and Conditions

Fig. 2 Relative IgE-depletion and absolute IgE-levels. (a) Mean (±SD) depletion rates (y-axes: % IgE-reduction) of total IgE (top chart), IgE to seasonal (center) and perennial allergen sources (bottom) are shown for each treatment visit (x-axes) of the apheresis group. (b) Absolute total IgE-levels (y-axis: U/ml) are shown as box-and-whisker plots for the screening visit, the first (Start) and the last visit (End) of each treatment cycle, for control- and follow-up visits (x-axis). Blue boxes show results for the treatment, red boxes for the control group, outliers are indicated by circles. The dashed line corresponds to median total IgE-levels for both groups at the screening visit. Significant differences between start and end of the respective cycle are indicated (**p≤0.01). EBioMedicine 2017 17, 119-133DOI: (10.1016/j.ebiom.2017.02.007) Copyright © 2017 The Authors Terms and Conditions

Fig. 3 Isotype specificity of IgEnio. Relative changes (y-axis: % changes to pre-treatment values) in serum IgM (gray), IgG (green), IgA (orange) and albumin (purple) are shown for each treatment cycle (x-axis) for the apheresis group. Error bars represent mean relative changes±standard deviations. Significant differences to changes in serum albumin are indicated (**p≤0.01). EBioMedicine 2017 17, 119-133DOI: (10.1016/j.ebiom.2017.02.007) Copyright © 2017 The Authors Terms and Conditions

Fig. 4 Changes in allergen-specific skin- and basophil-reactivity and in sIgE-levels. Relative changes (y-axes: fold changes) of (a) total wheal-areas from skin prick testing (SPT) and (b) of basophil-sensitivity (CD203c BAT – basophil activation test measuring CD203c upregulation; AUC – area under the curve) are shown as scatter plots for control and follow-up visits (x-axes) for birch (left) and grass pollen allergens (right). Results from individual subjects are colour-coded and displayed for the apheresis (filled circles) and for the control group (open boxes) with the respective median levels indicated by horizontal black lines for each group and visit. (c) Relative changes of sIgE-levels to birch (left) and grass (right) are displayed for the same subjects from (a) and (b) (top-charts: apheresis group, bottom-charts: control group). Weeks of study duration are shown underneath the x-axes with birch- and grass seasons highlighted by yellow boxes and treatment weeks in purple. Dashed horizontal lines indicate baseline levels. AV – visit apheresis group; CV – visit control group. EBioMedicine 2017 17, 119-133DOI: (10.1016/j.ebiom.2017.02.007) Copyright © 2017 The Authors Terms and Conditions

Fig. 5 Changes in peak flow and symptom scores. (a) Peak flow results (y-axis: l/s), (b) overall severity of allergy-related symptoms (y-axis: VAS – visual analogue scale) and (c) severity of lung symptoms (y-axis: lung symptom score), based on daily assessment by the patients, are shown for the complete study period (x-axes: days from treatment start). Blue curves represent results from the apheresis group and red curves from the control group. Error bars show mean values, ±SD. Treatment weeks are highlighted by purple boxes, birch and grass pollen seasons by yellow boxes. EBioMedicine 2017 17, 119-133DOI: (10.1016/j.ebiom.2017.02.007) Copyright © 2017 The Authors Terms and Conditions

Fig. 6 In vitro IgE-depletion from serum samples after addition of Omalizumab. Two serum samples with total IgE-levels<300U/ml (a, low IgE) or >1400U/ml (b, high IgE), without (yellow bars) and with different IgE-to-Omalizumab ratios (x-axes: 1:1 – pink bars; 1:40 – brown bars) were applied to IgEnio adsorber material. Relative depletion rates of total-IgE are shown (y-axes). EBioMedicine 2017 17, 119-133DOI: (10.1016/j.ebiom.2017.02.007) Copyright © 2017 The Authors Terms and Conditions

EBioMedicine 2017 17, 119-133DOI: (10.1016/j.ebiom.2017.02.007) Copyright © 2017 The Authors Terms and Conditions