BioTeZ Berlin Buch GmbH

Germany

BioTeZ Berlin Buch GmbH

Germany
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Korn S.,Mainz University Hospital | Haasler I.,Mainz University Hospital | Fliedner F.,Mainz University Hospital | Becher G.,BecherConsult GmbH | And 4 more authors.
Respiratory Medicine | Year: 2012

Background: Benefit of treatment with the monoclonal anti-IgE-antibody omalizumab in severe IgE-dependent asthma requires a significant reduction of serum free IgE concentrations. It is unclear if monitoring free serum IgE is clinically meaningful once omalizumab treatment is initiated. Methods: Free IgE and omalizumab serum concentrations were quantified in 22 patients with severe asthma (68% female, 47 ± 11 yrs, mean (±SD) pre-bronchodilator FEV1 62 ± 13%, baseline mean (±SEM) free serum IgE 652 ± 136 ng/ml) treated with omalizumab for 4 months using a Recovery-ELISA. Results: Omalizumab treatment reduced free serum IgE prior to the second omalizumab injection by 73%, after 16 weeks by 81% to 58 ± 12 ng/ml (p < 0.001 vs. baseline). 17 patients responded to anti-IgE therapy as judged by physician-rated global evaluation of treatment effectiveness. There was neither a relation between free serum IgE concentrations and treatment response nor a significant or clinically relevant correlation between free IgE levels and changes in lung function, exhaled NO, asthma control, and quality of life. Serum concentrations of omalizumab were detected in all patients and reached a stable phase within 8 weeks. Conclusions: Monitoring free IgE and omalizumab serum concentrations in patients treated with omalizumab does not predict clinical response nor does it add to the decision to continue or stop treatment. However, routine measurements of free IgE may be clinically relevant to demonstrate an adequate reduction in free IgE in patients not responding to omalizumab therapy. © 2012 Published by Elsevier Ltd.


Strohner P.,BioTeZ Berlin Buch GmbH | Staatz A.,BioTeZ Berlin Buch GmbH | Sarrach D.,BioTeZ Berlin Buch GmbH | Steiss J.-O.,Justus Liebig University | Becher G.,BecherConsult GmbH
Clinical Chemistry and Laboratory Medicine | Year: 2012

Therapeutic antibodies are an important part of Biopharmaceuticals. They are highly innovative and specific drugs. Additionally, they play a challenging role in new demands in diagnostics because they disturb conventional antibody-based tests, such as immunoassays. The recovery ELISA is a newly developed immunoassay technology for monitoring such therapeutic antibodies or comparable biologics during the therapy. The recovery ELISA determines three results in one test: the free level of antigen (if available in serum), the level of therapeutic antibody and the specific dose-response interaction. The free level of antigen is the amount that can be measured in the immunoassay, as it exists unmasked under assay conditions. The relationship between therapeutic antibody level and neutralization rate of target protein is shown by the so-called 'recovery curve'. The recovery ELISA is demonstrated with the example of Omalizumab/IgE. © 2012 by Walter de Gruyter • Berlin • Boston.


PubMed | Charité - Medical University of Berlin, IPM Biotech GmbH, Copenhagen University and BioTeZ Berlin Buch GmbH
Type: | Journal: The Journal of allergy and clinical immunology | Year: 2016

A slow response to omalizumab (anti-IgE) in CSU patients is strongly correlated with IgG-anti-FcRI-mediated serum-induced basophil histamine release suggesting that, in these patients, effects on FcRI are critical for the mechanism of action of omalizumab.


Steiss J.O.,Justus Liebig University | Schmidt A.,Justus Liebig University | Lindemann H.,Justus Liebig University | Rudloff S.,Justus Liebig University | And 5 more authors.
Atemwegs- und Lungenkrankheiten | Year: 2011

Background: Omalizumab is a successfully implemented supplementary therapy for improving asthma control in children aged 6 years and older with severe persistent allergic asthma. The dosage of omalizumab depends on body weight and IgE level, yet no parameter has been established to guide dosage changes during therapy. Clinical studies in patients with allergic asthma or allergic rhinitis revealed a clinically relevant improvement by using omalizumab leading to concentrations of free serum IgE reported to be lower than 50 ng/ml. Therefore, only the question concerning the concentrations of free IgE used in a therapy with omalizumab is regarded of clinical importance, while total IgE (free and omalizumab-bound IgE) increases during treatment. Patients and methods: Ten patients, 8 to 17 years of age, received therapy with omalizumab due to severe allergic asthma. In addition, the patients had pronounced rhinoconjunctivitis, food allergy, insect sting allergy, and/or neurodermitis. The total IgE in the serum was measured in the patients 3-6 monthly before each omalizumab injection as a potential progress parameter (Sandwich-Immunoassay ADVIA Centaur). Results: Six months after beginning of the therapy with omalizumab, a significant decrease of the total IgE concentration was found, in comparison to the baseline values (p < 0.003). In all patients the tolerability of omalizumab was very good: there was a reduction in the frequency of the asthma exacerbations and rescue medications. All patients reported a clearly improved quality of life. Conclusions: A general increase in IgE was not observed in any of the children we treated with omalizumab. Apart from the development of routine assays to determine free serum IgE levels, the significance of the total serum IgE as a suitable control of an omalizumab therapy should be further investigated in controlled studies with regard to sensitivity and specificity. In order to only administer the lowest necessary dose of omalizumab especially in children and adolescents, the establishment of laboratory parameters (free IgE and/or total IgE) to adequately monitor the therapy is urgently needed. Patients undergoing an omalizumab therapy require medical supervision at close intervals. © 2011 Dustri-Verlag Dr. Karl Feistle.

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