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 months 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.
Current data from clinical studies show that patients with severe allergic asthma experience a significant improvement from omalizumab. The early and late allergic reactions are inhibited by formation of complexes with free circulating immunoglobulin E (IgE), independent of which antigen activates the allergic cascade. The dosage of omalizumab depends on body weight and IgE level, yet no parameter has been established to guide dosage changes during therapy. The aim of this study was to investigate the value of the determination of total IgE by ADVIA Centaur assay to monitor the therapy progress. Nine patients, 8 to 17 years of age, received therapy with omalizumab due to severe allergic bronchial asthma. In addition, the patients had pronounced rhinoconjunctivitis, food allergy, insect sting allergy, and/or neurodermitis. The total IgE in the serum (Sandwich-Immunoassay ADVIA Centaur) was measured in the patients once monthly before each omalizumab injection as a potential progress parameter. Six months after the beginning of therapy with omalizumab, a significant decrease of the total IgE concentration was found, in comparison to the baseline values (p < 0.01). In all patients, the tolerability of omalizumab was very good; there was a reduction in the frequency of the asthma exacerbations and rescue medications. The dosage of inhaled glucocorticoids could be lowered. All patients reported a clearly improved quality of life. The increase of the total IgE concentrations after administration of omalizumab described in the literature could not be confirmed. The value of total serum IgE as a progress parameter should be investigated in controlled studies with regard to sensitivity and specificity of the respective assays. The establishment of a test procedure for therapeutic monitoring appears urgently necessary, so that the appropriate dosage of omalizumab is applied in children and adolescents. Patients receiving omalizumab therapy should be closely monitored.
DNASTAT is a collection of Pascal routines for researchers who develop their own application programs for statistical analysis of DNA and protein sequences. Dynamic and file-based data structures allow users to process sets of sequences by simple loop control without limitations on the number of sequences and their individual sizes. This frees the programmer from potentially error-prone tasks like dynamic memory allocation and controlling array sizes. Sequences can be stored in databases along with biological and statistical attributes. Individual sequences can be accessed by column name and row number as with spreadsheets. DNASTAT allows large sets of sequences to be processed using a PC with standard configuration. Its small size, simplicity and free availability make it attractive to students of mathematical biology. Use of DNASTAT is illustrated by two sample programs that generate a database of coding regions from the GenBank entry of the tobacco chloroplast genome. A version of DNASTAT written in ANSI-C for PCs and Unix workstations is also available.
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