The goal of this exploratory and observational prospective study is to study the composition and phenotypes of blood leukocytes collected from asthmatic patients before and after instantiated treatment with the interleukin-5 neutralizing antibody mepolizumab. Comparisons will be made to leukocyte profiles in patients already on mepolizumab treatment, asthma patients without any biological treatment, and non-diseased control subjects.
Asthma is a chronic inflammatory and obstructive condition affecting the airways. The disease is commonly associated with elevated blood eosinophils and tissue eosinophilia. Many aspects of the pathophysiological mechanisms and clinical symptoms are controlled by conventional therapies such as inhaled corticosteroids (ICS) and long acting β2 agonists. However, some patients remain clinically uncontrolled and need additional treatment such as direct targeting of eosinophil granulocytes by neutralizing the eosinophil-promoting cytokine interleukin 5 (IL5). Mepolizumab is a humanized monoclonal IL-5 neutralizing antibody that is used to treat patients with moderate-severe eosinophilic asthma. While a marked reduction of eosinophils is a key effect of mepolizumab, the exact mechanism of action is unknown. Apart from basophils, that also express the receptor for IL-5, other leukocytes are likely to be indirectly affected by the suppressed eosinophilia. In addition, it is largely unknown to what extent the few eosinophils remaining after anti-IL5 treatment differ from pre-treatment eosinophils. The present study is a prospective observational asthma study that aims to use microscopic analysis to investigate the composition and subtypes of blood leukocytes collected before and after instantiated mepolizumab treatment. Comparisons are made to patients already on mepolizumab treatment, asthma patients without any biological treatment, and non-diseased control subjects.
Study Type
OBSERVATIONAL
Enrollment
80
Mepolizumab is administered by subcutaneous injection with guideline recommended patient selection and dosing for treatment of eosinophilic asthma. Accordingly, the Mepolizumab treatment is given as add-on therapy to standard inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
Routine asthma treatment with inhaled corticosteroids (ICS) and long-acting beta 2 agonists (LABA)
The Lung and Allergy Clinic, Skåne University Hospital (SUS)
Lund, Skåne County, Sweden
RECRUITINGChange in Blood Eosinophil Marker Expression
Quantitative immunohistochemical analysis of eosinophil marker expression in blood leukocyte pellets
Time frame: Change from baseline at 1-3 days, 1 week, 4 weeks, and 4 months after initiated biological treatment
Change in Blood Basophil Marker Expression
Quantitative immunohistochemical analysis of basophil marker expression in blood leukocyte pellets
Time frame: Change from baseline at 1-3 days, 1 week, 4 weeks, and 4 months after initiated biological treatment
Change in Blood Leukocyte Composition
Immunohistochemical determination of the relative proportion (percent) of the leukocyte populations in blood leukocyte pellets
Time frame: Change from baseline at 1-3 days, 1 week, 4 weeks, and 4 months after initiated biological treatment
Change in Blood T Lymphocyte Marker Expression
Quantitative immunohistochemical analysis of T lymphocyte marker expression in paraffin-embedded blood leukocyte pellets
Time frame: Change from baseline at 1-3 days, 1 week, 4 weeks, and 4 months after initiated biological treatment
Change in Blood B Lymphocyte Marker Expression
Quantitative immunohistochemical analysis of T lymphocyte marker expression in paraffin-embedded blood leukocyte pellets
Time frame: Change from baseline at 1-3 days, 1 week, 4 weeks, and 4 months after initiated biological treatment
Leukocyte Total Cell Counts
Routine hemacytometer total leukocyte cell counts
Time frame: Change from baseline at 1-3 days, 1 week, 4 weeks, and 4 months after initiated biological treatment
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