Real-life, observational, retrospective, multicenter study to evaluate the effects of anti-IL5 biological treatments on blood total IgE Levels in atopic patients with severe eosinophilic asthma.
Severe asthma, i.e. asthma that is not controlled despite maximal optimized therapy and/or that worsens when high dose treatment is decreased (GINA guidelines - available at https://ginasthma.or), is a major unmet medical need. Major advances in the management of severe asthma occurred in the past few years due to the new targeted biological therapies. Mepolizumab and Benralizumab are humanized monoclonal antibodies able to block interleukin (IL)-5 and the receptor for IL-5, respectively. These biological treatments block the eosinophilic driven inflammation. The effects of these treatments on an other key effector molecule of the T2-immune response, i.e. IgE, is virtually unknown. To explore this issue, we set up a real life, observational, retrospective, multicenter study. The study will enroll patients with severe eosinophilic asthma already treated with Mepolizumab or Benralizumab. The following variable will be collected before the the biological treatment and at 4±2 months after the initiation of the pharmacological regimen: * demographic data * age of onset of asthma * smoking habit * concomitant pharmacological regimens * number of asthma exacerbations since last visit * concomitant diseases (particularly gastroesophageal reflux, nasal polyposis, atopic dermatitis, obesity, anxiety-depressive syndrome). * White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils) * Lung function tests (spirometry)
Study Type
OBSERVATIONAL
Enrollment
130
Levels of total IgE before biological treatments and at 4±2 months of treatments
White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
Levels of asthma control assessed by asthma control questionnaire (ACT) before initiation of biological treatments and at 4± months of treatments
Azienda Ospedaliero Universitaria Ferrara
Ferrara, Italy
Professor of Respiratory Medicine Department of Medical and Surgical Sciences University of Foggia - Italy
Foggia, Italy
UOC Pneumologia Ospedale L.Sacco - Polo Univestiario ASST Fatebenefratelli - Milano
Milan, Italy
IgE levels in mepolizumab group
To evaluate total IgE levels (kU/l) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months after initiation of anti-IL5 monoclonal antibody Mepolizumab
Time frame: 4±2 months
Total leucocytes in mepolizumab group
To evaluate total leucocytes (number of cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Time frame: 4±2 months
Eosinophils (number) in mepolizumab group
To evaluate the number of blood eosinophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Time frame: 4±2 months
Eosinophils (%) in mepolizumab group
To evaluate the percentage of blood eosinophils (%) total blood white cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Time frame: 4±2 months
Basophils (number) in mepolizumab group
To evaluate the number of blood basophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Time frame: 4±2 months
Basophils (%) in mepolizumab group
To evaluate the percentage of blood basophils (%) to totale white blood cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lung function tests performed before initiation of biological treatments and at 4± months of treatments
Malattie dell' Apparato Respiratorio Dipartimento di Scienza Mediche e Chirurgiche Materni-Infantili e dell'Adulto. Azienda Ospedaliero Universitaria di Modena
Modena, Italy
AOUP Giaccone Palermo, dipartimento PROMISE, Università di Palermo
Palermo, Italy
S.C di Pneumologia Ospedale S. Maria degli Angeli AAS5 Friuli Occidentale
Pordenone, Italy
Department of Medical Specialties, Pneumology Unit, Arcispedale Santa Maria Nuova, Azienda USL di Reggio Emilia-IRCCS
Reggio Emilia, Italy
UOC Pneumologia Azienda Ospedaliera Univeristaria Integrata - Verona
Verona, Italy
Time frame: 4±2 months
lymphocytes (number) in mepolizumab group
To evaluate the number of blood lymphocytes (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Time frame: 4±2 months
Lymphocytes (%) in mepolizumab group
To evaluate the percentage of blood lymphocytes (%) to total white cells in atopic patients with severe eosinophilic asthma at 4 ± 2 months from the start of treatment with anti-IL5 monoclonal antibody Mepolizumab
Time frame: 4±2 months
IgE levels in Benralizumab group
To evaluate total IgE levels (kU/l) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Time frame: 4±2 months
Total leucocytes in Benralizumab group
To evaluate total leucocytes (number of cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab compared to the pretreatment value
Time frame: 4±2 months
Eosinophils (number) in Benralizumab group
To evaluate the number of blood eosinophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Time frame: 4±2 months
Eosinophils (%) in Benralizumab group
To evaluate the percentage of blood eosinophils (%) total blood white cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Time frame: 4±2 months
Basophils (number) in Benralizumab group
To evaluate the number of blood basophils (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Time frame: 4±2 months
Basophils (%) in Benralizumab group
To evaluate the percentage of blood basophils (%) to totale white blood cells in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Time frame: 4±2 months
Lymphocytes (number) in Benralizumab group
To evaluate the number of blood lymphocytes (cell/µl) in atopic patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benralizumab
Time frame: 4±2 months
Lymphocites (%) in Benralizumab group
To evaluate the percentage of blood lymphocytes (%) to total white cells in atopic patients with severe eosinophilic asthma at 4 ± 2 months from the start of treatment with Benralizumab
Time frame: 4±2 months
respiratory function (FEV1 - liter) in Mepolizumab group
To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
respiratory function (FEV1 - %) in Mepolizumab group
To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
respiratory function (vital capacity - liter) in Mepolizumab group
To evaluate vital capacity (VC - liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
respiratory function (vital capacity - %) in Mepolizumab group
To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
respiratory function (forced vital capacity - liter) in Mepolizumab group
To evaluate forced vital capacity (FVC - liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
respiratory function (forced vital capacity - % predicted) in Mepolizumab group
To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
respiratory function (FEV1/FVC ratio) in Mepolizumab group
To evaluate FEV1/FVC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab compared to the pretreatment value.
Time frame: 4±2 months
respiratory function (FEV1/VC ratio) in Mepolizumab group
To evaluate FEV1/VC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
respiratory function (FEV1 - %) in Benralizumab group
To evaluate FEV1 (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
respiratory function (FEV1 - lier) in Benralizumab group
To evaluate FEV1 (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
respiratory function (FVC - liter) in Benralizumab group
To evaluate FVC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
respiratory function (FVC - %) in Benralizumab group
To evaluate FVC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
respiratory function (VC - liter) in Benralizumab group
To evaluate VC (liter) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
respiratory function (VC - %) in Benralizumab group
To evaluate VC (% predicted) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
respiratory function (FEV1/FVC ratio) in Benralizumab group
To evaluate FEV1/VC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab compared to the pretreatment value.
Time frame: 4±2 months
respiratory function (FEV1/VC ratio) in Benralizumab group
To evaluate FEV1/FVC ratio in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
Fractional exhaled nitric oxigen (FeNO) in Mepozumab group
To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Mepolizumab
Time frame: 4±2 months
Fractional exhaled nitric oxigen (FeNO) in Benralizumab group
To evaluate FeNO (ppb) in patients with severe eosinophilic asthma at baseline and at 4 ± 2 months from the start of treatment with Benraluzumab
Time frame: 4±2 months
Asthma control test in Mepolizumab group
To evaluate asthma control test (ACT) in patients with severe eosinophilic asthma at baseline and at baseline and at 4 ± 2 months from the start of Mepolizumab
Time frame: 4±2 months
Asthma control test in Benralizumab group
To evaluate asthma control test (ACT) in patients with severe eosinophilic asthma at baseline and at baseline and at 4 ± 2 months from the start of Benralizumab
Time frame: 4±2 months
correlation between eosinophils and total IgE
To evaluate the correlations (Pearson correlation coefficient) between the change in total eosinophil counts and IgE levels in patients treated with Mepolizumab or Benralizumab.
Time frame: 4±2 months
correlation between total IgE and lung function
To evaluate the correlations (Pearson correlation coefficient) between the change in total IgE levels and in functional parameters (FEV1, FVC and VC) in patients treated with Mepolizumab or Benralizumab.
Time frame: 4±2 months
correlation between total IgE and asthma control
To evaluate the correlations (Pearson correlation coefficient) between the change in total IgE levels and the change of asthma control (measured by asthma control test - ACT) in patients treated with Mepolizumab or Benralizumab.
Time frame: 4±2 months