This study is aimed at evaluation of the efficacy of mepolizumab 100 mg subcutaneously (SC) every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Target population to be recruited has been set at 130 subjects from at least 6 asthma centers throughout the country. Data on demographics and asthma status will be collected using questionnaires at 3 time-points: pre-mepolizumab (pre-MEPO), after 24 weeks of mepolizumab (MEPO) and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks). Primary endpoints will include: * Asthma exacerbations measured at qualification for the treatment (in the period of previous 52 weeks) and at the 24th and 52nd week of the treatment. * Oral Corticosteroids use dose (documented at qualification for the treatment and at the 24th and 52nd week of the treatment).
This study is aimed at evaluation of the efficacy of mepolizumab 100 mg SC every 4 weeks in patients with severe eosinophilic asthma who have been treated for at least 12 months in several Polish allergy/asthma centres under the same protocol. Retrospective multicentre observational study will involve 130 patients with severe eosinophilic asthma (SEA) who have been treated in six Severe Asthma Treatment Centres (SATCs) in Poland. In each SATC all data available in the program questionnaires will be transferred to the Study Data Sheet (questionnaire), and will be send to the study coordinator within 5 months from the study beginning The start-up meeting including partners from all centres involved will be organized to discuss the study protocol and to unify data collection The evaluation parameters (exacerbations rate, OCS dose) will be analysed at least at three time points: pre-MEPO, after 24 weeks of MEPO and after 1 year of MEPO administration (some of the outcomes will be observed every 4 weeks, for the details see 'study endpoints' section). In addition the following parameters which are available in patients' records will be analysed: * 5-item asthma control questionnaire (ACQ-5) score (measured at qualification for the treatment and every 4 weeks thereafter) * Asthma quality of life questionnaire (AQLQ) score (measured at qualification for the treatment and every 4 weeks thereafter) * Pre-bronchodilator FEV1 (measured at qualification for the treatment and every 4 weeks thereafter) Research activities will include: * collecting raw data from the clinical centres (paper version) and constructing a raw dataset (digital version), * data cleaning, computation of variables, * statistical analysis typical for pre-post study design (the statistical analysis will be outsourced to the specialized private institute). Clinical improvements observed at 24 weeks and at 52 weeks of treatment with Mepolizumab will be referred to the following characteristics of patients at baseline: * demographics, * presence of comorbidities including the atopic status, * concomitant pharmacotherapy, * clinical status, * eosinophilia. We will control for mepolizumab use regarding dose, treatment duration and dosing frequency as well as for the safety profile based on the AEs reporting in the medical documentation. Data Source / Data Collection Patients recruited to the study had been treated with mepolizumab between December 2017 and December 2019.All the data planned to be used in the proposed study were systematically collected in the form of the clinical documentation (paper version) and will be transferred in the study centres into the study. Data Sheets. Collaborating Researchers (Severe Asthma Centres' Leaders) will provide the data input into the dedicated online questionnaire. Study Population 130 Patients who were treated with mepolizumab in six severe-asthma clinics in Poland between December 2017 and December 2019 . In the drug program in Poland it was mandatory to conduct the control examinations at the 24th and 52nd week of the treatment . In the proposed study we will use this information to evaluate study endpoints. Only patients who have been treated for at least 52 weeks are included into the study Variables concerning the primary endpoints * Asthma exacerbations measured at qualification for the treatment (in the period of previous 52 weeks) and at the 24th and 52nd week of the treatment. * Oral Corticosteroids use dose (documented at qualification for the treatment and at the 24th and 52nd week of the treatment) Variables concerning the secondary endpoints: * ACQ-5 score (measured at qualification for the treatment and every 4 weeks thereafter) * AQLQ score (measured at qualification for the treatment and every 4 weeks thereafter) * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) (measured at qualification for the treatment and every 4 weeks thereafter) * Blood eosinophil counts (measured at qualification for the treatment and at the 24th and 52nd week of the treatment)
Study Type
OBSERVATIONAL
Enrollment
106
Mepolizumab administered within the frame of a severe asthma treatment program financed by National Health Fund in Poland for patients fulfilling specific criteria of asthma severity.
Medical University of Lodz, Dept. of Immunology and Allergy
Lodz, Poland
Asthma Exacerbations During 52 Weeks Preceding Treatment Initiation (as Assessed at Baseline) and at the 24th and 52nd Week of the Treatment
Data as transferred from the treatment program questionnaires to the Study Data Sheet. Asthma exacerbations, defined according to the Polish drug programme, is the worsening in asthma requiring (1) use of systemic corticosteroids or (2) increase in dose of OCS for more than 3 days in case of patients who are chronically treated with OCS.
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Number Patients Requiring Treatment With Oral Corticosteroids (OCS) at a Chronic Basis (Documented at Qualification for the Treatment and at the 24th and 52nd Week of the Treatment)
Data as transferred from the treatment program questionnaires to the Study Data Sheet
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
ACQ-5 (Asthma Control Questionnaire 5-item) Score
Asthma Control Questionnaire (ACQ) is the validated tool aimed to measure the adequacy of asthma control and change in asthma control occurring either spontaneously or as a result of treatment. It is self-administered by patients and assesses asthma symptoms intensity and frequency (5 items) on a 7-point scale (0 through 6; 0=absence, 6= maximum intensity/frequency), with total score being the average of the questions. ACQ score ranges from 0 (minimum) to 6 (maximum). A score of 1.5 or more indicates that a patient has inadequate asthma control. Difference in score of 0.5 or greater is considered clinically important (MCID, minimal clinically important difference).
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
AQLQ (Asthma Quality of Life Questionnaire) Score
Asthma Quality of Life Questionnaire (AQLQ) is a disease-specific tool covering both physical and emotional impact of asthma upon the affected subjects' quality of life. This questionnaire has 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. The AQLQ has been validated in 2 variants: a standard AQLQ consisting of 32 items and a mini-AQLQ containing 15 items. In the national severe asthma treatment program in Poland a 15-item AQLQ is used, as per National Health Fund requirements. Items are scored on a 7-point Likert scale, with score 1 representing maximal impairment and the value of 7 attributed to "no impairment". The total score is calculated as a mean value of all items (a sum of scores divided by 15). A change of \>0.5 points is considered clinically significant. Score below 5 indicates considerable lowering of quality of life in an asthmatic subject and is one of the conditions for inclusion into the reimbursed treatment program.
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Pre-bronchodilator FEV1
Pre-bronchodilator FEV1 (forced expiratory volume in 1 second) is a key indicator in lung funtion testing, measuring the volume of air exhaled from the lungs in the first second of a maximum forced exhalation. FEV1 is commonly used to diagnose and monitor obstructive lung diseases, including asthma. Values below 80% of the predicted value (calculated individually using basing on subject's age, sex, height, weight and ethnicity) indicates narrowing of the airways.
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
Blood Eosinophil Counts
Data as transferred from the treatment program questionnaires to the Study Data Sheet
Time frame: Baseline (before mepolizumab initiation); week 24; week 52
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