Similarities and Differences of Biological Therapies for Severe Asthma.

Study Overview
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Brief Summary
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This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.

Detailed Description
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The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma. In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.

Official Title
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Similarities and Differences of Biological Therapies for Severe Asthma.

Conditions
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Asthma

Intervention / Treatment
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* Biological: Mepolizumab
* Biological: Omalizumab
* Biological: Reslizumab
* Biological: Benralizumab
* Biological: Dupilumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals of any age: adults and children. Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased. Being treated or not (control group) with biological drugs. Signed Informed Consent. Exclusion Criteria: None.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care<br>Patients with severe asthma being treated with non-biological standard therapies, mainly systemic corticosteroids. | |
| Biological therapies<br>Patients with severe asthma being treated with omalizumab, mepolizumab, reslizumab, benralizumab, or dupilumab. | Biological: Mepolizumab<br>* Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.<br>* Other names: Nucala®;Biological: Omalizumab<br>* Omalizumab will be prescribed freely by the treating physician according to real-life conditions.<br>* Other names: Xolair®;Biological: Reslizumab<br>* Reslizumab will be prescribed freely by the treating physician according to real-life conditions.<br>* Other names: Cinqair®;Biological: Benralizumab<br>* Benralizumab will be prescribed freely by the treating physician according to real-life conditions.<br>* Other names: Fasenra®;Biological: Dupilumab<br>* Dupilumab will be prescribed freely by the treating physician according to real-life conditions.<br>* Other names: Dupixent®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment dose scheduling and changes of dose throughout the study. |  | 2 years after inclusion | 
| Number of treatment discontinuations and causes of interruption throughout the study. |  | 2 years after inclusion | 
| Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study. |  | 2 years after inclusion | 
| Severity of Treatment-Related Adverse Events recorded throughout the study. |  | 2 years after inclusion | 
| Change of asthma control during the treatment. | Number of asthma exacerbations, change in FEV1, ACT, and blood eosinophilia, need of add-on medication, inhaled medication and systemic corticosteroids. | 2 years after inclusion |