Comparison of Biologicals in Treatment of Severe Asthma

Study Overview
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Brief Summary
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This is a retrospective clinical study on adult patients (18 years or more) with biological therapy for severe asthma at the Helsinki University Central Hospital (HUCH). This is a real-life study with a broader patient population than in a randomized controlled trial. Omalizumab has been used for treatment of asthma in HUCH since January 2009, anti-IL5 therapies starting with mepolizumab since April 2016.

Detailed Description
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The investigators collect and analyse results of anti-IL5/IL5R and anti-IgE therapies in asthma until October 2019.The investigators compare number of exacerbations, number of glucocorticoid courses, dose of per oral glucocorticoid, number of antibiotic courses, need of emergency care and hospitalizations because of asthma before use of biologicals and at the latest visits of the participants when using biologicals.

Official Title
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Comparison of Biologicals in Treatment of Severe Asthma - Real Life Experiences

Conditions
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Asthma

Intervention / Treatment
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* Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: asthma that remains uncontrolled despite moderate to high dose inhaled corticosteroid and additional therapy with at least one other controller medication and need for continuous per oral corticosteroids (OCS) or contraindications (or clinically significant side effects of OCS) against OCS and/or frequent courses (two or more per year) of OCS Exclusion Criteria: patients without asthma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| anti-IL5/IL5R-therapy group<br>Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IL5/IL5R | Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab<br>* mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma<br>|
| anti-IgE-therapy group<br>Asthma patients, asthma and rhinitis, asthma and nasal polyps and anti-IgE-therapy | Drug: IL5 Antagonist or anti-IL5R-antibody or Omalizumab<br>* mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Exacerbations of the Participants | Change from the baseline in the number of courses of oral corticosteroids. Exacerbations of asthma estimated as number of courses of oral corticosteroids. | baseline (12 months before biologicals) and the latest (12 months after initiation of biologicals) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oral Corticosteroid Dose in Milligrams | Change in oral corticosteroid dose in milligrams | The baseline (at the time of the last outpatient before starting biologicals) and up to approximately 12 months for Anti-IL5/IL5R Therapy and approximately 44 months for the Anti-IgE Therapy | 
| Change in the Number of Courses of Antimicrobics | Change in the number of courses of antimicrobics | The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals | 
| Change in the Number of Emergency Room Visits of the Participants | Change in the number of emergency room visits of the participants | The baseline (at 12 months before biologicals) and the latest 12 months after initiation of biologicals |