An Observational, Retrospective Multicentre Medical Record Review to Describe the Post-authorisation Early Clinical Experience of Dupilumab in the Treatment of Adult Severe Asthma

Study Overview
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Brief Summary
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The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.

Detailed Description
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Participants initiating treatment with dupilumab in the UK between 5th July 2019 and 12th August 2021 will be included in the study record review, permitting participation in research and if medical records are available for review. No intervention will be administered in this clinical trial. Data will be collected from hospital medical records and other hospital databases.

Official Title
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Real-world Experience of Dupilumab for the Treatment of Severe Asthma in the United Kingdom: a Retrospective Study

Conditions
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Asthma

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult participants (aged ≥18 years at index) with severe asthma, initiated with dupilumab treatment (≥1 dose) between 07/05/2019 (EU licence) and 08/12/2021 Participants with ≥1 routine asthma clinic visit recorded within 6 months prior to or on the date of dupilumab initiation and ≥1 routine asthma clinic visit recorded between 9 and 16 months post-dupilumab initiation Exclusion Criteria: Participants known to have opted out of participation in research Participants whose medical records are not available for review The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Group 1<br>The source population for this study is adult participants with severe asthma treated with dupilumab in routine clinical practice in the UK. | Other: No intervention<br>* Non-interventional study based on secondary use of hospital medical records<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral corticosteroid (OCS) dose | Measured per day | Up to 25 months | 
| Annual asthma exacerbation rate | The annual exacerbation rate will be calculated as the sum of OCS exacerbations and the hospital asthma exacerbations that occurred more than 7 days separated from other exacerbations. Exacerbations will be defined according to whether or not the patient was receiving asthma maintenance OCS. | Up to 25 months | 
| Forced expiratory volume in one second (FEV1) | FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer measured in L | Up to 25 months | 
| Peak expiratory flow rate (PEF) | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter measured in L/min. | Up to 25 months | 
| Asthma Control Questionnaire (ACQ) score | Total scores for the different versions of ACQ (5/6/7) are highly correlated and measurement properties are reported to be similar but results will be reported separately according to the version used. Differences in ACQ will only be calculated where the same version was used for the time points being compared. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control. | Up to 25 months | 
| Asthma Quality of Life Questionnaire (AQLQ) score | Overall scores for the mini-AQLQ and the AQLQ have been reported to be very similar but results will be reported separately according to the version used. Differences in AQLQ will only be calculated where the same version was used for the time points being compared. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life. | Up to 25 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI [kg/m2]) | Calculated as weight at baseline (kg) divided by height in m2 | At baseline | 
| Inhaled corticosteroid dose | Measured per day | At baseline | 
| Dupilumab treatment duration | Time from the first dose to the last recorded dose (information on treatment interruptions will not be collected). | Up to 25 months |