Severe Asthma
Conditions
Keywords
Severe Asthma, IL5 antagonist
Brief summary
The goal of this observational study is to assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonists was initiated between 2012 and 2020. The main question\[s\] it aims to answer are: * What is the response rate after one year of treatment with IL5/IL5R antagonists. * What is the response and remission rate after one year of treatment with IL5/IL5R antagonists in subjects who fullfilled the original randomized control trials (RCTs) inclusion criteria compared with those who did not.
Detailed description
IL5/IL5-receptor (IL5R) antagonists are effective in reducing asthma exacerbations and have a corticosteroid sparing effect in selected severe eosinophilic asthmatics. The original randomized clinical trials that assessed the efficacy of IL5/IL5-R antagonists included highly selected patients who are not necessarily representative of the asthmatic population treated with IL5/IL5R antagonists in clinical practice. The aims of this study are: 1. To assess the response to treatment, in patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonists was initiated between 2012 and 2020. 2. To compare the response and remission rate after one year of treatment with IL5/IL5-R antagonists in asthmatics who would and would have not met the inclusion criteria of the original randomized clinical trials. We will perform a retrospective cohort study using data from the hospital charts of severe asthmatics treated with mepolizumab, reslizumab or benralizumab between November 2012 and December 2020 at the outpatient asthma clinic of a tertiary center (Sacre-Coeur Hospital) in Montreal. Cohort entry (CE) will be defined as the first prescription filled of IL5/IL5R antagonists. Authorization from the research ethics committee of the CIUSSS du Nord-de-l'île-de-Montréal and from the director of Professional Services was obtained. Statistical analysis Descriptive statistics will be used to summarize clinical, functional, and demographic characteristics of the patients of the whole cohort, as well as of the RCT in group and RCT out group. Baseline data will be recorded on the date closest to cohort entry. Results will be expressed as mean and standard deviation, except for data with a non-normal distribution, which were expressed as median and interquartile ranges and proportions for categorical variables. Chi-squared test and Student's t test will be used to compare patients' characteristics between RCT in group and RCT out group. All tests will be two-tailed, and the statistical significance level will be set at 0.05. Logistic regression analyses will be performed to identify factors associated with a positive response to treatment as well as the achievement of remission on treatment.
Interventions
DRUGIL5/IL5R Antagonists
Treatment with IL5/IL5R antagonists for one year
Sponsors
GlaxoSmithKline
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonist was initiated at the outpatient asthma clinic of a tertiary center (Sacre-Coeur Hospital) in Montreal.c between 2012 and 2020.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to IL5/IL5R Antagonist | one year | Percentage of subjects achieving response to IL5/IL5R antagonists. A response to treatment was defined as a reduction of asthma exacerbations of at least 50% or a 50% or higher reduction of the OCS doses for steroid dependant patients in the year following the initiation of an IL5/IL5R antagonist compared to the year preceding the initiation of the treatment. |
| Remission Rate With IL5/IL5R Antagonist | one year | Percentage of subjects achieving asthma remission. Clinical remission on treatment at one year was defined as no asthma exacerbation, no treatment with oral corticosteroid and a less than 10% decrease in pre-bronchodilator FEV1 compared with baseline value. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Randomized Clinical Trial (RCT) in Group Subjects who were aged 75 years or younger, had a smoking history of less than 10 pack-year, a forced expiratory volume in one second (FEV1) of less than 80% of the predicted value along with FEV1 reversibility of at least 12% and 200 ml. | 22 |
| Randomized Clinical Trial (RCT) Out Group Subjects who did not meet one of those criteria:
age 75 or younger FEV1 less than 80% FEV1 reversibility after bronchodilator of at least 12% and 200ml. | 86 |
| Total | 108 |
Baseline characteristics
| Characteristic | Randomized Clinical Trial (RCT) in Group | Randomized Clinical Trial (RCT) Out Group | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 12.5 | 59.6 years STANDARD_DEVIATION 13.6 | 58.7 years STANDARD_DEVIATION 13.4 |
| Asthma duration | 25.6 years STANDARD_DEVIATION 16.6 | 22.9 years STANDARD_DEVIATION 18.9 | 23.8 years STANDARD_DEVIATION 18.5 |
| Atopy | 19 participants | 55 participants | 74 participants |
| Daily dose of inhaled corticosteroid | 1590 microgram STANDARD_DEVIATION 419 | 1477 microgram STANDARD_DEVIATION 576 | 1505 microgram STANDARD_DEVIATION 548 |
| Forced expiratory volume in one second (FEV1) pre bronchodilator (BD) | 1.63 Litres STANDARD_DEVIATION 0.54 | 1.81 Litres STANDARD_DEVIATION 0.86 | 1.73 Litres STANDARD_DEVIATION 0.76 |
| Number of exacerbations in the year preceding the prescription of anti IL-5 | 3.1 exacerbations STANDARD_DEVIATION 2.5 | 3.5 exacerbations STANDARD_DEVIATION 0.9 | 3.4 exacerbations STANDARD_DEVIATION 2.1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 22 participants | 86 participants | 108 participants |
| Sex: Female, Male Female | 13 Participants | 51 Participants | 64 Participants |
| Sex: Female, Male Male | 9 Participants | 35 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Remission Rate With IL5/IL5R Antagonist
Percentage of subjects achieving asthma remission. Clinical remission on treatment at one year was defined as no asthma exacerbation, no treatment with oral corticosteroid and a less than 10% decrease in pre-bronchodilator FEV1 compared with baseline value.
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Clinical Trial (RCT) In Group | Remission Rate With IL5/IL5R Antagonist | 45 Percent |
| Randomized Clinical Trial (RCT) Out Group | Remission Rate With IL5/IL5R Antagonist | 24.4 Percent |
Primary
Response to IL5/IL5R Antagonist
Percentage of subjects achieving response to IL5/IL5R antagonists. A response to treatment was defined as a reduction of asthma exacerbations of at least 50% or a 50% or higher reduction of the OCS doses for steroid dependant patients in the year following the initiation of an IL5/IL5R antagonist compared to the year preceding the initiation of the treatment.
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Randomized Clinical Trial (RCT) In Group | Response to IL5/IL5R Antagonist | 76.5 Percent |
| Randomized Clinical Trial (RCT) Out Group | Response to IL5/IL5R Antagonist | 82.5 Percent |