Effectiveness of Anti-IL-5/IL5R Inhibitors

Severe Asthma Clinical Trial

Official title:

Assessment and Prediction of the Effectiveness of Mepolizumab Anti-IL-5/IL5R Inhibitors in a Real-world Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06239441
• Other study ID #: 2021-2190
• Status: Completed
• Start date: February 16, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: January 2024
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Objectives: 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.

After having obtained authorization from the ethics committee of the CIUSSS du nord de l'île de Montréal and from the director of the Professional Services, all the charts of patients who received anti IL5/IL-5R at the tertiary asthma clinic of the Hôpital du Sacré-Coeur de Montréal between 2012 and 2020 were reviewed.

Population Patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonist was initiated between 2012 and 2020 for the first time were included. If a patient had been treated with more than one IL5/IL5R antagonist during the study period, only the first biologic agent received was considered. Data recorded in the year preceding the initiation of IL5/IL5R antagonist were compared with data recorded in the year following the initiation of the biological therapy.

Subjects who were aged 75 years or younger, had a smoking history of less than 10 pack-year, a FEV1 of less than 80% of the predicted value along with FEV1 reversibility of at least 12% and 200 ml in the previous year were considered as fulfilling the inclusion criteria of the original RCTs (RCT in group). Subjects who did not meet one of those criteria were considered as not fulfilling the original RCT inclusion criteria (RCT out group).

Primary outcomes were the response to IL5/IL5R antagonists as well as the remission rate one year after CE in the whole population as well as among RCT in group and RCT out group.

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.

Asthma exacerbations were defined as short treatment of systemic corticosteroids (less than 14 days), a visit to the emergency department or an hospitalization related to asthma.

Clinical remission on treatment at one year post cohort entry was defined as no asthma exacerbation, no treatment with OCS and a less than 10% decrease in pre-bronchodilator FEV1 compared with baseline value.

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 performed to identify factors associated with a positive response to treatment as well as the achievement of remission on treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 29, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Intervention

Drug:
• IL5/IL5R Antagonists
Treatment with IL5/IL5R antagonists for one year

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal	GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to IL5/IL5R antagonist	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.	one year
Primary	Remission rate with IL5/IL5R antagonist	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.	one year
Secondary	Response to IL5/IL5R antagonists one year after CE among subjects who did and did not fullfill the inclusion criteria of the original randomized control trials.	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.	one year
Secondary	Clinical remission of asthma after treatment with IL5/IL5R antagonists among subjects who did and did not fullfill the inclusion criteria of the original randomized control trials.	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.	one year