Effectiveness of Anti-IL-5/IL5R Inhibitors

NCT06239441 | Completed Results

• 1 other identifier: 2021-2190
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Asthma

Keywords

Severe Asthma; IL5 antagonist

Outcome Measures

Primary Outcomes (2)

• 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.

  one year

• 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.

  one year

Interventions

IL5/IL5R Antagonists DRUG

Treatment with IL5/IL5R antagonists for one year

Also known as: mepolizumab, benralizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years and older diagnosed with severe asthma in whom an IL5/IL5R antagonist was initiated between 2012 and 2020 for were included. 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).

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, HJ1C5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

mepolizumab; benralizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Catherine Lemiere
• Organization: Hôpital du Sacre Coeur de Montreal

catherine.lemiere@umontreal.ca

514 338 2492

Study Officials

• Catherine Lemiere, MD

  Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: February 16, 2021
• Primary Completion: June 13, 2023
• Study Completion: November 29, 2023
• Last Updated: October 28, 2024
• Results First Posted: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)