Real World Evidence of Benralizumab in Eosinophilic Severe AsThma in Russia (BEST)

October 18, 2024 updated by: AstraZeneca

A Multicenter, Single Arm, Non-interventional, Observational, Prospective Study to Assess Demographic Characteristics, Burden of Disease and Short-term Patient Reported Outcomes on Symptom Relief in Severe Eosinophilic Asthma Patients Aged Older Than 18 Qualifying for Treatment With Benralizumab in Russia

Benralizumab is a humanised, afucosylated, monoclonal antibody against the interleukin (IL)-5 receptor (IL-5R) α subunit that induces direct, rapid, and near-complete depletion of eosinophils in blood, airway tissue, and bone marrow through enhanced antibody-dependent cell-mediated cytotoxicity (ADCC). This apoptotic process involves natural killer cells responsible for the controlled eosinophilic elimination. In the two pivotal phase III trials SIROCCO and CALIMA, benralizumab was well tolerated, significantly reduced asthma exacerbations by up to 51%, and improved lung function as well as disease control in patients with severe, uncontrolled asthma and blood eosinophil count of ≥ 300 cells/μL blood, receiving both ICS and LABA.

According to the summary of product's characteristics (SmPC) of benralizumab in Russia, it can be used for an add-on maintenance treatment for adult patients with severe eosinophilic asthma. All patients enrolled in the BEST study will comply with the SmPC approved by the Russian Ministry of Health.

Study Overview

Status

Completed

Conditions

Severe Eosinophilic Asthma

Detailed Description

This is a multicentre, single arm, non-interventional observational, prospective study that will include patients older than 18 years, who qualify for the treatment with benralizumab according to the SmPC in participating research centres (study cites) focusing on severe eosinophilic asthma in Russia. The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients who meet the study criteria will be enrolled and, as outlined in the current label of benralizumab approved by Russian Ministry of Health, are planned to receive 3 subcutaneously (s.c.) applied doses of 30 mg benralizumab, from weeks 0 (baseline) every 4 weeks and then every 8 week. A follow-up visit to assess the sustainability of achieved changes will be done after 56 weeks. No study drug will be provided, all patients will be on commercially available drug. Additional two study visits at week 1 and 2 can also be done remotely via phone calls to obtain the paper-based SGRQ, ACQ-5, PGI-C and PGI-S questionnaires.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Russian Federation
- - Moscow, Russian Federation, 105077
    - City clinical hospital No57

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

The study will recruit 59 male and female patients aged ≥ 18 years with severe, eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria (15% drop out). Approximately 10 centers across Russia will participate in the study. Only those centres that have experience with biologic treatment, can initiate treatment with benralizumab and have a good oversight on the severe asthma population (as in some settings the patients are referred for longer term stationary care to achieve asthma control) will be able to participate.

Description

Inclusion Criteria:

Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Russian label and in line with reimbursement condition must meet all the following criteria:

Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma.
Asthma requiring high-dose ICS plus LABA as maintenance treatment.
Minimum of 2 exacerbations in the last 12 months. Or 1 exacerbation in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day)
Documented peripheral blood eosinophil count ≥ 300 cells/μL or ≥150 cells/μL blood in case that patient had been receiving oral glucocorticoid therapy for at least 6 continuous months directly before enrollment (equivalent to a prednisolone or prednisone dose of 7.5 to 40.0 mg per day).
Provision of signed written ICF indicating that they understand the purpose of the study and procedures required for participation in the study.
Patients must be able and willing to read and comprehend written instructions and comprehend and complete the questionnaires required by the protocol (SGRQ, ACQ-5, PGIC and PGIS).

Exclusion Criteria:

Patients who have previously received benralizumab prior to the start of the study.

Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
Concomitant treatment with any other biologic for any indication or previous treatment with biology. Acceptable wash-out periods for other asthma biologics: ≥4 month or duration of 5 half-lives from last dose of previous biologic. We choose what is longer the 5 half-life or 4 months.
Currently enrolled in an interventional clinical study in parallel, except:
- Patients being in parallel documented in a national asthma registry.
- Patients having completed any other clinical trial including those with biologic treatment ≥4 month or duration of 5 half-lives from last dose of previous biologic. We choose what is longer the 5 half-life or 4 months.
An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the change in patient asthma control after initiation of benralizumab in a real-world Russian setting Time Frame: Up to 6 month	Mean scores change from baseline in Asthma Control Questionnaire-5 (ACQ-5) after 8 weeks of treatment with benralizumab.	Up to 6 month
To evaluate the change in respiratory health-related quality of life in a real-world Russian setting Time Frame: Up to 6 month	Total scores change from baseline in St. George's Respiratory Questionnaire (SGRQ) after 8 weeks of treatment with benralizumab	Up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

CSR Synopsis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Actual)

November 13, 2023

Study Completion (Actual)

November 13, 2023

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria