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FASENRA® is indicated as an add-on maintenance treatment of adult patients with severe eosinophilic asthma.
In patients with blood eosinophil counts of ≥300 cells/µL taking high-dose ICS + LABA...1,2*
Rate of clinically significant exacerbations at week 48 (1° endpoint)
Rate of exacerbations requiring hospitalization/ER visit at week 48 (2° endpoint)
Adapted from FASENRA® Product Monograph.
In patients with blood eosinophil counts of ≥300 cells/µL taking high-dose ICS + LABA...1†
Rate of clinically significant exacerbations at week 56 (1° endpoint)
Rate of exacerbations requiring hospitalization/ER visit at week 56 (2° endpoint)
Adapted from FASENRA® Product Monograph.
The data in this grey box is from an observational real-world programme composed of five studies conducted in Canada, UK, Italy, Portugal, and Spain. As a single-arm retrospective trial, the data should be interpreted cautiously, as it is not a randomized controlled trial or in the product monograph. The methodology may make it difficult to distinguish drug effects from the natural course of the disease or placebo effects.
At week 48:
This is a retrospective cohort study (N=1002). The results should be interpreted with caution, as they featured neither randomization nor blinding. Additionally, a measure of sample dispersion was unavailable. The study’s applicability to the Canadian healthcare system has not been fully established, as the data is sourced from retrospective observational data from five national studies: Canada (n=306), Italy (n=217), Portugal (n=74), Spain (n=204), and the UK (n=208).
Clinically significant exacerbation = Worsening of asthma leading to use of oral/systemic corticosteroids for ≥3 days, ER visit requiring oral/systemic corticosteroids, or hospitalization. For patients on maintenance OCS, a clinically significant exacerbation requiring OCS was defined as a temporary increase in stable oral/systemic corticosteroids for ≥3 days or a single depo-injectable dose.1
* SIROCCO: 48-week, phase 3, randomized, double-blind study in patients with severe, uncontrolled asthma taking high-dose ICS + LABA. The primary efficacy (ITT) population had blood eosinophil count ≥300 cells/µL.1
† CALIMA: 56-week, phase 3, randomized, double-blind study in patients with severe, uncontrolled asthma taking medium- or high-dose ICS + LABA. The primary efficacy (ITT) population had blood eosinophil count ≥300 cells/µL and was taking high-dose ICS.1
‡ A multinational, retrospective, observational study conducted to assess the real-world effectiveness of FASENRA®. 1002 patients with severe eosinophilic asthma were enrolled in the study and received a dose that is aligned to the Product Monograph. The study assessed annualized exacerbation rate, mOCS use, asthma symptom control, and lung function. Exacerbation was defined as worsening of asthma leading to one of the following: (1) use of systemic corticosteroid for ≥3 days or a temporary increase in a stable background dosage of OCS; (2) emergency department or urgent care visit (<24 hours) due to asthma that required systemic corticosteroid; or (3) inpatient admission to hospital (≥24 hours) due to asthma.
CI: confidence interval; ER: emergency room; ICS: inhaled corticosteroids; ITT: intent-to-treat; LABA: long-acting beta2-agonist; mOCS: maintenance oral corticosteroids; RR: rate ratio.
References:
Adapted from FASENRA® Product Monograph and Data on File.
Adapted from FASENRA® Product Monograph.
The data in this grey box is from an observational real-world programme composed of five studies conducted in Canada, UK, Italy, Portugal, and Spain. As a single-arm retrospective trial, the data should be interpreted cautiously, as it is not a randomized controlled trial or in the product monograph. The methodology may make it difficult to distinguish drug effects from the natural course of the disease or placebo effects.
This is a retrospective cohort study (N=1002). The results should be interpreted with caution, as they featured neither randomization nor blinding. Additionally, a measure of sample dispersion was unavailable. The sample size assessed for the FEV1 endpoint was limited to 263 patients. The study’s applicability to the Canadian healthcare system has not been fully established, as the data is sourced from retrospective observational data from five national studies: Canada (n=306), Italy (n=217), Portugal (n=74), Spain (n=204), and the UK (n=208).
* SIROCCO: 48-week, phase 3, randomized, double-blind study in patients with severe, uncontrolled asthma taking high-dose ICS + LABA. The primary efficacy (ITT) population had blood eosinophil count ≥300 cells/µL.1
† CALIMA: 56-week, phase 3, randomized, double-blind study in patients with severe, uncontrolled asthma taking medium- or high-dose ICS + LABA. The primary efficacy (ITT) population had blood eosinophil count ≥300 cells/µL and was taking high-dose ICS.1
‡ A multinational, retrospective, observational study conducted to assess the real-world effectiveness of FASENRA®. 1002 patients with severe eosinophilic asthma were enrolled in the study and received a dose that is aligned to the Product Monograph. The study assessed annualized exacerbation rate, mOCS use, asthma symptom control, and lung function. Exacerbation was defined as worsening of asthma leading to one of the following: (1) use of systemic corticosteroid for ≥3 days or a temporary increase in a stable background dosage of OCS; (2) emergency department or urgent care visit (<24 hours) due to asthma that required systemic corticosteroid; or (3) inpatient admission to hospital (≥24 hours) due to asthma.
FEV1: forced expiratory volume in 1 second; ICS: inhaled corticosteroids; ITT: intent-to-treat; LABA: long-acting beta2-agonist; LS: least-squares; mOCS: maintenance oral corticosteroids; SD: standard deviation.
References:
Adverse events with ≥1% incidence with FASENRA® and ≥1% more common with FASENRA® than placebo
In a select subset of patients who were tolerant to FASENRA® and entered the 56-week, single-blind, uncontrolled, extension trial (n=440), the safety profile of FASENRA® was consistent with that observed in placebo-controlled studies.1
Patients (n=226) transitioned to another extension study, MELTEMI, and were treated with FASENRA® every 8 weeks for up to 43 months.2
References:
FASENRA® and the AstraZeneca logo are registered trademarks of, and FASENRA PEN™ is a trademark of, AstraZeneca AB, used under license by AstraZeneca Canada Inc.
