Safety
Profile

Explore the adverse event profiles of FASENRA.

01

Adverse event profile similar to placebo in Year 1, maintained in Year 21,2

*Pharyngitis was defined as follows: pharyngitis, pharyngitis bacterial, viral pharyngitis, and pharyngitis streptococcal.

Hypersensitivity reactions were defined as follows: urticaria, urticaria papular, and rash.

Adverse event profile comparable to placebo was observed in 3 clinical trials1

Adverse Reactions in SIROCCO, CALIMA and ZONDA
Adverse Reactions in SIROCCO, CALIMA and ZONDA
FOOTNOTES

*Pharyngitis was defined as follows: pharyngitis, pharyngitis bacterial, viral pharyngitis, and pharyngitis streptococcal.

Hypersensitivity reactions were defined as follows: urticaria, urticaria papular, and rash.

02

Adverse Event Profile: BORA

In BORA, FASENRA given for an additional 56 weeks showed a similar adverse event profile to that observed in SIROCCO and CALIMA2

2 Years
2 Years

In BORA, the primary endpoint was to assess the safety and tolerability of the 2 dosing regimens of FASENRA. Patients who received FASENRA during SIROCCO and CALIMA continued to receive their randomized dose. Patients who received placebo were re-randomized to receive 1 of 2 doses of FASENRA at the beginning of BORA.2

03

Injection Site Reactions

SIROCCO AND CALIMA1

Injection site reactions with FASENRA were similar to placebo: 2.2% vs 1.9%, respectively.1

BORA2

Injection site reactions were 2% for patients who continued on FASENRA Q8W dosing from SIROCCO or CALIMA into BORA (n=512) vs 1% for patients who received placebo in SIROCCO or CALIMA and then received FASENRA Q8W* in BORA (n=281).2

*First 3 doses given Q4W

 

Overall, treatment-emergent anti-drug antibody response developed in 13% of patients treated with FASENRA at the recommended dosing regimen during the 48- to 56-week treatment period. A total of 12% of patients treated with FASENRA developed neutralizing antibodies. Anti-benralizumab antibodies were associated with increased clearance of benralizumab and increased blood eosinophil levels in patients with high anti-drug antibody titers compared to antibody-negative patients. No evidence of an association of anti-drug antibodies with efficacy or safety was observed.1

Power to Prevent Exacerbations

Learn more about the efficacy of FASENRA in relation to exacerbation and lung function data.

Protection From Systemic Corticosteroid Exposure

Learn more about how FASENRA can provide protection from exacerbations requiring steroids and dependence on OCS.

Study
Designs

See full study descriptions for SIROCCO, CALIMA, BORA, ANDHI, and more.

IMPORTANT SAFETY INFORMATION