FASENRA▼ benralizumab

FASENRA is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.1

Efficacy

FASENRA reduces exacerbations in those patients with ≥2 exacerbations in the previous 12 months5

SIROCCO primary endpoint: reductions in AER at 48 weeks in patients with blood eosinophils ≥300 cells/μL and ≥2 exacerbations in prior year5

SIROCCO Data
SIROCCO Data

 

*The analysis of this endpoint was not multiplicity protected. Therefore, p value is reported as nominal. Results are descriptive only.

CALIMA primary endpoint: reductions in AER at 56 weeks in patients with blood eosinophils ≥300 cells/μL and ≥2 exacerbations in prior year9

CALIMA  Data
CALIMA  Data

 

 

  • FASENRA  reduced annual exacerbation rate vs placebo in SIROCCO by 51% (0.65 vs 1.33; p<0.0001) and CALIMA by 28% (0.66 vs 0.93; p=0.0188).5,9
  • Time to first exacerbation (secondary endpoint) was delayed in patients receiving FASENRA vs placebo in SIROCCO (HR 0.60 [95% CI 0.46, 0.78]; p=0.0002) and CALIMA (HR 0.73 [95% CI0.55, 0.95], p=0.0182).5,9
  • Fasenra should not be used to treat acute asthma exacerbations1

*Despite similar trial designs, reductions in exacerbation rates seemed to be greater in SIROCCO than CALIMA. Subgroup analyses suggested three key drivers: regional effect, exacerbation history and placebo response.9

The analysis of this endpoint was not multiplicity protected. Therefore, p value is reported as nominal. Results are descriptive only.

Fasenra significantly reduced median daily OCS dose by 75% vs 25% with placebo7

ZONDA primary endpoint: reduction from baseline in median daily OCS dose at week 28 in chronic OCS patients7

Zonda data 1
Zonda data 1


75% REDUCTION

VS 25% REDUCTION IN MEDIAN DAILY OCS DOSE WITH PLACEBO
FASENRA (n=73) Placebo (n=75)
p<0.0017

ZONDA secondary endpoint:
exacerbation and hospitalisation/ER
visit rate at week 28 in
chronic OCS users7

 Zonda data 2
 Zonda data 2


70% REDUCTION
IN AER vs PLACEBO (0.54 vs 1.83)
FASENRA (n=73) Placebo (n=75)
p<0.001*

Zonda data 3
Zonda data 3


93% REDUCTION

IN EXACERBATIONS LEADING TO HOSPITALISATIONS/ER VISITS vs PLACEBO (0.02 vs 0.32)
FASENRA (n=73) Placebo (n=75)
p=0.02*

  • 52% of patients originally dosed with ≤  12.5mg prednisone/prednisolone at the end of the study run-in phase and who received Fasenra eliminated OCS use compared with 19% of patients with placebo (odds ratio [95% CI], 4.19 [1.58 - 11.12]; Fasenra n=42, Placebo n=42; p=0.002).7

ZONDA: patients had blood eosinophil counts ≥150 cells/μL, a history of at least one exacerbation in the past 12 months and were being treated with daily OCS (7.5–40 mg per day with a median dose of 10 mg).1,7

Primary endpoint was the reduction in OCS dose from baseline to week 28, while asthma control was maintained.7Percentage of patients that eliminated OCS use, AER and exacerbations leading to hospitalisations/ER visits were secondary endpoints.7

*The analyses of these endpoints were not multiplicity protected. Therefore, p values are reported as nominal. Results are descriptive only.

FASENRA improved FEV1 as early as 4 weeks vs placebo, with improvements maintained to study end5,11

SIROCCO secondary endpoint: pre-bronchodilator FEV1: FASENRA vs placebo5,11

 

SIROCCO:

  • FASENRA delivered an improvement in FEV1 of 290 mL (mean change from baseline) at 4 weeks, compared with 209 mL for placebo (p=0.039*)11
  • At 48 weeks, an improvement in FEV1 of 398 mL (mean change from baseline) was reported for FASENRA, compared with 239 mL for placebo (p=0.001)5,11

CALIMA secondary endpoint: pre-bronchodilator FEV1: FASENRA vs placebo9,12

 

CALIMA:

  • FASENRA delivered an improvement in FEV1 of 280 mL (mean change from baseline) at 4 weeks, compared with 152mL for placebo (p=0.002*)12
  • At 56 weeks, an improvement in FEV1 of 330 mL (mean change from baseline) was reported for FASENRA, compared with 215 mL for placebo (p=0.0102)9,12

Note: The benefits observed with FASENRA were additional to those seen with high dosage ICS+LABA and extra controller.5,9

FEV1 was a secondary endpoint.5,9 Primary endpoint was AER vs placebo in patients with blood eosinophils ≥300 cells/μL and ≥2 exacerbations in prior year.5,9

*The analyses of these endpoints were not multiplicity protected. Therefore, p value is reported as nominal. Results are descriptive only.

FASENRA offers improvements in asthma control, symptoms and QoL5,9

FASENRA improved patient-reported outcomes (secondary endpoints) in SIROCCO and CALIMA1,5,9

AQLQ data
AQLQ data

 

Data shown above were secondary endpoints.5,9 Primary endpoint was AER vs placebo in patients with blood eosinophils ≥300 cells/μL and ≥2 exacerbations in prior year. 5,9

The analyses of these endpoints were not multiplicity protected. p values are reported as nominal. Results are descriptive only.

Based on  8-weekly dosing schedule.*ACQ-6 = asthma control Questionnaire. A decrease in score indicates an improvement. n = 263. MCID : 0.5.5,13
TASS=Total Asthma Symptom Score. A decrease in score indicates an improvement. n = 263. MCID : 0.31.5,14
AQLQ=Standardised Asthma Quality of Life Questionnaire for 12 years and older. An increase in score indicates better quality of life. MCID : 0.5.5,15