01

Consistent asthma exacerbation rate data at blood eosinophil counts ≥300 cells/μL and ≥150 cells/μL1-3,5

In SIROCCO and CALIMA, FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-acting ß2-agonist) with or without other controllers, including systemic steroids. The primary endpoint for SIROCCO and CALIMA was the rate of asthma exacerbations in patients with baseline blood eosinophil count ≥300 cells/μL who were taking high-dose ICS and LABA.3

In ANDHI, FASENRA and placebo were administered plus SOC, which is defined as high-dose ICS plus another asthma controller, including OCS. The primary endpoint was annualized asthma exacerbation rate.6

FOOTNOTES

*Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.1,2,5

Asthma Exacerbation Rate in SIROCCO SIROCCO_CALIMA and BORA
Asthma Exacerbation Rate in SIROCCO SIROCCO_CALIMA and BORA

AER* with FASENRA + SOC (n=239) was 0.73 vs 1.01 with placebo + SOC (n=248) in CALIMA (56 weeks; P=0.019)2,3

02

Sustained exacerbation rate reduction data from baseline in years 1 and 2*6

in patients who continued on FASENRA Q8W from SIROCCO and CALIMA into BORA.

FOOTNOTES

*Patients who had baseline blood eosinophil count ≥300 cells/μL, receiving high-dose ICS/LABA, and who received FASENRA 30 mg Q8W during SIROCCO, CALIMA, and BORA.6

Annual exacerbation rate (AER) was defined as the total number of exacerbations multiplied by 365.25, divided by the total duration of follow-up (days) within the treatment group.1,2

Exacerbation rate over the year before pivotal study entry.6

Annual Exacerbation Rate
Annual Exacerbation Rate

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

03

FASENRA is the ONLY anti-eosinophil to show lung function improvement, sustained over 2 years*†1-4,6,7

Impact on lung function over 2 years with FASENRA compared to baseline FEV1*3,6,7

FOOTNOTES

*Pooled analysis of adult (treated with high-dose ICS/LABA) and adolescent (treated with medium- to high-dose ICS/LABA) patients with severe asthma and baseline blood eosinophil count ≥300 cells/μL in SIROCCO and CALIMA randomized to treatment with FASENRA 30 mg SC Q8W. BORA Week 56 results are adults only.6

Statistical significance for FEV1 improvement was established at end of treatment. Week 4 results were descriptive only. FASENRA demonstrated greater improvements in change from baseline in pre-bronchodilator FEV1 compared with placebo at Week 4 (first measured time point after administration of treatment dose) that were maintained through end of treatment in SIROCCO and CALIMA.1,2,4

End of treatment (EOT) pooled results from Week 48 for SIROCCO and Week 56 for CALIMA.6

Impact on lung function over 2 years with FASENRA compared to baseline FEV1
Impact on lung function over 2 years with FASENRA compared to baseline FEV1

FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus.

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

In SIROCCO, significant improvement in FEV1 was 398 mL with FASENRA + SOC (n=264) compared to 239 mL with placebo + SOC (n=261) at Week 48 (P=0 .0006).1,3 In CALIMA, significant improvement in FEV1 for FASENRA + SOC (330 mL; n=238) was 116 mL greater than placebo + SOC (215 mL; n=244) at Week 56, with FASENRA + SOC showing a 19% improvement from mean baseline FEV1 of 1 .76 L (P=0 .010).2,3 At Week 4, improvement in FEV1 was 290 mL with FASENRA + SOC (n=251) compared to 209 mL with placebo + SOC (n=249) in SIROCCO (48 weeks).†,4

04

Reduction in rescue medication use observed as early as day 38

32% greater reduction in mean rescue medication use at end of treatment for FASENRA (-2.93 puffs/day; n=500) compared to placebo + SOC (-2.23 puffs/day; n=514)*8

FOOTNOTE

*Results from a post hoc, pooled analysis of patients from SIROCCO and CALIMA with baseline blood eosinophil counts ≥300 cell/µL who received FASENRA 30 mg SC every 8 weeks or placebo. Mean baseline rescue medication use was 4.4 puff/day for FASENRA and 5.1 puffs/day for placebo. Reductions are least-squares mean changes from baseline.8

78% greater reduction in mean rescue medication use at Day 3 in patients who received FASENRA + SOC8

(-0.89 puffs/day; n=486) compared to placebo + SOC (-0.50 puffs/day; n=498)*8

The analyses of these endpoints were not multiplicity protected. Results are descriptive only.

Protection From Systemic Corticosteroid Exposure

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

Dosing                    


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Study
Designs

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IMPORTANT SAFETY INFORMATION