PROTECT YOUR SEA PATIENTS FROM EXACERBATIONS WITH NUCALA

Exacerbation reduction data from a clinical trial and real-world study

Exacerbation reduction

Trial 2 (32 Weeks):

53 percent reduction 53 percent reduction

in exacerbations/year with NUCALA + SOC (n=194) vs placebo + SOC (n=191) (0.83 vs 1.74, P<0.001), primary endpoint.1

Trial 2 study design

Real-world study (total population): 71% reduction with NUCALA (1-year post-exposure, N=820) vs pre-NUCALA (1-year pre-exposure, N=821), 1.24 vs 4.29, RR: 0.29 (95% CI: 0.26, 0.32), primary objective. Results are descriptive.2

REAL-WORLD STUDY:
EXACERBATION REDUCTION SUSTAINED OVER 2 YEARS3

Real world study: exacerbation reduction sustained over 2 years

Secondary objective. Results are descriptive.

Real world study: exacerbation reduction sustained over 2 years

Secondary objective. Results are descriptive.

Real-world study limitations: Single-arm, prospective, observational cohort study.

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

REAL-WORLD STUDY. REAL-WORLD PATIENTS. GET TO KNOW REALITI-A.

Real-world study design

Patients with zero exacerbations

Trial 2: Patients with zero exacerbations at Week 32: 67% with NUCALA (130/194) vs 45% with placebo (86/191). Results are descriptive.2

Trial 2 study design

REAL-WORLD STUDY:
ZERO EXACERBATIONS OVER 2 YEARS3

Real-world study: zero exacerbations over 2 years

Results are descriptive.

Real-world study: zero exacerbations over 2 years

Results are descriptive.

Real-world study limitations: Single-arm, prospective, observational cohort study.

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

Real-world study design

Exacerbations across baseline EOS levels2

SUBGROUP ANALYSIS: REAL-WORLD STUDY (1-YEAR ANALYSIS) EXACERBATION RATES BY BASELINE BLOOD EOS LEVEL (CELLS/μL)2*

Subgroup analysis: real-world study (1-year analysis) exacerbation rates by baseline blood EOS level (cells/μL)
Subgroup analysis: real-world study (1-year analysis) exacerbation rates by baseline blood EOS level (cells/μL)

 

Pre-NUCALA (1-year pre-exposure)

 

NUCALA (1-year post-exposure)

Real-world study subgroup analysis by baseline blood EOS level <150 cells/µL: 65% reduction with NUCALA (n=98) vs pre-NUCALA (n=98), 1.46, 4.16, RR: 0.35 (95% CI: 0.27, 0.46).2

Post hoc analysis. All results are descriptive.

Real-world study limitations: Single-arm, prospective, observational cohort study.

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

*614 patients had analyzable data for baseline blood EOS levels within 90 days of starting NUCALA. Results from final data delivered after 2 years.2

Real-world study design 

Lung function

Trials 2 and 3: Numerical improvements in lung function were observed. Difference in mean change from baseline in FEV1 at end of treatment (95% CI) with NUCALA vs placebo: Trial 2, 98 mL (11, 184) at Week 32; Trial 3, 114 mL (-42, 271) at Week 24. Improvements were not consistent.

Results are descriptive.

Trial 2 study design

Trial 3 study design

REAL-WORLD STUDY: LUNG FUNCTION3

142 mL

INCREASE

from baseline pre-bronchodilator FEV1

Mean change from baseline (95% CI) at 2 years: 142 mL (53, 231), n=165.*
LS mean (95% CI): 2108 mL (2014, 2202) with NUCALA (2-years post-exposure, n=165)* vs 1966 mL (1890, 2042) at baseline (pre-NUCALA, n=398).

Other objective. Results are descriptive.

Real-world study limitations: Single-arm, prospective, observational cohort study.

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

*Number of participants with clinic FEV1 value within 90 days of time point.

Real-world study design 

CI=confidence interval; EOS=eosinophils; FEV1=forced expiratory volume in 1 second; OCS=oral corticosteroid; RR=rate ratio.

Learn about NUCALA and daily OCS use

SEE OCS DATA