EXACERBATION DATA IN SEA PATIENTS WITH COMORBIDITIES

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

61% reduction in exacerbations/year requiring hospitalization/ED visit (0.08 vs 0.20, P=0.02), secondary endpoint.1

Trial 2 study design

Real-world study (REALITI-A) (total population, N=822): 71% reduction in exacerbations/year with NUCALA (1-year post-exposure) vs pre-NUCALA (1-year pre-exposure), 1.24 vs 4.29, rate ratio: 0.29 (99% CI: 0.26, 0.32), primary objective.2 Results are descriptive.

Real-world study design

Real-world exacerbation reduction data in SEA patients with allergic characteristics

A real-world study evaluated reduction in asthma exacerbations in a large, diverse population with baseline characteristics including2,3:

Total IgE levels

Allergic status

FeNO levels

REALITI-A study design

SEA with allergic characteristics: real-world exacerbation data

Exacerbations across total IgE levels

SUBGROUP ANALYSIS: REAL-WORLD STUDY (1-YEAR INTERIM ANALYSIS) EXACERBATION RATES BY BASELINE TOTAL IgE2*

Subgroup analysis: real-world study (1-year interim analysis) exacerbation rates by baseline total IgE
Subgroup analysis: real-world study (1-year interim analysis) exacerbation rates by baseline total IgE

Post hoc analysis. Results are descriptive.

Pre-NUCALA (1-year pre-exposure)

NUCALA (1-year post-exposure)

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

*674 patients had analyzable data for baseline total IgE levels within 90 days of starting NUCALA.2

Real-world study design

Exacerbations by baseline allergic status

SUBGROUP ANALYSIS: REAL-WORLD STUDY
(1-YEAR INTERIM ANALYSIS)
EXACERBATION RATES BY ALLERGIC STATUS2*†

Subgroup analysis: real-world study (1-year interim analysis) exacerbation rates by allergic status

Post hoc analysis. Results are descriptive.

Pre-NUCALA (1-year pre-exposure)

NUCALA (1-year post-exposure)

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

*472 patients had analyzable data for assessment of baseline allergic status.2
†Allergic (atopic) status was determined by a positive skin prick test or positive RAST score ≥1 (≥0.35 kU/L) for ≥1 specific IgE allergen.2

Real-world study design

Exacerbations by baseline FeNO level

SUBGROUP ANALYSIS: REAL-WORLD STUDY (1-YEAR INTERIM ANALYSIS) EXACERBATION RATES BY BASELINE FeNO LEVEL2*

Subgroup analysis: real-world study (1-year interim analysis) exacerbation rates by baseline FeNO level

Post hoc analysis. Results are descriptive.

Pre-NUCALA (1-year pre-exposure)

NUCALA (1-year post-exposure)

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

*360 patients had analyzable data for baseline FeNO levels within 90 days of starting NUCALA.2

Real-world study design

Exacerbations requiring hospitalization

Trial 2: 69% reduction in exacerbations requiring hospitalization with NUCALA vs placebo, 0.03 vs 0.10, rate ratio: 0.31 (95% CI: 0.11, 0.91).1 Results are descriptive.

Real-world study (REALITI-A): 69% reduction in exacerbations requiring hospitalization with NUCALA (1-year post-exposure, N=820) vs pre-NUCALA (1-year pre-exposure, N=821), 0.14 vs 0.45, rate ratio: 0.31 (95% CI: 0.24, 0.39), secondary objective. 91% had zero exacerbations requiring hospitalization with NUCALA vs 76% pre-NUCALA.2 All results are descriptive.

Exacerbations requiring hospitalization in subgroup with comorbid nasal polyps*

95 percent

of patients had ZERO EXACERBATIONS requiring hospitalization with NUCALA vs 82% pre-NUCALA2

89% of patients had zero exacerbations with NUCALA vs 73% pre-NUCALA.2

Post-hoc analysis. Results are descriptive.

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

*Nasal polyps reported as past medical condition at baseline.

Real-world study design

CI=confidence interval; FeNO=fractional exhaled nitric oxide; IgE=immunoglobulin E; RAST=radioallergosorbent test; SOC=standard of care.

Explore the well-established safety profile

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