TRIAL RESULTS

NUCALA reduced exacerbations* with data up to 2 years1

NUCALA helped prevent exacerbations* in a patient population with a wide spectrum† of COPD and an EOS phenotype1

21% significant reduction in overall moderate or severe exacerbations per year with NUCALA vs placebo 21% significant reduction in overall moderate or severe exacerbations per year with NUCALA vs placebo

MATINEE: NUCALA + SOC,‡ 0.80/year (n=403), vs placebo + SOC,‡ 1.01/year (n=401) at Weeks 52-104 (RR: 0.79; P=0.01),§ primary endpoint.1

METREX: 18% reduction of moderate or severe exacerbations* at Week 52 for NUCALA + SOC,‡ 1.40/year (n=233) vs placebo + SOC,‡ 1.71/year (n=229). RR: 0.82 (P=0.04),§ primary endpoint.2

*Moderate exacerbations defined as exacerbations (worsening of COPD symptoms) requiring treatment with systemic corticosteroids and/or antibiotics. Severe exacerbations defined as those requiring hospitalization (≥24 hours) or resulting in death.3
†In patients (receiving NUCALA or placebo) with analyzable data for assessment at baseline: For the overall population in MATINEE and the efficacy population in METREX, airflow obstruction severity (GOLD grade) by FEV1 % predicted (GOLD 2 [≥50–<80%], GOLD 3 [≥30–<50%], GOLD 4 [<30%]), mMRC dyspnea score|| (Grade <2, Grade ≥2), and chronic bronchitis symptoms assessed by SGRQ-C (presence and absence).1-4 For the efficacy population in METREX, BEC (≥150 cells/µL at screening or ≥300 cells/µL in past year), and smoking status (current, former, never).2,3
‡SOC=triple inhaled therapy (ICS + LABA + LAMA).
§Mean rate of exacerbations in previous year: MATINEE 2.3; METREX 2.5.1,2
||The mMRC dyspnea scale ranges from grade 0 to 4, with higher grades indicating more severe dyspnea.4,5

MATINEE/METREX study designs

The only biologic studied for 2 years to help reduce hospital visits* due to exacerbations1

35% reduction in exacerbations requiring hospitalization and/or ED visit per year with NUCALA vs placebo 35% reduction in exacerbations requiring hospitalization and/or ED visit per year with NUCALA vs placebo

MATINEE: NUCALA + SOC,† 0.13/year (n=403) vs placebo + SOC,† 0.20/year (n=401) at Weeks 52-104; RR: 0.65 (95% CI: 0.43, 0.96).

Secondary endpoint; not statistically significant due to failure earlier in the testing hierarchy.

*Hospitalizations/ED visits of any length.
†SOC=triple inhaled therapy (ICS + LABA + LAMA).

MATINEE/METREX study designs

Change in quality of life, based on SGRQ total score*

SGRQ CHANGE FROM BASELINE AT WEEK 52 IN MATINEE1,3

MATINEE: 50% of patients had a clinically important difference in SGRQ on NUCALA vs 46% on placebo at Week 52 MATINEE: 50% of patients had a clinically important difference in SGRQ on NUCALA vs 46% on placebo at Week 52
Results are descriptive.

MATINEE: 50% of patients had a clinically important difference in SGRQ* on NUCALA (n=390) vs 46% on placebo (n=393) at Week 52. OR: 1.17 (95% CI: 0.87, 1.57).1,3

METREX: 42% of patients had a clinically important difference in SGRQ* on NUCALA (n=228) vs 40% on placebo (n=223) at Week 52. OR: 1.08 (95% CI: 0.74, 1.59).2

All results are descriptive.

SGRQ MEASURES6,7:
Respiratory symptoms
Activity disruption
Psychosocial impact
*SGRQ scores calculated from SGRQ-COPD questionnaire: scores range from 0-100 points; higher scores indicate worse health status. A clinically important difference is defined as a reduction in score of ≥4 points.1,7

MATINEE/METREX study designs

BEC=blood eosinophil count; CI=confidence interval; ED=emergency department; EOS=eosinophilic; FEV1=forced expiratory volume in 1 second; GOLD=Global Initiative for Chronic Obstructive Lung Disease; ICS=inhaled corticosteroid; LABA=long-acting beta2-agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; mMRC=modified Medical Research Council; OR=odds ratio; RR=rate ratio; SC=subcutaneous; SD=standard deviation; SGRQ=St. George’s Respiratory Questionnaire; SGRQ-C=St. George’s Respiratory Questionnaire for COPD; SOC=standard of care.

NUCALA has a well-established safety profile based on 3 phase 3 trials

REVIEW SAFETY DATA