THE BIOLOGIC STUDIED ACROSS THE WIDE SPECTRUM* OF COPD PATIENTS WITH AN EOS PHENOTYPE 

PATIENT CHARACTERISTICS

MATINEE + METREX:

GOLD 2-41-3*

  • GOLD 2: 39%
  • GOLD 3: 45%
  • GOLD 4: 15%

mMRC grades1,4*†

  • Grade <2: 22%
  • Grade ≥2: 78%

With or without chronic bronchitis1,4*

  • Presence: 65%
  • Absence: 33%

METREX:

BEC4*

  • ≥150 cells/µL at screening: 97%
  • ≥300 cells/µL in past year: 3%

Smoking status3*

  • Current smoker‡: 29%
  • Former smoker‡: 67%
  • Never smoked: 4%

*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).3,4
†The mMRC dyspnea scale ranges from grade 0 to 4, with higher grades indicating more severe dyspnea.2,5
‡≥10 pack-years.3

BEC=blood eosinophil count; EOS=eosinophilic; FEV1=forced expiratory volume in 1 second; GOLD=Global Initiative for Chronic Obstructive Lung Disease; mMRC=modified Medical Research Council; SGRQ-C=St. George’s Respiratory Questionnaire for COPD.

MATINEE: 52-104 week pivotal study

  • MATINEE TRIAL1

    MATINEE study design: 52-104 week pivotal study MATINEE study design: 52-104 week pivotal study

    Study description1: 52- to 104-week multicenter, randomized, double-blind, pivotal trial evaluating NUCALA 100 mg SC every 4 weeks vs placebo, each added to SOC,* in 804 patients ≥40 years old with COPD with an EOS phenotype (defined as BEC ≥300 cells/µL at screening), a history of exacerbations (≥2 moderate or ≥1 severe)§ in past year, moderate to very severe airflow limitation,|| and current/former smoking status.Patients with a past or present asthma diagnosis were excluded.

    Primary endpoint1: Annualized rate of overall moderate/severe exacerbations at Weeks 52-104.

    MATINEE SELECT BASELINE CHARACTERISTICS#

    MATINEE select baseline characteristics MATINEE select baseline characteristics
    *ICS + LABA + LAMA.
    †345 patients received NUCALA + SOC (n=170) or placebo + SOC (n=175) who participated for a fixed duration (52 weeks).1
    ‡459 patients received NUCALA + SOC (n=233) or placebo + SOC (n=226) who participated for a variable duration (up to 104 weeks).1
    §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.4
    ||Post-bronchodilator FEV1/FVC ratio of <0.7 and FEV1 of 20-80% predicted.
    ≥10 pack-years.1
    #Data are mean values unless otherwise stated.1
    **mITT included all randomized patients who received ≥1 dose of study drug, with analysis according to randomized treatment group.1
    ††mMRC data missing for 6 patients (<1%).1
    ‡‡Data missing for 21 patients (3%).1
    §§SGRQ total score, as based on the SGRQ-COPD questionnaire: scores range 0-100 points; higher scores indicate worse health status.1
    BEC=blood eosinophil count; CI=confidence interval; EOS=eosinophilic; FEV1=forced expiratory volume in 1 second; FVC=forced vital capacity; ICS=inhaled corticosteroid; LABA=long-acting beta2-agonist; LAMA=long-acting muscarinic antagonist; mITT=modified intention-to-treat; mMRC=modified Medical Research Council; SC=subcutaneous; SD=standard deviation; SGRQ=St. George’s Respiratory Questionnaire; SOC=standard of care.

METREX: 52-week pivotal study

  • METREX TRIAL3

    METREX study design: 52-week pivotal study METREX study design: 52-week pivotal study

    Study description3: 52-week multicenter, randomized, double-blind, pivotal trial study evaluating NUCALA 100 mg SC every 4 weeks vs placebo, each added to SOC,* in 836 patients ≥40 years old with COPD with an EOS phenotype, a history of exacerbations (≥2 moderate or ≥1 severe)† in past year, and moderate to very severe airflow limitation.‡ Patients were stratified by BEC with the efficacy population (EOS phenotype, n=462) defined as ≥150 cells/μL at screening or ≥300 cells/μL in past year. There was insufficient data to support the efficacy of NUCALA in patients with BEC <150 cells/µL at screening with no evidence of ≥300 cells/µL in past year. Patients with present asthma diagnosis (smokers/former smokers)§ and history of asthma (never smokers) were excluded.

    Primary endpoint3: Annualized rate of moderate or severe exacerbations at Week 52.

    SELECT BASELINE CHARACTERISTICS OF EFFICACY POPULATION IN METREXll

    METREX select baseline characteristics METREX select baseline characteristics
    *ICS + LABA + LAMA.
    †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.4
    ‡Post-bronchodilator FEV1/FVC ratio <0.7 and FEV1 of 20-80% predicted.
    §≥10 pack-years.3
    llData are mean values unless otherwise stated.
    Defined as ≥150 cells/µL at screening or ≥300 cells/µL in past year.3
    #Data missing for 11 patients (2%).4
    **SGRQ total score, as based on the SGRQ-COPD questionnaire: scores range 0-100 points; higher scores indicate worse health status.3
    BEC=blood eosinophil count; CI=confidence interval; EOS=eosinophilic; FEV1=forced expiratory volume in 1 second; FVC=forced vital capacity; ICS=inhaled corticosteroid; LABA=long-acting beta2-agonist; LAMA=long-acting muscarinic antagonist; mMRC=modified Medical Research Council; SC=subcutaneous; SD=standard deviation; SGRQ=St. George's Respiratory Questionnaire; SOC=standard of care.
COPD patient Nicholas throwing a Frisbee in an outdoor pool COPD patient Nicholas throwing a Frisbee in an outdoor pool

YOU MAY KNOW PATIENTS LIKE NICHOLAS IN YOUR PRACTICE

GO TO PATIENT PROFILES
Woman shaking hands with man at outdoor farmers market Woman shaking hands with man at outdoor farmers market

EXPLORE NUCALA DATA IN COPD PATIENTS WITH AN EOSINOPHILIC PHENOTYPE

VIEW NUCALA EFFICACY