• Trial results
  • Study designs
  • Dosing & admi
  • Safety profile

Trial results

Trial results

Study designs

Dosing & admin

Safety profile

Trial results

Study designs

Dosing & admin

Safety profile

  • Trial results
  • Study designs
  • Dosing & admin
  • Safety profile

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% significant 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 scoreII (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

IIThe mMRC dyspnea scale ranges from grade 0 to 4, with higher grades indicating more severe dyspnea.4,5

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).1

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

*Hospitalizations/ED visits of any length.

The biologic studied across the wide spectrum* of COPD patients with an EOS phenotype

PATIENT CHARACTERISTICS

MATINEE + METREX:

GOLD 2-41,2,4*

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

mMRC
grades1,3*†

  • Grade <2: 22%
  • Grade ≥2: 78%

With or without chronic bronchitis1,3*

  • Presence: 65%
  • Absence: 33%

METREX:

BEC3*

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

Smoking status2*

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

MATINEE 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 and an eosinophilic phenotype (defined as BEC of ≥300 cells/µL at screening), a history of exacerbations (≥2 moderate or ≥1 severe) in past year, moderate to very severe airflow limitation,II and current/former smoking status.‡ Patients with a past or present asthma diagnosis were excluded.

2-YEAR MATINEE TRIAL: THE LONGEST PHASE 3 TRIAL OF ANY COPD BIOLOGIC1

2-year MATINEE trial: the longest Phase 3 trial of any COPD biologic
2-year MATINEE trial: the longest Phase 3 trial of any COPD biologic

STUDIED ADDITIONALLY IN THE METREX TRIAL

METREX study description2: 52-week multicenter, randomized, double-blind, pivotal trial evaluating NUCALA 100 mg SC every 4 weeks vs placebo, each added to SOC,§ in 836 patients ≥40 years old with COPD, a history of exacerbations (≥2 moderate or ≥1 severe) in past year, and moderate to very severe airflow limitation.ll 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.

METREX TRIAL2

METREX COPD trial
METREX COPD trial

*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

†The mMRC dyspnea scale ranges from Grade 0 to 4, with higher grades indicating more severe dyspnea.4,5

‡≥10 pack-years.1,2

§SOC=triple inhaled therapy (ICS + LABA + LAMA).

IIPost-bronchodilator FEV1/FVC ratio <0.7 and FEV1 of 20-80% predicted.

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

Implement a simple, once-monthly* dosing schedule

*Every 4 weeks.

NUCALA

Once-monthly
Once-monthly
NUCALA Autoinjector

NUCALA Autoinjector

100 mg/mL

NUCALA in-office lyophilized powder

NUCALA Lyophilized Powder

100 mg/mL

FLEXIBLE AT-HOME OR IN-OFFICE ADMINISTRATION

AT-HOME

Intended for use under HCP guidance. May be administered by the patient or caregiver. SC injection into the thigh or abdomen (or upper arm by caregiver). Provide proper training on injection technique and administration using the full Instructions for Use after determining at-home use is appropriate.

IN-OFFICE

NUCALA should be reconstituted and administered by a healthcare professional. SC injection into the upper arm, thigh, or abdomen. In line with clinical practice, monitoring of patients after administration of biologic agents is recommended.

Well-established safety profile based on the largest patient population studied for a COPD biologic

Safety data from 3 phase 3 trials including a 2-year study Safety data from 3 phase 3 trials including a 2-year study
Over 2000 patients - NUCALA: n=1043; Placebo: n=1046 Over 2000 patients - NUCALA: n=1043; Placebo: n=1046

ADVERSE REACTIONS ≥3% WITH NUCALA AND MORE COMMON THAN PLACEBO

(MATINEE: 52-104 WEEKS, METREX & TRIAL 3*: 52 WEEKS)

Adverse reactions across 3 phase 3 trials Adverse reactions across 3 phase 3 trials

Herpes zoster: Across the 3 COPD trials, 1% NUCALA and 0.7% placebo.

*Trial 3 was a 52-week dose-ranging COPD trial with NUCALA vs placebo in 449 adults with BEC ≥150 cells/μL at screening or ≥300 cells/μL in prior year.2

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

COPD patient Nicholas floating in a pool

Getting patients started on NUCALA

Help patients start and stay on NUCALA with resources for enrollment and access to treatment. Are you a biologic coordinator? These resources are for you.

VISIT NUCALA SUPPORT & ACCESS

Make NUCALA your first-choice biologic to treat 5 chronic inflammatory diseases

NUCALA is for SEA, CRSwNP, COPD, EGPA, or HES.

EXPLORE INDICATIONS