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

    METREX: 52-week pivotal study

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      EXPLORE NUCALA DATA IN COPD PATIENTS WITH AN EOSINOPHILIC PHENOTYPE

      VIEW NUCALA EFFICACY

      INDICATIONS & IMPORTANT SAFETY INFO

      INDICATIONS

      IMPORTANT SAFETY INFORMATION

      INDICATIONS

      NUCALA is indicated for the: 

      • add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm.
      • add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma and with an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm or status asthmaticus.
      • add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients aged 18 years and older with inadequate response to nasal corticosteroids.
      • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
      • treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for greater than or equal to 6 months without an identifiable non-hematologic secondary cause. 

      IMPORTANT SAFETY INFORMATION

      CONTRAINDICATIONS

      Known hypersensitivity to mepolizumab or excipients.

       

      WARNINGS AND PRECAUTIONS

      Hypersensitivity Reactions

      Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, days). Discontinue if a hypersensitivity reaction occurs.

       

      Acute Symptoms of Asthma or COPD or Acute Deteriorating Disease

      NUCALA should not be used to treat acute symptoms or acute exacerbations of asthma or COPD, or acute bronchospasm.

       

      Opportunistic Infections: Herpes Zoster

      Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.

       

      Reduction of Corticosteroid Dosage

      Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

       

      Parasitic (Helminth) Infection

      Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

       

      ADVERSE REACTIONS

      Most common adverse reactions (≥5%):

      • Severe asthma trials: headache, injection site reaction, back pain, fatigue
      • CRSwNP trial: oropharyngeal pain, arthralgia
      • COPD trials: back pain, diarrhea, cough
      • EGPA and HES trials (300 mg of NUCALA): most common adverse reactions were similar to severe asthma

      Systemic reactions, including hypersensitivity, occurred in clinical trials in patients receiving NUCALA. Manifestations included rash, pruritus, headache, myalgia, flushing, urticaria, erythema, fatigue, hypertension, warm sensation in trunk and neck, cold extremities, dyspnea, stridor, angioedema, and multifocal skin reaction. A majority of systemic reactions were experienced the day of dosing.

       

      USE IN SPECIFIC POPULATIONS

      The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

       

      Please see full Prescribing Information and Patient Information for NUCALA.

      PMUS-MPLWCNT250056 June 2025

      To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or 1-888-825-5249 or
      FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

      References

      1. Sciurba FC, Criner GJ, Christenson SA, et al. Mepolizumab to prevent exacerbations in COPD with an eosinophilic phenotype. N Engl J Med. 2025;392:1710-1720.
      2. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2025 report. https://goldcopd.org/2025-gold-report. Accessed March 6, 2025.
      3. Pavord ID, Chanez P, Criner GJ, et al. Mepolizumab for eosinophilic chronic obstructive pulmonary disorder. N Engl J Med. 2017;377(17):1613-1629.
      4. Data on file, GSK.
      5. Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988;93(3):580-586.
      6. Meguro M, Barley EA, Spencer S, Jones PW. Development and validation of an improved, COPD-specific version of the St. George Respiratory Questionnaire. Chest. 2007;132(2):456-463.