COPD & EOS PHENOTYPE

COPD is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to abnormalities of the airways and/or alveoli that cause persistent, progressive airflow obstruction.1

COPD prevalence

In the United States, COPD affects ~14.2 million people (reported in 2021).2

Elevated eosinophils can play a key role in COPD

The GOLD Report acknowledges that higher BEC in patients with COPD is associated with increased lung eosinophil counts and the presence of higher levels of markers of type 2 inflammation in the airways.1 Type 2 inflammation characterized by blood eosinophils in patients with COPD is associated with increased risk, frequency, and severity of exacerbations.1,3,4

Patients with an EOS phenotype are at greater risk of COPD exacerbations and related hospital visits*

Up to 76% (25-76%) greater risk of COPD exacerbations
Up to 68% (18-68%) greater risk of hospital visits due to COPD exacerbations

*Hospitalizations or ED visits.

†Across BEC thresholds (cells/µL): ≥300 vs <300, RR: 1.25; ≥400 vs <400, RR: 1.48; ≥500 vs <500, RR: 1.76.4 Results are descriptive.

‡Across BEC thresholds (cells/µL): ≥300 vs <300, RR: 1.18; ≥400 vs <400, RR: 1.44; ≥500 vs <500, RR: 1.68.4 Results are descriptive.

Retrospective cohort study in a managed care setting (Kaiser Permanente Southern California Research Data Warehouse, 2009-2012) that examined the relationship between baseline BEC and COPD exacerbations in the 1-year follow-up of 7245 patients aged ≥40 years diagnosed with COPD. COPD exacerbations were defined as hospitalizations or ED visits with a primary diagnosis of COPD, or outpatient visits with systemic corticosteroid dispensing within 14 days of an exacerbation.4

Are your patients at risk for COPD exacerbations and related hospital visits?

EXPLORE AT-RISK PATIENTS

BEC=blood eosinophil count; ED=emergency department; EOS=eosinophilic; GOLD=Global Initiative for Chronic Obstructive Lung Disease; RR=rate ratio.

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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. 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 July 30, 2025.
  2. Liu Y, Carlson SA, Watson KB, Xu F, Greenlund KJ. Trends in the prevalence of chronic obstructive pulmonary disease among adults aged ≥18 years - United States, 2011-2021. MMWR Morb Mortal Wkly Rep. 2023;72(46):1250-1256.
  3. Brightling C, Greening N. Airway inflammation in COPD: progress to precision medicine. Eur Respir J. 2019;54(2):1900651.
  4. Zeiger RS, Tran TN, Butler RK, et al. Relationship of blood eosinophil count to exacerbations in chronic obstructive pulmonary disease. J Allergy Clin Immunol Pract. 2018;6:944-954.