IMPROVEMENT IN PATIENTS WITH COMORBIDITIES

Co-primary endpoint: LS mean* change from baseline in nasal obstruction score† during Weeks 49-52 (total population). NUCALA + SOC, –4.40 vs placebo + SOC, –2.54; P<0.001.1,2

Reduction in nasal obstruction in patients with comorbidities



Subgroup analysis graph of LS mean change from baseline in nasal obstruction score at Weeks 49-52 in patients with comorbid asthma and comorbid AERD showing a reduction in nasal obstruction score

*LS means from an analysis using mixed model repeated measures.

†Symptom severity measured on patient-reported VAS from 0 (none) to 10 (as bad as you can imagine).

‡Also known as NERD.

 

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Improvement in asthma control in CRSwNP patients with comorbid asthma2

Subgroup analysis graph of LS mean change from baseline in ACQ-5 over 52 weeks for NUCALA and placebo showing the improvement in asthma control in patients with comorbid asthmaSubgroup analysis graph of LS mean change from baseline in ACQ-5 over 52 weeks for NUCALA and placebo showing the improvement in asthma control in patients with comorbid asthma
57 percent of patients had a clinically important difference in ACQ-5 (responder criteria) on NUCALA vs 35 percent on placebo at Week 52 infographic57 percent of patients had a clinically important difference in ACQ-5 (responder criteria) on NUCALA vs 35 percent on placebo at Week 52 infographic

§Scores on the ACQ range from 0 to 6 with higher scores indicating worse control.

llLS means from analysis using mixed model repeated measures.

Defined as improvement in ACQ-5 total score of ≥0.5 points from baseline for MCID.

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META-ANALYSIS: SEVERE EOSINOPHILIC ASTHMA

See asthma exacerbation data by nasal polyps

EXPLORE THE DATA

NUCALA is for the add-on treatment of patients 6+ with severe eosinophilic asthma. Not for acute bronchospasm or status asthmaticus.

ACQ-5=Asthma Control Questionnaire (5-item); AERD=aspirin-exacerbated respiratory disease; CI=confidence interval; LS=least squares; MCID=minimum clinically important difference; NERD=nonsteroidal anti-inflammatory drug (NSAID)-exacerbated respiratory disease; OR=odds ratio; SOC=standard of care; VAS=visual analog scale.

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INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

NUCALA is indicated for the: 

  • 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.
  • 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 adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. NUCALA is not indicated for the relief of acute bronchospasm.
  • 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-MPLWCNT240086 May 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. Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(10):1141-1153.

  2. Data on file, GSK.