PROTECT YOUR SEA PATIENTS FROM EXACERBATIONS WITH NUCALA

Exacerbation reduction data from a clinical trial and real-world study

Exacerbation reduction

Trial 2 (32 Weeks):

53 percent reduction53 percent reduction

in exacerbations/year with NUCALA + SOC (n=194) vs placebo + SOC (n=191) (0.83 vs 1.74, P<0.001), primary endpoint.1

 

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Real-world study (total population): 71% reduction with NUCALA (1-year post-exposure, N=820) vs pre-NUCALA (1-year pre-exposure, N=821), 1.24 vs 4.29, RR: 0.29 (95% CI: 0.26, 0.32), primary objective. Results are descriptive.2

REAL-WORLD STUDY:
EXACERBATION REDUCTION SUSTAINED OVER 2 YEARS3

Real world study: exacerbation reduction sustained over 2 years

  

Secondary objective. Results are descriptive.

 

Real-world study limitations: Single-arm, prospective, observational cohort study.

 

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

Secondary objective. Results are descriptive.

 

REAL-WORLD STUDY. REAL-WORLD PATIENTS. GET TO KNOW REALITI-A.

 

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Patients with zero exacerbations

Trial 2: Patients with zero exacerbations at Week 32: 67% with NUCALA (130/194) vs 45% with placebo (86/191). Results are descriptive.2

 

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REAL-WORLD STUDY:
ZERO EXACERBATIONS OVER 2 YEARS3

Real-world study: zero exacerbations over 2 years

  

Results are descriptive.

 

Real-world study limitations: Single-arm, prospective, observational cohort study.

 

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

Results are descriptive.

 

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Exacerbations across baseline EOS levels2

SUBGROUP ANALYSIS: REAL-WORLD STUDY (1-YEAR ANALYSIS) EXACERBATION RATES BY BASELINE BLOOD EOS LEVEL (CELLS/μL)2*

Subgroup analysis: real-world study (1-year analysis) exacerbation rates by baseline blood EOS level (cells/μL)Subgroup analysis: real-world study (1-year analysis) exacerbation rates by baseline blood EOS level (cells/μL)

 

square Pre-NUCALA (1-year pre-exposure)
square NUCALA (1-year post-exposure)

 

Real-world study subgroup analysis by baseline blood EOS level <150 cells/µL: 65% reduction with NUCALA (n=98) vs pre-NUCALA (n=98), 1.46, 4.16, RR: 0.35 (95% CI: 0.27, 0.46).2

 

Post hoc analysis. All results are descriptive.

 

Real-world study limitations: Single-arm, prospective, observational cohort study.

 

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

 

*614 patients had analyzable data for baseline blood EOS levels within 90 days of starting NUCALA. Results from final data delivered after 2 years.2

 

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Lung function

Trials 2 and 3: Numerical improvements in lung function were observed. Difference in mean change from baseline in FEV1 at end of treatment (95% CI) with NUCALA vs placebo: Trial 2, 98 mL (11, 184) at Week 32; Trial 3, 114 mL (-42, 271) at Week 24. Improvements were not consistent.

 

Results are descriptive.

 

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REAL-WORLD STUDY: LUNG FUNCTION3

142 mL

INCREASE

from baseline pre-bronchodilator FEV1

Mean change from baseline (95% CI) at 2 years: 142 mL (53, 231), n=165.* LS mean (95% CI): 2108 mL (2014, 2202) with NUCALA (2-years post-exposure, n=165)* vs 1966 mL (1890, 2042) at baseline (pre-NUCALA, n=398).

Other objective. Results are descriptive.

Real-world study limitations: Single-arm, prospective, observational cohort study.

 

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. Limitations important when interpreting results: no comparator arm; differences in patient populations and data collection vs randomized controlled trials.2

 

*Number of participants with clinic FEV1 value within 90 days of time point.

 

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CI=confidence interval; EOS=eosinophils; FEV1=forced expiratory volume in 1 second; OCS=oral corticosteroid; RR=rate ratio.

Learn about NUCALA and daily OCS use

SEE OCS DATA

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

NUCALA is indicated for the: 

  • 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.
  • 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-MPLWCNT240085 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. Ortega HG, Liu MC, Pavord ID, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-1207.

  2. Data on file, GSK.

  3. Caruso C, Canonica GW, Patel M, et al. Prospective REALITI-A study: 2-year real-world benefits of mepolizumab in severe asthma. Chest Pulm. 2024;100107.