EXACERBATION DATA IN SEA PATIENTS WITH COMORBIDITIES

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

61% reduction in exacerbations/year requiring hospitalization/ED visit (0.08 vs 0.20, P=0.02), secondary endpoint.1

Trial 2 study designkeyboard_arrow_right

Real-world study (REALITI-A) (total population, N=822): 71% reduction in exacerbations/year with NUCALA (1-year post-exposure) vs pre-NUCALA (1-year pre-exposure), 1.24 vs 4.29, rate ratio: 0.29 (99% CI: 0.26, 0.32), primary objective.2 Results are descriptive.

Real-world study designkeyboard_arrow_right

Real-world exacerbation reduction data in SEA patients with allergic characteristics

A real-world study evaluated reduction in asthma exacerbations in a large, diverse population with baseline characteristics including2,3:

Total IgE levels

Allergic status

FeNO levels

REALITI-A study designkeyboard_arrow_right

SEA with allergic characteristics: real-world exacerbation data

Exacerbations across total IgE levels

SUBGROUP ANALYSIS: REAL-WORLD STUDY (1-YEAR INTERIM ANALYSIS) EXACERBATION RATES BY BASELINE TOTAL IgE2*

Post hoc analysis. Results are descriptive.

Pre-NUCALA (1-year pre-exposure)

NUCALA (1-year post-exposure)

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

 

*674 patients had analyzable data for baseline total IgE levels within 90 days of starting NUCALA.2

 

Exacerbations by baseline allergic status

SUBGROUP ANALYSIS: REAL-WORLD STUDY (1-YEAR INTERIM ANALYSIS) EXACERBATION RATES BY ALLERGIC STATUS2*†

Subgroup analysis: real-world study (1-year interim analysis) exacerbation rates by allergic status

Post hoc analysis. Results are descriptive.

Pre-NUCALA (1-year pre-exposure)

NUCALA (1-year post-exposure)

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

 

*472 patients had analyzable data for assessment of baseline allergic status.2

†Allergic (atopic) status was determined by a positive skin prick test or positive RAST score ≥1 (≥0.35 kU/L) for ≥1 specific IgE allergen.2

 

Exacerbations by baseline FeNO level

SUBGROUP ANALYSIS: REAL-WORLD STUDY (1-YEAR INTERIM ANALYSIS) EXACERBATION RATES BY BASELINE FeNO LEVEL2*

Subgroup analysis: real-world study (1-year interim analysis) exacerbation rates by baseline FeNO level

Post hoc analysis. Results are descriptive.

Pre-NUCALA (1-year pre-exposure)

NUCALA (1-year post-exposure)

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

 

*360 patients had analyzable data for baseline FeNO levels within 90 days of starting NUCALA.2

 

Exacerbations requiring hospitalization

Trial 2: 69% reduction in exacerbations requiring hospitalization with NUCALA vs placebo, 0.03 vs 0.10, rate ratio: 0.31 (95% CI: 0.11, 0.91).1 Results are descriptive.

Real-world study (REALITI-A): 69% reduction in exacerbations requiring hospitalization with NUCALA (1-year post-exposure, N=820) vs pre-NUCALA (1-year pre-exposure, N=821), 0.14 vs 0.45, rate ratio: 0.31 (95% CI: 0.24, 0.39), secondary objective. 91% had zero exacerbations requiring hospitalization with NUCALA vs 76% pre-NUCALA.2 All results are descriptive.

Exacerbations requiring hospitalization in subgroup with comorbid nasal polyps*

95 percent

of patients had ZERO EXACERBATIONS requiring hospitalization with NUCALA vs 82% pre-NUCALA2

89% of patients had zero exacerbations with NUCALA vs 73% pre-NUCALA.2

Post-hoc analysis. Results are descriptive.

Real-world study limitations: single-arm, prospective, observational cohort study. Prespecified interim analysis. May not reflect final results. Interpret results using limitations in study design.2

*Nasal polyps reported as past medical condition at baseline.

Real-world study designkeyboard_arrow_right

CI=confidence interval; FeNO=fractional exhaled nitric oxide; IgE=immunoglobulin E; RAST=radioallergosorbent test; SOC=standard of care.

Explore the well-established safety profile

VIEW NUCALA SAFETY

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.