PROVEN REDUCTION IN OCS USE

Trial 3:

Greater percentage reduction in daily OCS dose

(Weeks 20-24) while maintaining asthma control with NUCALA (n=69) vs placebo (n=66) (P=0.008), primary endpoint.1

Trial 3 study designkeyboard_arrow_right

OCS dose reduction and elimination

Daily OCS dose

REAL-WORLD STUDY (REALITI-A): DAILY MAINTENANCE OCS DOSE* IN OCS-DEPENDENT PATIENTS 

Real-world study (REALITI-A): daily maintenance OCS dose in OCS-dependent patients

in OCS dose at Weeks 45-64

Median maintenance OCS dose, Weeks 53-56 (n=218) vs baseline (n=297): 2.5 mg/day vs 10 mg/day.

Real-world study (REALITI-A): daily maintenance OCS dose in OCS-dependent patients

in OCS dose at Weeks 81-104

Median maintenance OCS dose, Weeks 101-104 (n=168) vs baseline (n=297): 0.0 mg/day vs 10 mg/day.

Secondary objective. All results are descriptive.

Real-world study limitations: 2-year, 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

*Baseline maintenance OCS dose defined as average daily dose in the 28 days prior to treatment index. Dose assessments based on data captured from medical records or patient recall, without documentation of asthma control.2

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

Real-world study designkeyboard_arrow_right

OCS elimination

Trial 3: 14% of NUCALA patients vs 8% of placebo patients completely eliminated daily OCS while maintaining asthma control at Weeks 20-24.1

Results are descriptive.

Trial 3 study designkeyboard_arrow_right

THE MAJORITY OF PATIENTS COMPLETELY ELIMINATED
OCS IN A REAL-WORLD STUDY2

57 percent

of patients
COMPLETELY ELIMINATED
maintenance OCS use* (95/168)
with NUCALA at 2 years (Weeks 101-104)

Secondary objective. Results are descriptive.

Real-world study limitations: 2-year, 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

*Baseline maintenance OCS dose (prednisone equivalent mg/day) defined as average daily dose in the 28 days prior to treatment index. Dose assessments based on data captured from medical records or patient recall without documentation of asthma control.2

Real-world study designkeyboard_arrow_right

OCS=oral corticosteroid.

Explore real-world data in patients with allergic characteristics

SEE COMORBIDITY DATA

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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. Bel EH, Wenzel SE, Thompson PJ, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189-1197.
  2. 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.
  3. Pilette C, Canonica GW, Chaudhuri R, et al. REALITI-A study: Real-world oral corticosteroid-sparing effect of mepolizumab in severe asthma. J Allergy Clin Immunol Pract. 2022;10(10):2646-2656.