LONG-TERM DATA IN 4.5-YEAR OPEN-LABEL STUDY

In patients with severe eosinophilic asthma (SEA), NUCALA was evaluated in a 4.5-year open-label safety and efficacy study. Primary endpoint was long-term safety.1,2

 

Trial 2 (32 Weeks, N=576): 53% reduction in exacerbations per year with NUCALA + SOC vs placebo + SOC (0.83 vs 1.74, P<0.001), primary endpoint.3

 

Trial 2 study designkeyboard_arrow_right

 

4.5-year open-label study (N=347): 61% reduction in mean rate of exacerbations/year* at 4.5 years vs period between Trial 1† and open-label study. Secondary endpoint: Annualized exacerbation rate: 0.68 (95% CI: 0.60, 0.78).1 All results are descriptive.

 

4.5-year open-label study design & primary endpoint (safety)keyboard_arrow_right

 

*Based on exacerbations reported from the time a patient enrolled until study withdrawal. Median duration 3.8 years.2

†Trial 1 was a 52-week dose-ranging exacerbation trial.

CI=confidence interval; SOC=standard of care.

Exacerbation reduction

4.5-YEAR OPEN-LABEL STUDY:
NUMBER OF EXACERBATIONS* IN ALL PATIENTS (N=347)2

4.5-year open-label study: number of exacerbations in all patients (N=347)

Results are descriptive.

 

*Based on exacerbations reported from the time a patient enrolled until study withdrawal. Median duration 3.8 years.2

Hear from a peer

NUCALA efficacy & safety in SEA | 15:58

An expert in pulmonology and critical care medicine describes how NUCALA can help patients with severe eosinophilic asthma (SEA), including an overview of safety and efficacy data.

NUCALA safety profile in controlled asthma trials and a long-term access study

SEE THE DATA

BLOOD EOSINOPHIL UNIT CONVERSION CALCULATOR

In asthma, an elevated EOS count is a sign that your patient may have eosinophilic asthma. Obtain an absolute eosinophil count in cells/µL from lab results to help decide if NUCALA is right for your patient.

GET EOSINOPHIL COUNTS

GATEWAY TO NUCALA ENROLLMENT FORM

For biologic coordinators and other HCPs who help patients manage their NUCALA injection therapy: get resources right now to help them start and stay on NUCALA.

GO TO ACCESS & SUPPORT

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. Khatri S, Moore W, Gibson PG, et al. Assessment of the long-term safety of mepolizumab and durability of clinical response in patients with severe eosinophilic asthma. J Allergy Clin Immunol. 2019;143(5):1742-1751.

  2. Data on file, GSK.

  3. 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.