CLINICAL BENEFIT EXPERIENCED WITH NUCALA

Clinical Benefit was defined as1:

Infographic of the clinical benefit criteria

The study definition of remission was more stringent than the EULAR (European Alliance of Associations for Rheumatology) definition of remission (BVAS=0 and OCS dose ≤7.5 mg/day).2,3
*Remission was defined as Birmingham Vasculitis Activity Score (BVAS)=0 (no active vasculitis) plus OCS dose ≤4 mg/day.1
†Relapse was defined as a worsening related to vasculitis, asthma, or sinonasal symptoms requiring an increase in dose of corticosteroids, increase in dose or addition of immunosuppressive therapy, or hospitalization.2

Post hoc analyses: A higher proportion of patients experienced a Clinical Benefit1

PATIENTS WITH CLINICAL BENEFIT‡

Bar graph showing percentages of patients who experienced at least one clinical benefit with NUCALA vs placebo

Post hoc analysis. Results are descriptive.

‡Patients who experienced ≥1 component of clinical benefit.

PATIENTS WHO EXPERIENCED ALL THREE COMPONENTS OF CLINICAL BENEFIT1

Pie chart showing percentages of patients who experienced all 3 components of clinical benefit with NUCALA vs placeboPie chart showing percentages of patients who experienced all 3 components of clinical benefit with NUCALA vs placebo

Post hoc analysis. All results are descriptive.

Post hoc analysis: A higher proportion of patients experienced each component of Clinical Benefit1

PATIENTS WHO ACHIEVED EACH COMPONENT OF CLINICAL BENEFIT

Bar graph showing percentages of patients who experienced each component of clinical benefit with NUCALA vs placebo

Post hoc analysis. Results are descriptive.

Placebo + SOC (n=68)

NUCALA 300 mg + SOC (n=68)

Pivotal study design keyboard_arrow_right

BVAS=Birmingham Vasculitis Activity Score; OCS=oral corticosteroid; SOC=standard of care.

NUCALA the only EGPA biologic with safety data up to 7.4 years

NUCALA is the ONLY EGPA biologic with safety data up to 7.4 years

REVIEW LONG-TERM SAFETY

Hear from a peer about NUCALA

EGPA vs HES I 9:06

An expert in allergy and immunology describes how to differentiate two diseases related to peripheral blood eosinophilia: eosinophilic granulomatosis with polyangiitis (EGPA) and hypereosinophilic syndrome (HES).

INDICATIONS & IMPORTANT SAFETY INFO

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

NUCALA is indicated for the: 

  • treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • 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 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-MPLWCNT240087 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. Steinfeld J, Bradford ES, Brown J, et al. Evaluation of clinical benefit from treatment with mepolizumab for patients with eosinophilic granulomatosis with polyangiitis. J Allergy Clin Immunol. 2019;143(6):2170-2177.

  2. Wechsler ME, Akuthota P, Jayne D, et al; for the EGPA Mepolizumab Study Team. Mepolizumab or placebo for eosinophilic granulomatosis with polyangiitis. N Engl J Med.  2017;376(20):1921-1932.

  3. Hellmich B, Flossmann O, Gross WL, et al; on behalf of the European Vasculitis Study Group. EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis. Ann Rheum Dis. 2007;66(5):605-617.