DAILY OCS DOSE REDUCTION

NUCALA reduced daily OCS dose1

Secondary endpoint: Significantly more patients receiving NUCALA 300 mg + SOC achieved a lower daily OCS dose during the last 4 weeks of treatment vs placebo + SOC (OR: 0.20; 95% CI: 0.09, 0.41; P<0.001)1*

59 percent of NUCALA patients reduced daily OCS vs 34 percent placebo

(NUCALA, n=40/68 vs placebo, n=23/68)

18 percent of NUCALA patients completely eliminated daily OCS vs 3 percent placebo

(NUCALA, n=12/68 vs placebo, n=2/68)

All results are descriptive from secondary endpoint.

*NUCALA and placebo were administered in addition to SOC, defined as OCS +/- immunosuppressants. After Week 4, OCS (prednisolone or prednisone) dose could be tapered, per physician judgment or a suggested protocol.1

Pivotal study designkeyboard_arrow_right

OCS reduction in a 7.4-year open-label study3

Long-term access study objectives: Objectives of this 7.4-year, multicenter study were to supply NUCALA to eligible patients in the MIRRA trial and to collect additional safety data.

Mean exposure to NUCALA: 38.5 months (3.2 years) with a range of 1 to 89 months (7.4 years).

68 percent of NUCALA patients reduced daily OCS at study exit vs 25 percent at baseline

(n=68/100 vs n=25/100)

Median daily OCS dose (range): 10.0 mg (0-70 mg) at baseline† (n=98), 5.0 mg (0-40 mg) at study exit* (n=72)

27 percent of NUCALA patients completely eliminated OCS at study exit

(n=27/100)

25% of patients had no change or an increase in daily OCS dose at study exit (n=25/100)

Post hoc analyses. All results are descriptive.

*OCS dose at baseline in 2 patients was initially classified as 0 mg/day due to gap in reporting concomitant medications, but were confirmed as ≥5 mg/day.
†In the long-term access study, OCS dose at study exit is the last reported OCS dose (prednisolone equivalent) before patients reached study end/completed (coinciding with local commercial license of NUCALA for EGPA) or discontinued treatment early.

7.4-year open-label study designkeyboard_arrow_right

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Learn how NUCALA reduced relapse rates

SEE RELAPSE DATA
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 | 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).

CI=confidence interval; OCS=oral corticosteroid; OR=odds ratio; SC=subcutaneous; SOC=standard of care.

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. 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.

  2. Supplementary appendix to 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)(suppl):1-23.

  3. Data on file, GSK.