NUCALA REDUCED RELAPSE RATES1

Secondary endpoint: Patients on NUCALA had significantly longer time to first relapse1*

TIME TO FIRST RELAPSE

Graph of time to first relapse with NUCALA vs placeboGraph of time to first relapse with NUCALA vs placebo

NUCALA vs placebo, HR: 0.32 (95% CI: 0.21, 0.50); P<0.001

Placebo + SOC (n=68)

NUCALA 300 mg + SOC  (n=68)

50 percent reduction in annualized relapse rate vs placebo 50 percent reduction in annualized relapse rate vs placebo

Other endpoint. Results are descriptive.
NUCALA vs placebo, RR: 0.50;
annualized relapse rate 1.14 vs 2.27 (95% CI: 0.36, 0.70).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.1

†NUCALA and placebo were administered in addition to standard of care (SOC).1

bar image bars at Weeks 16, 32, and 52 indicate 95% confidence intervals.

 

Reduction in relapse rates by type1

Subgroup analysis: The incidence and number of relapses by type were lower with NUCALA + SOC vs placebo + SOC2*

TOTAL NUMBER OF RELAPSES BY TYPE

Bar graph of relapse rates in patients treated with NUCALA vs placebo

Subgroups by relapse type were not large enough to determine statistical significance; therefore, results are descriptive only.

Placebo + SOC  (n=68)

NUCALA 300 mg + SOC  (n=68)

*SOC was defined as OCS +/– immunosuppressants. After Week 4, OCS (prednisolone or prednisone) dose could be tapered per physician judgment or a suggested protocol.1

 

RELAPSE TYPES2

Relapse types

*BVAS is a standardized, validated measure of vasculitis. Scores can range from 0 to 63, with higher scores meaning more active disease.3,4

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Learn how NUCALA helped patients experience clinical benefit

SEE CLINICAL BENEFIT 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).

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. Mukhtyar C, Lee R, Brown D, et al. Modification and validation of the Birmingham Vasculitis Activity Score (version 3). Ann Rheum Dis. 2009;68(12):1827-1832.
  4. Supplementary appendix to Mukhtyar C, Lee R, Brown D, et al. Modification and validation of the Birmingham Vasculitis Activity Score (version 3). Ann Rheum Dis. 2009;68(12)(suppl):1-3.