NUCALA HELPED EGPA PATIENTS ACHIEVE REMISSION

NUCALA patients achieved longer time in remission

Co-primary endpoint: Patients spent significantly more time in remission vs placebo over 52 weeks (OR: 5.9, 95% CI: 2.7, 13.0; P<0.001).1

PATIENTS WHO ACHIEVED SOME TIME IN REMISSION OVER 52 WEEKS

Bar graph representing the percentages of patients who achieved some time in remission over 52 weeks with NUCALA vs placebo2.8x as many patients achieved remission

Subanalysis. Results are descriptive.

square Placebo + SOC squareNUCALA 300 mg + SOC

2.8x as many patients achieved remissionBar graph representing the percentages of patients who achieved some time in remission over 52 weeks with NUCALA vs placebo

Subanalysis. Results are descriptive.

square Placebo + SOC
squareNUCALA 300 mg + SOC

Based on the above co-primary endpoint2

Remission benefit of NUCALA was consistent regardless of:

  • Duration of disease
  • Use of concomitant immunosuppressant therapy
  • Baseline BVAS
  • Baseline vascular damage index

Preplanned analyses. Results are descriptive.

Pivotal study design

Remission as defined in the pivotal trial1*

Prednisolone or prednisone dose ≤4 mg/day

BVAS3†=0

Infographic showing the BVAS score criteria

*The study definition was more stringent than the EULAR (European Alliance of Associations for Rheumatology) definition of remission (BVAS=0 and OCS dose ≤7.5 mg/day).1,4

†BVAS (Birmingham Vasculitis Activity Score) is a standardized, validated measure of vasculitis. Scores can range from 0 to 63, with higher scores meaning more active disease.3,5

More NUCALA patients achieved remission

Co-primary endpoint: Significantly more patients on NUCALA were in remission at both Week 36 and Week 48 vs placebo (OR: 16.7, 95% CI: 3.6, 77.6; P<0.001).1

Remission achieved at both Week 36 and Week 48

Pie charts showing the percentages of patients who spent time in remission with NUCALA vs placebo

Pivotal study designkeyboard_arrow_right

OCS with down arrow

Learn how NUCALA reduced daily OCS use

SEE OCS 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).

BVAS=Birmingham Vasculitis Activity Score; CI=confidence interval; ENT=ear nose throat; OCS=oral corticosteroid; OR=odds ratio; 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. Data on file, GSK.
  3. 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.
  4. Hellmich B, Flossmann O, Gross WL, et al. 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.
  5. 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.