EOSINOPHILIC INFLAMMATION CAN DRIVE RECURRENT NASAL POLYPS1,2

Recurrent nasal polyps and eosinophilic inflammation

Up to 90 percent of nasal polyps have predominantly eosinophilic inflammation

*Based on studies that examined the presence of eosinophil leukocyte infiltration in nasal polyp biopsy tissue of patients in the US and Europe.1-4

After surgery, nasal polyp recurrence was three times greater in patients with elevated eosinophils

† Based on a retrospective, single-center study to investigate the relationship between eosinophil density in nasal polyp tissue and recurrence in adults who underwent endoscopic sinus surgery for massive nasal polyposis (filled at least half of each nostril). Patients were categorized as higher density (>4 eosinophils/1000 µm2) or lower density (≤3 eosinophils/1000 µm2) by examining digital images taken at x400 magnification.2

NP=nasal polyp.

Elevated eosinophils in nasal polyps are associated with1-4:

  • Presence of INFLAMMATION
  • Greater likelihood of NASAL POLYP RECURRENCE after surgical removal

How NUCALA targets eosinophils

Diagram showing how NUCALA (mepolizumab) targets eosinophilsDiagram showing how NUCALA (mepolizumab) targets eosinophils

The MOA of NUCALA in CRSwNP has not been definitively established.

    Reduced blood eosinophil levels and maintained within normal‡ levels5,6

    NUCALA reduced blood eosinophil levels and maintained within normal levelsNUCALA reduced blood eosinophil levels and maintained within normal levels
    80 percent reduction in blood eosinophil levels with NUCALA at Week 4, maintained at 84 percent at Week 52

    in blood eosinophil levels with NUCALA at Week 4, maintained at 84% at Week 525,6

    NUCALA ratio to baseline: Week 4, 0.20; Week 52, 0.16.

    Mean blood eosinophil levels (NUCALA, placebo)

    • Baseline: 390 cells/µL, 400 cells/µL
    • At Week 52: 60 cells/µL, 360 cells/µL

    All results are descriptive. The clinical significance of these pharmacodynamic data is unknown.

    ‡ Mean normal blood eosinophil levels in a general population of subjects without confounding factors have been reported as 100 cells/µL (range: 34-257) and 107 cells/µL (5th, 95th percentile: 30, 395); levels vary based on age, sex, environmental exposures, and comorbid conditions.7,8

    SYNAPSE study design

    What role do blood eosinophils play?

    Eosinophils play a role in maintaining health, including regulation of the immune system, regenerating and repairing tissue, and protecting the host (eg, defending the body against parasitic infection).9 In CRSwNP, however, elevated eosinophils are a key driver of CRSwNP pathophysiology, including inflammation.2,3

    Nasal polyps patient Marco eating takeout food with three friends

    WHICH OF YOUR CRSwNP PATIENTS COULD BENEFIT FROM NUCALA?

    GO TO PATIENT PROFILES
    Nasal polyps patient Janet drinking coffee while talking to man on couch

    EXPLORE NUCALA DATA IN CRSwNP PATIENTS

    VIEW NUCALA EFFICACY

    INDICATIONS & IMPORTANT SAFETY INFO

    INDICATIONS

    IMPORTANT SAFETY INFORMATION

    INDICATIONS

    NUCALA is indicated for the: 

    • 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 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 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-MPLWCNT240086 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. Lou H, Meng Y, Piao Y, et al. Cellular phenotyping of chronic rhinosinusitis with nasal polyps. Rhinology. 2016;54(2):150-159.
    2. Tosun F, Arslan HH, Karslioglu Y, Deveci MS, Durmaz A. Relationship between postoperative recurrence rate and eosinophil density of nasal polyps. Ann Otol Rhinol Laryngol. 2010;119(7):455-459.
    3. Fujieda S, Imoto Y, Kato Y, et al. Eosinophilic chronic rhinosinusitis. Allergol Int. 2019;68(4):403-412.
    4. Stoop AE, van der Heijden HA, Biewenga J, van der Baan S. Eosinophils in nasal polyps and nasal mucosa: an immunohistochemical study. J Allergy Clin Immunol. 1993;91(2):616-622.
    5. Han JK, Bachert C, Fokkens W, et al. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2021;9(10):1141-1153.
    6. Data on file, GSK.
    7. Felarca AB, Lowell FC. The total eosinophil count in a nonatopic population. J Allergy. 1967;40(1):16-20.
    8. Hartl S, Breyer MK, Burghuber OC, et al. Blood eosinophil count in the general population: typical values and potential confounders. Eur Respir J. 2020;55(5):1901874.
    9. Weller PF, Spencer LA. Functions of tissue-resident eosinophils. Nat Rev Immunol. 2017;17(12):746-760.