NUCALA IMPROVED QUALITY OF LIFE, BASED ON SNOT-22

SIGNIFICANT IMPROVEMENT IN QUALITY OF LIFE, BASED ON SNOT-22*

30

point improvement with NUCALA vs 14 point improvement with placebo in SNOT-22 total score median change from baseline at Week 521,2

Secondary endpoint.
NUCALA + SOC (n=206; baseline, 64) vs placebo + SOC (n=201; baseline, 64); P=0.0032.1,2

PATIENTS WHO MET RESPONDER CRITERIA†

73%

of patients had a clinically important difference in SNOT-22 on NUCALA vs 54% on placebo at Week 521,2

Other endpoint. Results are descriptive.
NUCALA + SOC (n=205) vs placebo + SOC (n=198), OR: 2.44 (95% CI: 1.60, 3.73).

*SNOT-22=Health-related quality-of-life tool that assesses symptoms and impact associated with CRS.3

†Defined as a reduction in SNOT-22 total score of ≥8.9 points in the absence of surgery for minimum clinically important difference (MCID).1,3

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SNOT-22: Symptom and impact improvement in all 6 domains2‡

SNOT-22: Symptom and impact improvement in all 6 domains

‡SNOT-22 not designed to measure changes in individual questions.

SYNAPSE study design

Questions2,3

Nasal

  • Need to blow nose
  • Nasal blockage
  • Sneezing
  • Runny nose
  • Thick nasal discharge
  • Decrease sense of smell/taste

Non-nasal

  • Cough
  • Post-nasal discharge

Ear/facial

  • Ear fullness
  • Dizziness
  • Ear pain
  • Facial pain

Sleep

  • Difficulty falling asleep
  • Wake up at night
  • Lack of good night’s sleep

Fatigue

  • Wake up tired
  • Fatigue
  • Reduced productivity
  • Reduced concentration

Emotional consequences

  • Frustrated/restless/irritable
  • Sad
  • Embarrassed

SNOT-22: Symptom and impact improvement in all 6 domains2‡

    All results are descriptive.

    ‡SNOT-22 not designed to measure changes in individual questions.

    SYNAPSE study design

    CI=confidence interval; OR=odds ratio; SNOT-22=sino-nasal outcome test (22-item); SOC=standard of care.

    Learn about the data for NUCALA in patients with comorbidities

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    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. 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.

    2. Data on file, GSK.

    3. Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009;34(5):447-454. Supplementary Appendix.