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Pick section Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Improvement in patients with comorbidity

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Reduction in asthma exacerbations

Reduction in asthma exacerbations

Nucala reduces exacerbations in patients with co-morbid nasal polyps and asthma.1,2

In nasal polyps patients with comorbid asthma

SYNAPSE1,5

67 percent

Post hoc analysis: rate ratio: 0.33, 95% CI:0.12, 0.951*

In patients with severe eosinophilic asthma with comorbid nasal polyps:

MENSA3/MUSCA4 - post hoc meta-analysis

80 percent

Rate ratio: 0.20, 95% CI: 0.11, 0.35. N=1662
49% reduction in clinically significant asthma exacerbations in patients without nasal polyps (rate ratio: 0.51, 95% CI: 0.41, 0.64). N=7702

View MENSA Study

View MUSCA Study

  • View MENSA Study

    MENSA: Study design

    DESCRIPTION3
    A 32-week, multicentre, randomised, double-blind, double-dummy, placebo-controlled Phase III study comparing treatment with Nucala 100mg SC or mepolizumab 75mg IV to placebo, added to standard of care in patients with severe eosinophilic asthma.

    ENDPOINTS3
    Primary endpoint: annualised frequency of clinically significant exacerbations.*

    Secondary endpoints: increase from baseline in pre-bronchodilator FEV1, improvement in SGRQ total scores, improvement in ACQ-5 scores, responses as rated by patients and clinicians, and blood eosinophil count.

    STUDY POPULATION, N=5763
    Patients 12 years or older with severe asthma with an eosinophilic phenotype (≥150 cells/µL at baseline or ≥300 cells/µL within the last 12 months).

    NA

    The presence of nasal polyps was determined from patients’ medical records and/or external nasal examination at baseline.2

    Note: Mepolizumab 75mg IV is not an approved dose/route of administration.
    *Defined as worsening of asthma that required systemic glucocorticosteroids for 3 or more days, or hospitalisation/emergency department visit.3
    ACQ-5, asthma control questionnaire; FEV1, forced expiratory volume in 1 second; IV, intravenous; SC, subcautaneous; SGRQ, St. George's Respiratory Questionnaire.

  • View MUSCA Study

    MUSCA: Study design

    DESCRIPTION4
    A 24-week, multicentre, randomised, double-blind, placebo-controlled, Phase III study assessing the effect of Nucala compared with placebo added to standard of care in patients with severe eosinophilic asthma.

    ENDPOINTS4
    Primary endpoint: mean change from baseline in SGRQ scores at Week 24.

    Secondary endpoints: (all measured at Week 24): mean change from baseline in pre-bronchodilator FEV1, proportion of SGRQ total score responders, mean change from baseline in ACQ-5 score.

    STUDY POPULATION, N=5514
    Patients 12 years or older with sever asthma with an eosinophilic phenotype (≥150 cells/µL at baseline or ≥300 cells/µL within the last 12 months).

    NA

    The presence of nasal polyps was determined from patients’ medical records and/or external nasal examination at baseline.2

    ACQ-5, asthma control questionnaire; FEV1, forced expiratory volume in 1 second; SC subcautaneous; SGRQ, St. George's Respiratory Questionnaire.

SELECTED SAFETY INFORMATION

Warnings/Precautions: Should not be used to treat acute asthma exacerbations. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after starting treatment. Abrupt discontinuation of corticosteroids after initiation of mepolizumab treatment is not recommended.
Allergic reactions: Acute and delayed systemic reactions, including hypersensitivity reactions, have occurred following administration of mepolizumab. Patients should be instructed to seek medical attention immediately if allergic reactions occur. In the event of a hypersensitivity reaction, appropriate treatment as clinically indicated should be initiated.
Parasitic infections: Pre-existing helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Organ-threatening or life-threatening manifestations of EGPA and HES: Has not been studied
Adverse reactions: In clinical studies in patients with severe refractory eosinophilic asthma and EGPA, headache, injection site reactions and back pain were the most commonly reported adverse reactions during treatment. In patients with CRSwNP: Headache and back pain. In patients with HES: Headache, urinary tract infection, injection site reactions and pyrexia.

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SAFETY

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Dosing and ADMINISTRATION

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EOSINOPHILS & MOA

SYNAPSE is a 52-week, randomised, double-blind, parallel group Phase III study assessing the clinical efficacy and safety of Nucala 100mg SC as an add-on to maintenance treatment in adults with severe bilateral nasal polyps, compared to placebo.5 Other objective: change from baseline in ACQ-5 score at Week 52. Asthma control was improved by 50% from baseline with Nucala (n=138) vs. 19% in placebo (n=144) by Week 52 of treatment in patients with asthma and comorbid nasal polyps Mean ACQ-5 score decrease of -1.18 from mean baseline score of 2.38 in treatment group vs. -0.40 from 2.15 in placebo.1 MCID ≥0.5;6 scores out of 6, >1.5 indicates poor symptom control.7

*Post hoc analysis: exacerbations per year for participants with asthma, Nucala: 0.05 (95% CI: 0.02, 0.12), placebo: 0.15 (95% CI: 0.08, 0.26).1

†Based on meta-analysis of MENSA and MUSCA, of 936 patients to determine change in HRQoL in Nucala-treated patients with SEA either with or without nasal polyps.2 MENSA and MUSCA were Phase III placebo-controlled, randomised, double-blind, parallel group, multicentre studies.3,4 Primary endpoint in MENSA, annualised frequency of clinically significant exacerbations (defined as worsening of asthma that required systemic glucocorticoids for 3 or more days, or hospitalisation/emergency department visit), was met (p<0.001).3 Primary endpoint in MUSCA, mean change from baseline in SGRQ scores at Week 24, was met (p<0.0001).4 166/936 patients (18%) had nasal polyps at screening. Mean exacerbation rates were 3.1±2.1 for patients with nasal polyps and 3.2±2.3 for patients without.2

ACO, asthma control questionnaire; CI, confidence interval; HRQoL, health-related quality of life; MICD, minimal clinically important difference; NERD, non-steroidal anti-inflammatory drug-exacerbated respiratory disease; SEA, severe eosinophilic asthma; SGRQ, St. George’s respiratory questionnaire.

REFERENCES

  1. Han JK et al. Lancet Respir Med. 2021;9:1141-1153 (supplementary)
  2. Howarth P et al. J Allergy Clin Immunol 2020;145(6):1713-1715
  3. Ortega HG et al. N Engl J Med. 2014;371(13):1198-1207
  4. Chupp G et al. Lancet Respir Med. 2017;5:390-400
  5. Han JK et al. Lancet Respir Med. 2021;9:1141-1153
  6. Juniper EF et al. Respir Med. 2005;99(5):553-558
  7. Juniper EF et al. Respir Med. 2006;100:616-621

PM-NO-MPL-WCNT-230004 June 2023