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Pick section Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Severe Eosinophilic Asthma (SEA)

Eosinophilic inflammation:
a key driver of recurrent nasal polyps.1-5

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Recurrent nasal polyps and eosinophilic inflammation

How NUCALA works to target eosinophils

Eosinophil reduction with NUCALA

Role of eosinophils in health and nasal polyps

RECURRENT NASAL POLYPS AND EOSINOPHILIC INFLAMMATION

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Based on studies that examined the presence of eosinophil leukocyte infiltration in nasal polyp biopsy tissue of patients in the US and Europe.4-6

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*Retrospective study with 42 patients. Postoperative polyp recurrence was significantly higher in patients with elevated eosinophils [n=18/22 (81.8%)] than in patients with lower eosinophil levels [n=5/20 (25.0%); p=0.0001]. Eosinophil counting in nasal polyps was carried out retrospectively on histologic slides by computer-assisted image analysis software.4

HOW NUCALA WORKS TO TARGET EOSINOPHILS

Nucala is a humanised monoclonal antibody targeting IL-5.12

Interleukin-5 (IL-5) is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils.7

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EOSINOPHILIC REDUCTION WITH NUCALA

Nucala reduces blood eosinophil levels and maintains them within normal healthy levels.3,8,9,12*

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*Normal healthy levels: 30-395 eosinophils/µL (5th-95th percentile), from LEAD study: Longitudinal, observational, population based Austrian cohort. General population that had eosinophil count measured: n=11.042. Healthy sub-population: n=3641. Geometric mean value within the healthy sub-population: 107 eosinophils/µL. (95% CI: 105-110).8
łSYNAPSE 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. Other objective: On-treatment blood eosinophil count.9 Nucala, N=206; placebo, n=201. In patients with nasal polyps, Nucala reduced blood eosinophil levels by 81% at Week 4 vs. placebo, with the reduction sustained through to Week 52.3
CI, confidence interval; IL, interleukin; LS, least squares; LEAD, Lung, hEart, sociAl, boDy; SC subcutaneous.

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.

ROLE OF EOSINOPHILS IN HEALTH AND NASAL POLYPS

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Eosinophils may play a role in maintaining health by helping:10,11

  • to regulate the immune system
  • to defend the body from pathogens

Elevated eosinophils in nasal polyps are associated with:1-4

  • inflammation
  • greater likelihood of nasal polyp recurrence following surgical removal

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SAFETY

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Efficacy

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Dosing & Administration

REFERENCES

  1. Bachert C et al. J Allergy Clin Immunol. 1997;99(6.1):837–842.
  2. Bachert C et al. J Allergy Clin Immunol. 2001;107(4):607–614.
  3. Han JK et al. Lancet Respir Med. 2021; 9:1141-1153
  4. Tosun F et al. Ann Otol Rhinol Laryngol. 2010;119(7):455-459.
  5. Lou H et al. Rhinology. 2016;54:150–159.
  6. Fujieda S et al. Allergol Int. 2019;68(4):403–412.
  7. Trivedi SG et al. Cell Mol Life Sci. 2007;64(10):1269-1280
  8. Hartl S et al. Eur Respir J. 2020;55(5):1901874.
  9. Han JK et al. Lancet Respir Med. 2021; 9:1141-1153 (Supplementary)
  10. Weller PF et al. Nat Rev Immunol. 2017;17(12):746-760.
  11. Wen T et al. Microbiol Spectr. 2016;4 doi: 10.1128/microbiolspec. MCHD-0020-2015.)
  12. Nucala preparatomtale

Nucala is a trademark of the GSK group of companies

PM-NO-MPL-WCNT-230003 June 2023