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OCS dependent patient

The right treatment for the right patient

Nucala is the only severe eosinophilic asthma biologic proven to reduce exacerbations* and maintenance OCS for up to 4.8 years vs. baseline.†1,2,12 Nucala has demonstrated a reduction in exacerbations* and maintenance OCS in real world settings.3,4 

Nucala (mepolizumab) is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. The recommended dose of Nucala is 100mg administered subcutaneously (SC) once every 4 weeks in adults and adolescents aged 12 years and older, available in pre-filled pen, pre-filled syringe or as a lyophilised powder. The licensed dose of Nucala in children aged 6-11 years is 40mg SC regardless of weight and is available as a lyophilised powder. The pre-filled formulations are not indicated in 6-11 year olds.5

Check Nucala Eligibility

IDENTIFICATION OF APPROPRIATE SEVERE REFRACTORY EOSINOPHILIC ASTHMA PATIENTS FOR NUCALA TREATMENT

Added to standard of care†, In Ireland, Nucala is available for a sub-population of severe refractory adult asthma patients.
To identify which of your patients fall into this sub-population ensure they meet the following criteria:11

nucala-sub-population-new
  • The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's disease severity and level of control of exacerbations.5
  • †SoC - high dose ICS and additional maintenance treatment.
  • OCS;oral corticosteroids.

The right treatment for the right patient

Nucala provides reduction from exacerbations and maintenance OCS use whilst reducing eosinophils to normal levels for patients with severe eosinophilic asthma.1,6-9
Find out more below about the types of patients who could benefit from Nucala.

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frequent exacerbations patient

Meet Violet, 52 years old

Fictional patient profile

  • Asthma diagnosis at 28 years of age
  • 4 exacerbations in the past year, 2 requiring hospitalisation, no intubations
  • Eosinophil count: 428 cells/μL
  • Total IgE: 140kU/L

Find out how Nucala could reduce exacerbations in your patients

EXPLORE REAL–WORLD DATA

Nucala reduced the rate of exacerbations by 53% compared with placebo at 32 weeks in the MENSA study (Primary endpoint: 0.83 Nucala (n=194) vs. 1.74 placebo (n=191) (95% CI: 36–65) p<0.001)1

co-morbid nasal polps patient

Meet Josh, 43 years old

Fictional patient profile

  • Asthma diagnosis at 18 years of age
  • 4 exacerbations in the past year
  • Eosinophil count: 324 cells/μL
  • Presence of nasal polyps
  • Positive atopic status

EXPLORE REAL–WORLD DATA

Nucala is generally well tolerated. Very commonly or commonly reported adverse reactions in clinical trials included: headache; back pain; local injection site reactions; systemic administration-related and hypersensitivity reactions (which can occur after a long duration of treatment); LRTI; UTI; pharyngitis; nasal congestion; upper abdominal pain; eczema and pyrexia.5

OCS dependent patient

Meet Judy, 47 years old

Fictional patient profile

  • Asthma diagnosis at 29 years of age
  • 2 exacerbations in previous 12 months (outpatient, treated with high-dose OCS, 1 hospitalisation in the past year)
  • Eosinophil count: 557 cells/μL
  • Total IgE: 114kU/L
  • Currently taking OCS 12.5mg (daily, 6 months)

Explore how Nucala could allow your patients to reduce their OCS dose

EXPLORE REAL–WORLD DATA

Nucala reduced median daily OCS dose by 50% at 24 weeks in the SIRIUS study
(Secondary endpoint: 50% Nucala (n=69) (95% CI: 20.0–75.0) vs. 0% placebo (n=66) (95% CI: -20.0–33.3) p=0.007)6

Footnotes

*An exacerbation is defined as deterioration in asthma requiring use of systemic corticosteroids and/or an ED visit and/or hospital admission.

†In total, 95 patients with ≥188 weeks of continuous reporting across MENSA, COSMOS and COSMEX with ≤12 weeks between the last dose in COSMOS and first dose in COSMEX are summarised (MENSA: placebo [n=24], Nucala [n=71]). The Nucala group in MENSA contains patients on both 100mg SC and 75mg IV doses (75mg IV dose is not an approved dose of Nucala). Analyses include clinically significant exacerbations from MENSA and all exacerbations from COSMOS and COSMEX.2

Real-world studies are designed to evaluate associations among variables and not to definitively establish causality. These limitations are important when interpreting results: lack of comparator arm, differences in patient populations and data collection vs. randomised controlled trials.10

Nucala (mepolizumab) is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. The recommended dose of mepolizumab is 100mg administered subcutaneously (SC) once every 4 weeks in adults and adolescents aged 12 years and older, available in pre-filled pen, pre-filled syringe or as a lyophilised powder. The licensed dose of Nucala in children aged 6-11 years is 40mg SC regardless of weight and is available as a lyophilised powder. The pre-filled formulations are not indicated in 6-11 year olds.5

Nucala is generally well tolerated. Very commonly or commonly reported adverse reactions in clinical trials included: headache; back pain; local injection site reactions; systemic administration-related and hypersensitivity reactions (which can occur after a long duration of treatment); LRTI; UTI; pharyngitis; nasal congestion; upper abdominal pain; eczema and pyrexia.5

ICS, inhaled corticosteroid; IgE, immunoglobulin E; IL, interleukin; OCS, oral corticosteroid.

References

  1. Ortega HG et al. N Engl J Med 2014; 371:1198–1207
  2. Khurana S et al. Clin Ther 2019; 41:2041–2056
  3. Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/13993003.02345-2019) [Epub ahead of print].
  4. GlaxoSmithKline data on file. France ATU CSR REF-64557
  5. Nucala SmPC, Available from: www.medicines.ie Last Accessed: April 2023
  6. Bel EH, et al. N Engl J Med 2014; 371:1189–1197
  7. Lugogo N et al. Clinical Therapeutics 2016; 38;2058–2070
  8. Yancey SW et al. J Allergy Clin Immunol 2017; 140:1509–1518
  9. Hartl S et al. Eur Respir J 2020;1–34
  10. Leather DA, et al. Adv Ther 2020;1–21
  11. HSE's Mepolizumab (Nucala) Protocol for the treatment of severe refractory eosinophilic asthma, available on www.hse.ie. Last accessed April 2023.
  12. Khatri S, et al. J Allergy Clin Immunol. 2019;143:1742−1751

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

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PM-IE-MPL-WCNT-200016 | April 2023