This page contains real world evidence. This is a real patient with eosinophilic asthma, compensated by GSK for his time.
The right treatment for the right patient

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older¹

This page contains real world evidence. This is a real patient with eosinophilic asthma, compensated by GSK for his time.

The recommended dose of Nucala is 100mg SC once every 4 weeks in adults and adolescents 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.¹

The recommended dose of Nucala is 100mg SC once every 4 weeks in adults and adolescents 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.¹

Are your patients eligible for Nucala?

SUMMARY OF NICE GUIDANCE TA431
ELIGIBILITY CRITERIA IN ENGLAND AND WALES²
 

Blood eosinophils ≥ 300 cells/ µl (0.3 x 10⁹/ L) in the previous 12 months


≥ 4 exacerbations needing systemic corticosteroids in the previous 12 months
OR
 Continuous OCS equivalent to 5 mg prednisolone/ day over previous 6 months

SUMMARY OF SMC GUIDANCE

ELLIGIBILITY CRITERIA IN SCOTLAND³
 

Blood eosinophils ≥ 150 cells/ µl (0.15 x 10⁹/ L) at initiation


≥ 4 exacerbations in the previous 12 months
OR
Receiving maintenance treatment with OCS

The right treatment for the right patient

Choose Nucala: the only anti-IL-5 that protects against exacerbations, whilst reducing blood eosinophils to normal levels.² ⁴⁻⁸

REALITI-A interim analysis. 69% reduction in exacerbations. (n=367) Rate ratio: 0.31 CI: 0.27–0.35 4.63 at baseline (over the previous 12 months) vs.1.43 at 12 months, p<0.001. Exacerbation rate at 12 months. Study limitations: These data are a prespecified interim analysis of 368 patients who completed 12 months of follow-up as of February 2019. This analysis may not reflect the results from the final dataset.⁸
The normal range is based on 5th – 95th percentile values from the general population. The normal range of eosinophils in healthy individuals is 30 – 395 cells/µL⁴. n=3,641. Data represented 95% confidence intervals.

Find out more below about the types of patients who could benefit from Nucala.

Violet, 50 years old

Meet Violet, 50 years old

"I'm really worried that I'll have another asthma attack - what if it happens in the pool?"

Fictional patient profile for illustrative purposes only

  • Asthma diagnosis 15 years ago
  • 4 exacerbations in the past year
  • Eosinophil count: 400 cells/μL
  • Total IgE: 140kU/L
  • Maintenance ICS/LABA, 2 puffs BD
  • FEV1 % predicted: 62%

Find out how Nucala could reduce exacerbations in your patients

Nucala reduced the rate of exacerbations by 53% compared to placebo at 32 weeks in the MENSA study (Primary endpoint: 0.83/year (n=194) vs. 1.74/year (n=191) (95% CI: 36–65) p<0.001)³

Judy, 47 years old

Meet Judy, 47 years old

"I'm worried about the side effects of steroids - I've already gained weight."

Fictional patient profile for illustrative purposes only

  • Asthma diagnosis 7 years ago
  • 2 exacerbations last year
  • Eosinophil count: 300 cells/μL
  • Total IgE: 114kU/L
  • Maintenance OCS
  • FEV1 % predicted: 58%
  • High-dose maintenance ICS/LABA, 2 puffs BD

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

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)⁹. The primary endpoint, the percentage reduction in maintenance OCS dose whole maintaining asthma control, was met.

Sara, 10 years old

Meet Sara, 10 years old

"I hate that I can't play outside with my friends because my mum is worried about my asthma attacks."

Fictional patient profile for illustrative purposes only

  • Asthma diagnosis 5 years ago
  • 4 exacerbations in the past year, one leading to an ED visit
  • Eosinophil count: 340 cells/μL
  • Total IgE: 148kU/L
  • FEV1 % predicted: 65%
  • High paediatric dose ICS/LABA, 2 puffs BD

Nucala is the first and only biologic indicated from age 6¹

The licensed dose of NUCALA in children aged 6–11 years is 40mg SC regardless of weight.¹

Footnotes

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

†The maximum exposure duration of mepolizumab in the phase 3 and open label extension studies was 4.8 years. A patient withdrawal range of 4 weeks to 4.8 years was observed in MENSA, SIRIUS, COSMOS and COSMEX.

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.⁹

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.¹

Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within the first 3 injections.¹ The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.⁵

The recommended dose of Nucala is 100mg SC once every 4 weeks in adults and adolescents 12 years and older, available in a pre-filled pen, pre-filled syringe or lyophilised powder. The licensed dose of Nucala in children aged 6–11 years is 40mg SC regardless of weight and available in lyophilised powder. The pre-filled formualations are not indicated in 6-11 year olds.¹

ED, emergency department; IgE, immunoglobulin E; IL, interleukin; OCS, oral corticosteroid; SC, subcutaneous; BD, twice daily.

References

  1. Nucala SmPC, 2020
  2. Lugogo N et al. Clinical Therapeutics 2016; 38;2058-2070
  3. Ortega HG et al. N Engl J Med 2014; 371:1198-1207
  4. Hartl S et al. Eur Respir J 2020;1-21
  5. Khurana S et al. Clin Ther 2019; 41:2041-2056
  6. Denlinger LC et al. Am J Respir Crit Care Med 2017; 195:302-313.
  7. Felarca AB et al. J Allergy 1967; 40:16-20.
  8. GlaxoSmithKline data on file. REF-74585
  9. Leather DA et al. Adv Ther 2020;1-21

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441

© 2020 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

PM-GB-MPL-WCNT-200027 | November 2020