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