This is real life

Real-world studies now prove the efficacy (exacerbation and OCS reduction compared to baseline) of Nucala in everyday practice.¹ ²

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

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.³

Nucala provides a real-life reduction in exacerbations and maintenance OCS vs. baseline whilst reducing eosinophils to normal levels¹ ² ⁴⁻⁶

Nucala reduced the rate of exacerbations* by 53% compared with placebo at 32 weeks in MENSA randomised control trial (Primary endpoint: 0.83 Nucala (n=194) vs. 1.74 placebo (n=191) (95% CI: 36–65) p<0.001).⁷

Nucala reduced median daily OCS dose by 50% at 24 weeks in SIRIUS randomised control trial (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).⁸

In the 24-week Phase III study, SIRIUS, the secondary outcome of total cessation in OCS use was not significant (N (%); Nucala 10/69 (14%) vs. 5/66 (8%) placebo p=0.41). However, the protocol did not allow for patients on higher doses (25mg/day or more) to be weaned completely.⁸

REALITI-A real-world study

REALITI-A is an interim analysis of the early initiators with 12 months of data.

Ratio rate: 0.31 CI:0.27-0.35 p<0.001

Baseline | 4.63 (over previous 12 months)

At 12 months | 1.43 with Nucala

95% CI: 50-75

Baseline | 10mg

At 12 months | 5mg

† 52% is the median percent reduction from baseline in average daily dose of maintenance OCS
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.

COSMEX long term study

Baseline | 11.3 mg/day

Week 128 | with Nucala 1.3 mg/day
 

COSMEX (4.8 year study) 88% reduction in OCS dose vs. baseline at 2.5 years. Results are descriptive.
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.

Nucala reduces blood eosinophils to normal levels⁴ ⁶ ⁹⁻¹¹

Nucala reduces blood

*The normal range is based on 5th – 95th percentile values from the general population¹² The normal range of eosinophils in healthy individuals is 30 - 395 cells/uL⁶
**Geometric mean value from COSMOS study (n=590; SD logs 0.934). This is a 52-week open-label extension study in patients who received Nucala or placebo in MENSA or SIRIUS

Nucala: Mechanism of action

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Nucala: The power to choose at home or in clinic administration³

Nucala offers at-home administration that lets appropriate patients self-administer without the need to come into the clinic or hospital. Nucala is the only 4 weekly asthma biologic with a simple fixed dose.³

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, prefilled 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.

Identify and support patients with severe eosinophilic asthma

Identify patients with elevated eosinophil levels that are eligible for Nucala

Support for you and your patients when starting treatment with Nucala

Footnotes

*Defined as deterioration in asthma requiring use of systemic corticosteroids and/or an ED visit and/or hospital admission.

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.²¹ France ATU (cohort of patients in France) was a retrospective observational study.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%, respectively), which occurred mainly within the first three injections.³

The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.⁹

References

  1. Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/13993003.02345-2019)
  2. GlaxoSmithKline data on file. REALITI-A CSR. REF-56226
  3. Nucala SmPC, 2020
  4. Lugogo N et al. Clinical Therapeutics 2016; 38;2058–2070
  5. Yancey SW et al. J Allergy Clin Immunol 2017; 140:1509–1518
  6. Hartl S et al. Eur Respir J 2020; 1–34
  7. Ortega HG et al. N Engl J Med 2014; 371:1198–1207
  8. Bel EH et al. N Engl J Med 2014; 371:1189–1197
  9. Khurana S et al. Clin Ther 2019; 41:2041–2056
  10. Delinger LC et al. Am J Respir Crit Care Med 2017; 195:302-313
  11. Felarca AB et al. J Allergy 1967; 40:16-20
  12. GlaxoSmithKline data on file. FRANCE ATU CSR. REF-64557
  13. Steinfield J et al. Am J Respir Crit Care Med 2019; 199:A7192

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

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PM-GB-MPL-WCNT-200015 | November 2020