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Nucala (mepolizumab) exacerbation reduction data

Explore how Nucala can reduce clinically significant exacerbations in your patients with severe eosinophilic asthma1-3

This is a fictional patient for illustrative purposes

Nucala: Proven reduction in clinically significant exacerbations in a real-world setting3

82.4% of severe asthma patients prescribed Nucala in real world practice would have been ineligible to participate in Nucala clinical trials due to the inclusion criteria.4

In contrast to traditional randomised control trials, the real world evidence REALITI-A study had broad inclusion criteria to best represent the severe asthma patients you see in your clinics.3

REALITI-A 12 month post-exposure interim analysis

Bar chart showing the mean annualised rate of clinically significant exacerbations, including those requiring hospitalisation/ED visits. The chart demonstrates a 71% reduction in clinically significant exacerbations at 1 year vs. baseline. The graph also  demonstrates a 76% reduction in exacerbations requiring hospitalisation/ED visits at 1 year vs. baseline.3

Adapted from Pilette C et al. 2021

Nucala reduces clinically significant exacerbations. In a recent real-world study:

  • 71% reduction in clinically significant exacerbations at 1 year vs. baseline3
    • Clinically significant exacerbations reduced from 4.28 pre-treatment (n=821) to 1.23 in the 12 months post-treatment (n=820); p<0.001.3
  • 76% reduction in exacerbations requiring hospitalisations/ED visits at 1 year vs. baseline3
    • Secondary endpoints: exacerbations requiring hospitalisation/ED visits reduced from 0.95 visits/year during the pre-treatment period (n=821) to 0.23 visits/year in the 12 months post-treatment (n=820); p<0.0013

REALITI-A is an ongoing 2-year study in adults aged 18 years and over. The graph reports on the 1-year interim results which may not reflect the results from the final dataset.

Diagrammatic representation of REALITI-A study design. Multinational, prospective, single-arm, 2 year, observational cohort study assessing the effectiveness and pattern of use of Nucala 100mg every 4 weeks in adult patients with severe eosinophilic asthma in real-world clinical practice. A table summarising baseline characteristics of the subjects enrolled shows factors such as mean age, geography and co-morbidities amongst other attributes.

Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised control trials.

Nucala: Reduce exacerbations for patients with severe eosinophilic asthma and comorbid nasal polyps5

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

Forest plot demonstrating a post-hoc meta-analysis of MENSA/MUSCA on the rate of exacerbation reduction in severe eosinophilic asthma and severe eosinophilic asthma with comorbid nasal polyps.5

In a post-hoc meta-analysis of MENSA/MUSCA:

80% reduction in clinically significant exacerbations in patients with severe eosinophilic asthma and comorbid nasal polyps (rate ratio 0.2 (95% CI 0.11-0.35) n=166).5

A post-hoc meta-analysis of the MENSA and MUSCA studies (n=936) was conducted, comparing the efficacy of Nucala vs. placebo in patients with severe eosinophilic asthma and patient-reported co-existing airway comorbidities (including nasal polyps, aspirin/non-steroidal inflammatory drug intolerance or both). At baseline, 166 patients reported co-morbid nasal polyps, 87 reported co-morbid aspirin/non-steroidal inflammatory drug intolerance and 40 had reported both. Nucala reduced clinically significant exacerbations vs. placebo in patients with and without each comorbidity; the greatest improvement was seen in patients with nasal polyps.5

This was a post-hoc analysis and the results should be interpreted with caution.
Absolute rate reduction not calculated.

Diagrammatic representation of MUSCA study design. 24-week, multicentre, randomised, double-blind, placebo-controlled, Phase IIIb study assessing the effect of Nucala compared with placebo added to SoC on disease specific HRQoL using the SGRQ in 551 patients with severe asthma with an eosinophilic phenotype (≥150 cells/µL at baseline or ≥ cells/µL within the last 12 months).1
Diagrammatic representation of MENSA study design. 32-week, multicentre, randomised, double-blind, double-dummy, placebo-controlled Phase 3 study comparing treatment with Nucala 100mg SC or mepolizumab 75mg IV to placebo, each added to SoC in 576 patients with severe asthma with an eosinophilic phenotype (≥150 cells/µL at baseline or ≥ cells/µL within the last 12 months).

Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised control trials.

Nucala: Long-term reduction in exacerbation rates7

COSMEX Study*

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.6

Nucala achieves a long term reduction in exacerbations. In the COSMEX study:

  • 80% reduction in exacerbations at 3.6 years with Nucala vs. pre-treatment (n=95). Absolute rate/year reduction 4.04.7

*Defined as worsening of asthma that requires systemic corticosteroids, hospitalisation or an ED visit. The mepolizumab group in MENSA contains patients on both 100mg SC and 75mg IV doses. The licensed dose for mepolizumab in adults and adolescents aged 12 years or older is 100mg SC once every 4 weeks. Mepolizumab 75mg IV is an unlicensed dose. Results are descriptive.

Diagrammatic representation of COSMEX study design. Treatment period of up to 172 weeks and N=339.

Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised control trials.

Nucala: Reduce exacerbations requiring hospitalisation1-3

MUSCA Study

Bar chart showing the mean annualised rate of asthma exacerbations requiring hospitalisation/ED visits. The chart demonstrates a reduction of up to 68% in exacerbation rate vs. placebo.1

Adapted from Chupp GL et al. 2017 

The primary endpoint in MUSCA, change in SGRQ total score from baseline was met (p<0.0001).1

  • 68% reduction in rate of exacerbations requiring hospitalisation/ED visits vs. placebo1
  • Additional endpoint: exacerbations requiring hospitalisation/ED visits: 0.03/year with Nucala (n=274) vs. 0.1/year with placebo (n=277). Treatment difference: 0.32 (95% CI: 0.12, 0.90; p=0.031)1
Diagrammatic representation of MUSCA study design. 24-week, multicentre, randomised, double-blind, placebo-controlled, Phase IIIb study assessing the effect of Nucala compared with placebo added to SoC on disease specific HRQoL using the SGRQ in 551 patients with severe asthma with an eosinophilic phenotype (≥150 cells/µL at baseline or ≥ cells/µL within the last 12 months).1

Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised control trials.

Explore the clinical data behind Nucala

Footnotes

CI, confidence interval; OCS, oral corticosteroid; ED emergency department

References

  1. Chupp GL, et al. Lancet Respir Med. 2017;5:390–400
  2. Ortega HG, et al. N Engl J Med. 2014;371:1198–1207
  3. Pilette C, et al. ERS 2021: Poster#3539
  4. Richards LB, et al. J Allergy Clin Immunol Pract. 2020;8:2999-3008.e1
  5. Howarth P, et al. J Allergy Clin Immunol. 2020;145:1713-15
  6. Nucala SmPC
  7. Khurana S, et al. Clin Ther. 2019;41:2041-2056
  8. Bel EH, et al. N Engl J Med. 2014;371:1189-1197
  9. Lugogo N, et al. Clin Ther. 2016;38:2058-2070

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July 2022 | PM-GB-MPL-WCNT-220003 (V1.0)