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Nucala (mepolizumab) OCS reduction data

Nucala offers proven asthma control and can help reduce OCS use for your patients with severe eosinophilic asthma1,2

This is a fictional patient for illustrative purposes

Nucala: Sustained reduction in median maintenance OCS in the real-world setting3,4

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.5

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.6

12 month post-exposure interim analysis

Line graph showing the reduction in median daily OCS dose at 1 year vs. Baseline with Nucala. At Baseline, the median daily OCS dose was 10.0mg/day (n=298). At Week 52, the median OCS dose was 2.5mg/day. This demonstrated a 75% reduction in OCS dose with Nucala. There  is a text box stating that 43% (n=95/222) of subjects discontinued daily mOCS at 1 year.

*The primary endpoint of the REALITI-A study is a reduction in clinically significant exacerbations. The primary endpoint was met.

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 controlled trials.

Nucala: Long-term reduction in OCS use7

COSMEX Study*

Bar chart showing long-term reduction in OCS use with Nucala. At baseline, the median OCS dose was 11.3 mg/day and at Week 128 with Nucala, the median OCS dose was 1.3 mg/day. This demonstrates a reduction of up to 88% dose vs. baseline at approximately 2.5 years.6

Nucala provides your patients with severe eosinophilic asthma long-term reduction in OCS use.7

  • Up to 88% reduction in median OCS dose vs. Baseline at approximately 2.5 years7
    • Nucala (n=20): OCS dose at Baseline, 11.3 mg/day vs. 1.3 mg/day at Week 1287

*Includes participation in MENSA (32 weeks) or SIRIUS (24 weeks; treatment for 20 weeks) and COSMOS (52 weeks; treatment for 48 weeks) prior to inclusion in COSMEX (up to 172 weeks).
**OCS use throughout the SIRIUS (24 weeks), COSMOS (52 weeks), and COSMEX (up to 172 weeks) studies in patients with ≥ 128 weeks continuous enrolment. Patients included from SIRIUS were required to have a reduction in OCS dose by ≥ 50% compared with the patient's optimised OCS dose at randomisation in SIRIUS, during SIRIUS for those randomised to mepolizumab, and during the first 6 months of COSMOS for those randomised to placebo.8 These limitations are important when interpreting results: lack of comparator arm, differences in patient population and data collection vs. randomised control trials.9

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 controlled trials.

Nucala: Proven reduction in OCS dose1

SIRIUS Study

Bar chart showing daily OCS reduction with Nucala. There was a 50% reduction in daily OCS dose from Baseline, while maintaining asthma control, for patients with Nucala (n=69), vs. 0% reduction with placebo (n=66).1

The primary endpoint in SIRIUS, percentage reduction in daily OCS dose during Weeks 20-24 compared to the baseline dose, was met (p=0.008).

  • 50% reduction in median daily OCS dose from Baseline while maintaining asthma control was achieved for patients treated with Nucala, compared to 0% reduction with placebo1
Diagrammatic representation of SIRIUS study design. 24-week, multi-centre, randomised, double-blind, placebo-controlled, Phase III study to investigate the efficacy and safety of Nucala in reducing OCS use while maintaining asthma control. Treatment with Nucala was compared with placebo in 135 patients with severe asthma with an eosinophilic phenotype (≥150 cells/μL at baseline or ≥300 cells/μL  in the past 12 months).

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

Explore the clinical data behind Nucala

Footnotes:

mOCS: maintenance oral corticosteroids; OCS: oral corticosteroids; RWE: real-world evidence

References:

  1. Bel EH, et al. N Engl J Med. 2014;371:1189-1197
  2. Lugogo N, et al. Clin Ther. 2016;38:2058-2070
  3. Taillé C, et al. Eur Respir J. 2020;55: 1902345
  4. GlaxoSmithKline data on file. REF-129375
  5. Richards LB, et al. J Allergy Clin Immunol Pract. 2020;8:2999–3008.e1
  6. Pilette C, et al. ERS 2021: Poster#3539
  7. Khurana S et al. Clin Ther. 2019;41:2041-2056
  8. National Institute for Health and Care Excellence (NICE) - Final Appraisal Document Mepolizumab [TA671; 3 Feb 2021]. Accessed via: Mepolizumab for treating severe eosinophilic asthma (nice.org.uk). Last accessed: June 2022.
  9. GlaxoSmithKline Data on File; REF-101687
  10. Ortega HG, et al. N Engl J Med. 2014;371:1198-1207
  11. Chupp GL, et al. Lancet Respir Med. 2017;5:390-400

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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June 2022 | PM-GB-MPL-WCNT-220002 (V1.0)