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Reduce exacerbations
For patients with severe eosinophilic asthma, Nucala helps to reduce exacerbations, including those requiring hospitalisations.2,3,8
Nucala (mepolizumab) OCS reduction data
Explore how Nucala can help alleviate the burden of steroids for your patient with severe eosinophilic asthma.1-4
This is a fictional patient for illustrative purposes
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 (based on a real-world evidence study including 119 patients treated with Nucala).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.3
REALITI-A 2-year Results
The primary endpoint of the REALITI-A study was a reduction in clinically significant exacerbations at 12 months. The primary endpoint was met.3
Median maintenance OCS dose reduced from 10.0mg/day (range: 15.0-5.0 mg/day) at baseline to 0.0mg/day at 2 years (range: 5.0-0.0mg/day).3
REALITI-A Study Design
Study Design: 2-years, global, prospective, observational, single-arm study1
| SUMMARY OF BASELINE characteristics | |
|---|---|
| Total population (n=822) | |
| Age in years, mean (SD) | 54.0 (13.6) |
| Female % | 63% |
| Smoking history | |
Current smoker % |
3% |
Never smoked % |
62% |
Former smoker % |
36% |
| Geometric mean blood eosinophil count, cells/μL (SD log) | 350 (1.253) |
| Mean duration of asthma in years (SD) | 19.7 (15.7) |
| Patients on maintenance OCS & | 39% |
| Daily mean OCS dose in mg/day (IQR) | 10 (5.0, 15.0) |
| Comorbidities % | |
Allergic Rhinitis |
49% |
Chronic Rhinosinusitis |
40% |
Nasal Polyps |
39% |
REALITI-A was a 2-year study in adults aged 18 years and over.
The primary endpoint was the change in the rate of clinically significant asthma exacerbations 12 months after starting mepolizumab compared to the baseline rate in the 12 months prior to treatement.1
Secondary endpoints included the rate of clinically significant exacerbations at 24 months post-exposure, the reduction in daily OCS dose from pre-treatment to 24 months post-exposure, exacerbations requiring hospiitalisations/ED visits, exacerbations requiring hospitalisations and safety: AEs and SAEs.1
aIf enrolment occurred before the index date, there was a variable-length run-in period in which patients continued with the same therapy; there was no run-in period when enrolment and index dates were the same day/when index date occurred before enrolment2; bClinically significant exacerbations: those requiring ED visit/hospitalisation and/or use/increased dose of OCS therapy2
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.
SC, subcutaneous; SoC, standard-of-care.
References:
- Caruso C, Canonica GW, Patel M, et al. International, prospective study of mepolizumab in severe asthma: REALITI-A at 2yrs. Abstract presented at ERS; 4-6 September 2022; Barcelona, Spain.
- Harrison T, et al. Eur Respir J. 2020;56:2000151;
Nucala was generally well tolerated during the study and safety outcomes were consistent with the outcomes from randomised controlled trials.3
COSMEX Study*
Nucala provides your patients with severe eosinophilic asthma long-term reduction in OCS use.2
- Up to 88% reduction in median OCS dose vs. Baseline at approximately 2.5 years
- Nucala (n=20): OCS dose at Baseline, 11.3 mg/day vs. 1.3 mg/day at Week 128
*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.6 These limitations are important when interpreting results: lack of comparator arm, differences in patient population and data collection vs. randomised control trials.7
COSMEX Study design
DESCRIPTION: Multi-centre, open-label, long-term, single arm extension study assessing the safety and efficacy of Nucala in 339 patients with severe eosinophilic asthma who were given Nucala 100mg SC every 4 weeks in addition to SoC. COSMEX enrolled a subset of patients from COSMOS with a history of life-threatening or seriously debilitating asthma. There was no fixed treatment duration for COSMEX and all patients were given Nucala until they met protocol-defined stopping criteria. The median duration of Nucala treatment in COSMEX was 2.2 years (range 8 weeks-3.3 years); maximum exposure to Nucala for patients in COSMEX was up to 4.8 years.
OBJECTIVES: The primary endpoints were adverse event frequency and annualised rate of exacerbations. FEV1, ACQ-5 score and daily OCS use were also assessed.
ACQ-5, asthma control questionnaire; FEV1, forced exhalation volume in one second; OCS, oral corticosteroid; SC, subcutaneous; SoC, standard of care
*As determined by the investigator
Reference:
- Khurana, S. Clinical Therapeutics; 2019; 1-16.e5;doi.org/10.1016/j.clinthera.2019.07.007
Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised controlled trials.2
SIRIUS Study
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).
- The median percentage reduction from baseline in the glucocorticoid dose was 50% in the mepolizumab group, as compared with no reduction in the placebo group (p= 0.007).4
Description: 24-week, multicentre, 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). Patients were on 5 to 35mg of prednisone or its equivalent per day for the prior 6 months, in addition to regular use of high-dose ICS plus an additional controller. Patients were not required to have a history of exacerbations in the previous 12 months.
Primary endpoint: Primary endpoint was the percent reduction in daily OCS dose (Weeks 20 to 24) while maintaining asthma control.
ICS, inhaled corticosteroid; OCS, oral corticosteroid; SC, subcutaneous
References:
- Bel EH et al. N Engl J Med 2014; 371:1189-1197.
Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised controlled trials.4
Explore the clinical data behind Nucala
Would you like to learn more about Nucala?
Footnotes:
mOCS: maintenance oral corticosteroids; OCS: oral corticosteroids;
References:
- Domingo C, et al. Drugs. 2021;81(15):1763-1774
- Khurana S, et al. Clinical therapeutics. 2019;41(10) 2041-2056.e5
- Caruso C, Canonica GW, Patel M, et al. International, prospective study of mepolizumab in severe asthma: REALITI-A at 2yrs. Abstract presented at ERS; 4-6 September 2022; Barcelona, Spain.
- Bel EH, et al. N Engl J Med. 2014;371:1189-1197
- Richards LB, et al. J Allergy Clin Immunol Pract. 2020;8:2999-3008.e1
- 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: October 2022.
- GlaxoSmithKline Data on File; REF-101687
- Ortega HG, et al. N Engl J Med. 2014;371(13):1198-1207
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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December 2022 | PM-GB-MPL-WCNT-220002 (V2.0)
