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Reduce OCS use
Nucala offers proven asthma control with a reduction in maintenance OCS use for your patients with severe eosinophilic asthma.1,8,9
Nucala (mepolizumab): Consistent reduction in exacerbations
Explore how Nucala consistently reduces clinically significant exacerbations in your patients with severe eosinophilic asthma across randomised control trials and real-world evidence.1-3
This is a fictional patient for illustrative purposes
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. The recommended dose of Nucala is 100mg subcutaneously (SC) once every 4 weeks in adults and adolescents 12 years and older. The licenced dose of Nucala in children aged 6-11 years is 40mg SC once every 4 weeks regardless of weight.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 (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
REALITI-A is a 2-year, international, prospective, single-arm, observational study in adults 18 years and over with severe asthma. The primary endpoint of the REALITI-A study was the rate of clinically significant exacerbations at 12 months, defined as exacerbations requiring OCS and/or hospitalisation/ED visit: 1.24/year at 12 months vs. 4.29 at baseline. ARR/year: 3.05. RR: 0.29 (95% CI: 0.26, 0.32) p<0.001).3
REALITI-A 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 is a 2-year study in adults aged 18 years and over.
The primary endpoint was the change in the rate of clinically significant asthma exacerbationsb 12 months after starting mepolizumab compared to the baseline rate in the 12 months prior to treatment1
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 hospitalisations/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.
SEA, severe eosinophilic asthma; 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 control trials.3
Nucala: Reduce exacerbations for patients with severe eosinophilic asthma and comorbid nasal polyps in a real-world setting6
Post-hoc analysis of REALITI-A and REDES real-world evidence studies
NP, nasal polyps.
Data from post-hoc analysis of the REALITI-A and REDES studies;
p-values to determine statistical significance not calculated.
REALITI-A 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 is a 2-year study in adults aged 18 years and over.
The primary endpoint was the change in the rate of clinically significant asthma exacerbationsb 12 months after starting mepolizumab compared to the baseline rate in the 12 months prior to treatment1
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.
SEA, severe eosinophilic asthma; 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
REDES Study design
| SUMMARY OF BASELINE CHARACTERISTICS | |
|---|---|
| Total population (n=318) | |
| Mean age (SD) | 56.6 (12.5) |
| Sex (%) | |
| Female | 220 (69.2) |
| BMI (kg/m2), mean (SD) | 28.59 (5.50) |
| Blood eosinophil count (cell/µL), mean (SD) | 710.2 (836.8) |
| Smoking habits (%) | |
| Never-smoker | 198 (62.3) |
| Ex-smoker (> 6 months) | 106 (33.3) |
| Smoker | 4 (1.3) |
| Age at asthma diagnosis in years, mean (SD) | 34.1 (17.9) |
| Previous omalizumab treatment (%) | 121 (38.2) |
| Co-morbidities (%) | |
| Chronic rhinosinusitis | 24% |
| Allergic rhinitis | 22% |
| Nasal polyps | 46% |
| Chronic rhinosinusitis and nasal polyposis | 11% |
DESCRIPTION: A multicentric observational cohort study of severe eosinophilic asthma (SEA) patients treated with mepolizumab across 24 specialised hospital asthma units in Spain.
OBJECTIVES: To evaluate the effectiveness and safety of mepolizumab in patients with SEA in Spain. 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 treatment. Patients were stratified by baseline blood eosinophil counts.
aMepolizumab initiation was required to have been at least 12 months before the date of inclusion in the study. Therefore, the last date for the start of treatment was set to April 2019
bData collection was intended to last 5 months, although it was extended to 8 months because of the impact of COVID-19.1
ACT: asthma control test; BEC: blood eosinophil count; COVID-19: coronavirus disease of 2019; CSE: clinically significant exacerbation; FEV1: forced expiratory volume in 1 second; mOCS: maintenance oral corticosteroid; RWE: real-world evidence; SEA: severe eosinophilic asthma
Reference:
- Domingo C, et al. Drugs. 2021;81(15):1763-1774.
- Supplementary - Domingo Ribas C;Drugs;2021;1-30
Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised control trials.3
Nucala: Consistent exacerbation reduction data for patients with severe eosinophilic asthma and comorbid nasal polyps7
Post-hoc meta-analysis of MENSA and 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) vs. 49% without nasal polyps.7
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.7
This was a post-hoc analysis and the results should be interpreted with caution.
Absolute rate reduction not calculated.
MUSCA Study design
DESCRIPTION: 24-week, multicentre, randomised, double-blind, placebo-controlled, Phase IIIb study assessing the effect of Nucala + SoC compared with placebo + SoC on disease-specific HRQoL using the SGRQ in 551 patients with severe asthma with an eosinophilic (≥150 cells/μL at baseline or ≥300 cells/μL within the last 12 months).
OBJECTIVES: Primary endpoint was the mean change from baseline in SGRQ total score at Week 24.
HRQoL, health-related quality of life; SC, subcutaneous; SGRQ, St. George’s Respiratory Questionnaire; SoC, standard of care
References:
- Chupp GL et al. Lancet Respir Med 2017; 5:390-400
MENSA Study design
DESCRIPTION: 32-week, multicentre, randomised, double-blind, double-dummy, placebo-controlled Phase III 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 ≥300 cells/μL within the last 12 months).
OBJECTIVES: Primary endpoint was the annualised frequency of clinically significant exacerbations (Systemic glucocorticoids for 3 or more days or hospitalisation/ED visit).1
Mepolizumab 75mg is not an approved dose of Nucala. Nucala is not licensed for IV administration.2
ED, emergency department; IV, intravenous; OCS, oral corticosteroid; SC, subcutaneous; SoC, standard of care
References:
- Ortega HG et al. N Engl J Med 2014; 371:1198-1207.
- Nucala SmPC
Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised control trials.3
COSMEX Study*
Nucala achieves a long term reduction in exacerbations. In the COSMEX study:
- 79% reduction in exacerbations at 3.6 years with Nucala vs. pre-treatment (n=56). ARR/year 4.17
*The data above is for patients on mepolizumab 100 mg SC. Results are descriptive.
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 control trials.1
MENSA Study
MENSA Study design
DESCRIPTION: 32-week, multicentre, randomised, double-blind, double-dummy, placebo-controlled Phase III 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 ≥300 cells/μL within the last 12 months).
OBJECTIVES: Primary endpoint was the annualised frequency of clinically significant exacerbations (Systemic glucocorticoids for 3 or more days or hospitalisation/ED visit).1
Mepolizumab 75mg is not an approved dose of Nucala. Nucala is not licensed for IV administration.2
ED, emergency department; IV, intravenous; OCS, oral corticosteroid; SC, subcutaneous; SoC, standard of care
References:
- Ortega HG et al. N Engl J Med 2014; 371:1198-1207.
- Nucala SmPC
Nucala was generally well tolerated during the trial and safety outcomes were consistent with the outcomes from randomised control trials.2
Explore the clinical data behind Nucala
Would you like to learn more about Nucala?
Footnotes
ARR, absolute rate reduction; CI, confidence interval; OCS, oral corticosteroid; ED, emergency department; RR, rate ratio
Definitions
Clinically significant exacerbations: Exacerbations requiring OCS and/or ED visits/hospitalisation.
References
- Khurana S, et al. Clin Ther. 2019;41:2041-2056
- Ortega HG, et al. N Engl J Med. 2014;371:1198–1207
- 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.
- Nucala SmPC
- Richards LB, et al. J Allergy Clin Immunol Pract. 2020;8:2999-3008.e1
- GlaxoSmithKline Data on File. REF-147645
- Howarth P, et al. J Allergy Clin Immunol. 2020;145:1713-15
- Bel EH, et al. N Engl J Med. 2014;371:1189-1197
- Lugogo N, et al. Clin Ther. 2016;38:2058-2070
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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February 2023 | PM-GB-MPL-WCNT-220003 (V2.0)
