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In the meantime, you can enjoy access to all the latest news, events and resources on our websiteNucala: Powerful and lasting reduction in exacerbations and OCS dose, supported by real life studies¹⁻⁴,⁶
MENSA: (32 weeks): Nucala provided a 53% reduction in the rate of exacerbations* compared with placebo. (0.83 Nucala (n=194) vs.1.74 placebo (n=191) [95% CI: 36–65] p<0.001. This was the primary endpoint).³
SIRIUS: (24 weeks secondary endpoint) Nucala provided a 50% reduction in OCS dose compared to placebo (p=0.007, 50% reduction with Nucala [95% CI 20.0–75.0], n=69 vs. 0% reduction with placebo [95% CI -20.0–33.3], n=66).⁴
Nucala: Proven protection from exacerbations³
Clinical trial data: Exacerbation reduction in the MENSA trial3
Real-world evidence: Exacerbation reduction in the France ATU study1
Please see full study description for FRANCE ATU
France ATU (cohort of patients in France) was a retrospective observational study.1
Results are descriptive.
Please see full study description for FRANCE ATU
France ATU (cohort of patients in France) was a retrospective observational study.1
Results are descriptive.
Real-world evidence: Exacerbation reduction in the REALITI-A study2
Please see full study description for REALITI-A
Study limitations: 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.
Please see full study description for REALITI-A
Pre-treatment refers to 12-month pre-Nucala treatment.
Study limitations: 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.
Long-term data: Exacerbation reduction in the COSMEX study (n=340)6
Please see full study description for COSMEX
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.
Please see full study description for COSMEX
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/route of administration of Nucala).
Analyses include clinically significant exacerbations from MENSA and all exacerbations from COSMOS and COSMEX.⁶
Pre-treatment refers to the 12 months before enrollment in MENSA.⁶
Please see full study description for MENSA
Results are descriptive. This was a post hoc analysis and results should be interpreted with caution. Nucala (n=130; 67%; 6.7/10 patients) vs. placebo (n=86; 45%; 4.5/10 patients).
Nucala: Proven reduction in asthma exacerbations in patients with severe eosinophilic asthma with co-morbid nasal polyps⁸
MENSA (32 weeks)/MUSCA (24 weeks) post hoc meta-analysis8
Results are descriptive.
Nucala is not licensed for the treatment of nasal polyps. This was a post hoc analysis and the results should be interpreted with caution.
This was a post hoc meta-analysis (MENSA and MUSCA) of data from patients who received ≥ 1 dose of mepolizumab 100 mg SC or placebo. Eligible patients were ≥12 years of age with SEA and a history of ≥ 2 exacerbations in the previous 12 months despite using high-dose inhaled corticosteroids and ≥ 1 additional controller.
The primary endpoint was the annual rate of clinically significant exacerbations (asthma worsening requiring systemic corticosteroids and/or hospitalisation and/or an ED visit). Nasal polyps reported by patient and assessed by investigator at baseline.⁸
Nucala: Proven reduction in OCS dose⁴
Clinical trials: SIRIUS trial OCS reduction (n=135)4
More patients with Nucala than placebo had a reduction of 90 to 100% in OCS dose (23% vs. 11%) and a reduction of 70 to less than 90% (17% vs. 8%) in the SIRIUS trial at 20 to 24 weeks (primary endpoint).
Patients free from maintenance OCS
Real-world evidence: OCS dose reduction in the France ATU study
Please see full study description for FRANCE ATU
France ATU (cohort of patients in France) was a retrospective observational study.1
Results are descriptive.
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.4
Please see full study description for FRANCE ATU
France ATU (cohort of patients in France) was a retrospective observational study.1
Results are descriptive.
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.4
Real-world data: OCS dose reduction in the REALITI-A study2
Please see full study description for REALITI-A
Study limitations: 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.
52% is the median percent reduction form baseline in average daily dose of maintenance OCS.
Please see full study description for REALITI-A
Study limitations: 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.
Please see full study description for COSMEX
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.
Please see full study description for COSMEX
In total, 38 patients with ≥ 128 weeks of continuous reporting across SIRIUS, COSMOS, and COSMEX with ≤12 weeks between the last dose in COSMOS and first dose in COSMEX are summarized (SIRIUS, placebo, n = 18; mepolizumab, n = 20). Data are summarized in terms of prednisone equivalent dose.⁶
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Footnotes
*An exacerbation is 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.⁹
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.⁵
The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.⁶
ATU, Temporary Authorization for Utilization; CI, confidence interval; ED, emergency department; IL, interleukin; IV, intravenous; OCS, oral corticosteroid; RCT, randomised controlled trial; SC, subcutaneous; SEA, Severe eosinophilic asthma.
References
- Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/1399 3003.02345-2019)
- Harrison T. et al. ERS 2019;oral presentation;1-16.
- Ortega HG et al. N Engl J Med 2014; 371:1198–1207
- Bel EH et al. N Engl J Med 2014; 371:1189–1197
- Nucala SmPC
- Khurana S et al. Clin Ther 2019; 41:2041–2056
- GlaxoSmithKline data on file. REF-74585
- Chupp GL et al. Lancet Respir Med 2017; 5:390–400
- Leather DA, et al. Adv Ther. 2020;1–21
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PM-BE-MPL-WCNT-200042 - August 2020
