You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site.

Continue

Go back

Nucala demonstrated a reduction in exacerbations* and maintenance OCS in the real world setting.**1,2

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).

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

Nucala: Real-life reduction in exacerbations¹ ²

Real-world evidence: Exacerbation reduction in the France ATU study1
Exacerbation 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.

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
Exacerbation reduction in the REALITI-A study
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

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.

Nucala: Associated with sustained reduction in exacerbations⁶

Long-term data: Exacerbation reduction in the COSMEX study (n=340)6
Exacerbation reduction in the COSMEX study
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 of Nucala).
Analyses include clinically significant exacerbations from MENSA and all exacerbations from COSMOS and COSMEX.

Nucala: Proven reduction in exacerbations³

Clinical trial data: Exacerbation reduction in the MENSA trial3
Exacerbation reduction in the MENSA trial
100% reduction in exacerbations in 6.7/10 patients
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).

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
Post hoc meta-analysis

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.

Nucala: Associated with real-life protection from maintenance OCS¹ ²

Real-world evidence: Proportion of patients without maintenance OCS in the France ATU study1
Proportion of patients without maintenance OCS in the France ATU study

Patients free from maintenance OCS

Real-world evidence: OCS dose reduction in the France ATU study
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
OCS dose reduction in the REALITI-A study
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.

52% is the median percent reduction form baseline in average daily dose of maintenance OCS.

Nucala: long-term reduction in OCS dose⁶

Long-term data: OCS reduction in the COSMEX study6
OCS reduction in the COSMEX study
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 of Nucala). Analyses include clinically significant exacerbations from MENSA and all exacerbations from COSMOS and COSMEX.

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 (primary endpoint).

SIRIUS trial OCS reduction
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. Very commonly or commonly reported adverse reactions in clinical trials included: headache; back pain; local injection site reactions; systemic administration-related and hypersensitivity reactions (which can occur after a long duration of treatment); LRTI; UTI; pharyngitis; nasal congestion; upper abdominal pain; eczema and pyrexia.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; OCS, oral corticosteroid; RCT, randomised controlled trial; SC, subcutaneous; SEA, Severe eosinophilic asthma.

References

  1. Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/1399 3003.02345-2019) [Epub ahead of print]
  2. GlaxoSmithKline data on file. REF-74585
  3. Ortega HG et al. N Engl J Med 2014; 371:1198–1207
  4. Bel EH et al. N Engl J Med 2014; 371:1189–1197
  5. Nucala SmPC, Available from: www.medicines.ie Last accessed: March 2020
  6. Khurana S et al. Clin Ther 2019; 41:2041–2056
  7. GlaxoSmithKline data on file. REF-74585
  8. Chupp GL et al. Lancet Respir Med 2017; 5:390–400
  9. Leather DA, et al. Adv Ther. 2020;1–21

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

© 2021 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.

PM-IE-MPL-WCNT-200014 | March 2021