Nucala demonstrated a reduction in exacerbations and maintenance OCS in the real world setting¹ ²

MENSA (32 week randomised control trial) 53% reduction in exacerbations* vs. placebo: NUCALA 0.83/year (n=194) vs. placebo 1.74/year (n=191) (95% CI: 36–65) p<0.001. This was the primary endpoint.³

SIRIUS randomised control trial secondary endpoint: Median daily OCS dose reduction. 50% NUCALA (n=69) (95% CI: 20.0–75.0) vs. 0% placebo (n=66) (95% CI: -20.0–33.3) (p=0.007).⁴ The primary endpoint, the percentage reduction in maintenance OCS dose while maintaining asthma control, was met.⁴

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.⁵

The recommended dose of Nucala is 100mg SC once every 4 weeks in adults and adolescents 12 years and older, available in pre-filled pen, pre-filled syringe or as a lyophilised powder. The licensed dose of Nucala in children aged 6– 11 years is 40mg SC regardless of weight, and is available as a lyophilised powder.⁵ The pre-filled formulations are not indicated in 6-11 year olds.⁵

Nucala: Associated with real-life reduction in exacerbations¹ ²

Real-world evidence: Reduction in exacerbations in the REALITI-A study²
Alternative Text
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.

Real-world evidence: Reduction in exacerbations in France ATU study¹
Please see full study description for FRANCE ATU

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.

France ATU (cohort of patients in France) was a retrospective observational study.¹
Results are descriptive. Statistical significance was not achieved.

Nucala: Associated with sustained reduction in exacerbations⁶

Long-term data: Exacerbation reduction in the COSMEX study (n=340)6
Please see full study description for COSMEX

 Exacerbations/year = 5.02 pre-treatment vs 0.98 >136 weeks. 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. Results are descriptive. Statistical significance was not achieved.

Nucala: Proven reduction in exacerbations³

Clinical trial data: Exacerbation reduction in the MENSA trial3
Please see full study description for MENSA

MENSA (32 weeks) 53% reduction in exacerbations vs. placebo: NUCALA 0.83/year (n=194) vs. placebo 1.74/year (n=191) (95% CI: 36–65) p<0.001. This was the primary endpoint.

Nucala: Proven reduction in asthma exacerbations in patients with co-morbid nasal polyps⁷

MENSA (32 weeks)/MUSCA (24 weeks) post hoc meta-analysis⁷
Nucala is not indicated for nasal polyps.
 
musca-chart

Nucala is not licensed for the treatment of nasal polyps.
This was a post hoc meta-analysis of MENSA and MUSCA 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: Demonstrated a reduction in maintenance OCS in the real world 

setting¹ ²

Real-world data: Reduction in maintenance OCS dose in REALITI-A study (vs. baseline)²
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.
Results are descriptive. Statistical significance was not achieved.

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

Adapted from Taillé C et al. Eur Respir J 2020

Please see full study description for FRANCE ATU

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. 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

Nucala: long-term reduction in OCS use⁶

Long-term data: OCS reduction in the COSMEX study6

Nucala: Proven reduction in OCS dose⁴

Clinical trials: Median daily OCS dose reduction in SIRIUS study⁴

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).

Please see full study description for SIRIUS
SIRIUS secondary endpoint: Median daily OCS dose reduction

Footnotes

*An exacerbation is defined as deterioration in asthma requiring use of systemic corticosteroids and/or an ED visit and/or hospital admission.

**The maximum exposure duration of mepolizumab in the phase 3 and open label extension studies was 4.8 years. A patient withdrawal range of 4 weeks to 4.8 years was observed in MENSA, SIRIUS, COSMOS and COSMEX.

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.⁸

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; 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)
  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, 2020
  6. Khurana S et al. Clin Ther 2019; 41:2041–2056
  7. Laidlaw T et al. Am J Respir Crit Care Med 2019; 199: A2672
  8. Leather DA, et al. Adv Ther. 2020;1-21

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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PM-GB-MPL-WCNT-200025 | November 2020