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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).4
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.
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 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
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 polyps7
MENSA (32 weeks)/MUSCA (24 weeks) post hoc meta-analysis7
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.
**REALITI-A is a 2-year international, prospective, single-arm, observational study. Data from the 12-month interim analysis of the full population.9 The primary endpoint is the rate of clinically significant exacerbations defined as exacerbations requiring OCS and/or ED visits/hospitalisation (p<0.001).9
ED, emergency department; mg, milligram; OCS, oral corticosteroids.
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
+REALITI-A is a 2-year international, prospective, single-arm, observational study. Primary endpoint: rate of clinically significant exacerbations defined as exacerbations requiring OCS and/or hospitalisation/ED visit: 1.11/year at 2 years vs. 4.25/year at baseline (RR: 0.26 [95% CI: 0.24, 0.29]; p<0.001).2, 10
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).
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
- Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/1399 3003.02345-2019) [Epub ahead of print]
- Caruso C, Canonica GW, Patel M, et al. International, prospective study of mepolizumab in severe asthmas: REALITI-A at 2yrs. A bstract presented at ERS; 4-6 September 2022; Barcelona, Spain.
- 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, Available from: www.medicines.ie Last accessed: February 2023
- Khurana S et al. Clin Ther 2019; 41:2041–2056
- Chupp GL et al. Lancet Respir Med 2017; 5:390–400
- Leather DA, et al. Adv Ther. 2020;1–21
- Liu MC, Bagnasco D, Matucci A,et al. The Impact of Comorbid Nasal Polyps on Real-World Mepolizumab Effectiveness in Patients with Severe Asthma: Results from the REALITI-A Study. Poster No. 609 presented at the American Thoracic Society Meeting; 2022 May 13-18 San Francisco, CA.
- Pilette C, Canonica GW, Chaudhuri R, et al. International, Prospective Real-World Study of Mepolizumab in Patients with Severe Asthma at One Year: REALITI-A. Poster presented at the European Respiratory Society (ERS) Congress; 2021.
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
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PM-IE-MPL-WCNT-200014 | February 2023
