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
Long-term data: Exacerbation reduction in the COSMEX study (n=340)6
Nucala: Proven reduction in exacerbations3
Clinical trial data: Exacerbation reduction in the MENSA trial3
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
Patients free from maintenance OCS
Real-world evidence: OCS dose reduction in the France ATU study
Nucala: Proven reduction in OCS dose4
Clinical trials: SIRIUS trial OCS reduction (n=135)4
*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.
- 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.
© 2023 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 | February 2023