Nucala reduced the rate of exacerbations* by 53% compared with placebo at 32 weeks in the MENSA study (Primary endpoint: 0.83 Nucala (n=194) vs. 1.74 placebo (n=191) (95% CI: 36–65) p<0.001).6
This is real life
Real-world studies now prove the efficacy (exacerbation and OCS reduction compared to baseline) of Nucala in everyday practice.1
Nucala provides real-life protection from exacerbations and maintenance OCS vs. baseline whilst reducing eosinophils to normal levels1, 3-5
Nucala reduced median daily OCS dose by 50% at 24 weeks in the SIRIUS study (Secondary endpoint: 50% Nucala (n=69) (95% CI: 20.0–75.0) vs. 0% placebo (n=66) (95% CI: -20.0–33.3) p=0.007).7
What role do eosinophils play in health and disease?
NUCALA PRE-FILLED PEN2
Nucala is the only once-monthly asthma biologic with a simple fixed dose.2
*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.²¹ France ATU (cohort of patients in France) was a retrospective observational study.1
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.
The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.8
- Taillé C et al. Eur Respir J 2020; in press (https://doi.org/10.1183/13993003.02345-2019) Last accessed: December 2022
- Nucala SmPC, from www.medicines.ie Last Accessed: December 2022
- Lugogo N et al. Clinical Therapeutics 2016; 38;2058–2070
- Yancey SW et al. J Allergy Clin Immunol 2017; 140:1509–1518
- Hartl S et al. Eur Respir J 2020; 1–34
- Ortega HG et al. N Engl J Med 2014; 371:1198–1207
- Bel EH et al. N Engl J Med 2014; 371:1189–1197
- Khurana S et al. Clin Ther 2019; 41:2041–2056
- Heredia JE, et al. Cell 2013;153;376–388
- Wu D, et al. Science 2011;332;243–7
- Zhu L, et al. PloS one 2013;8;e67613;1–6
- Yang J, Torio A, Donoff RB, et al. Depletion of eosinophil infiltration by anti-IL-5 monoclonal antibody (TRFK-5) accelerates open skin wound epithelial closure. Am J Pathol. 1997;151(3):813-819.
- Ramirez GA, et al. Biomed Res Int 2018:9095275
- Wenzel SE, et al. Am J Respir Crit Care Med 1999;160:1001–1008
- de Carvalho-Pinto RM, et al. Resp Med 2012;106:47–56
- Haldar P, et al. Am J Respir Crit Care Med 2008;178:218–224
- Albers FC, et al. J Asthma 2018;55:152–160
- Weller F & Spencer LA Nat Rev Immunol 2017;17:746–760
- Wen T & Rothenberg E. Microb Spectr 2016;4:doi:10.1128/microbiolspec.MCHD-0020-2015
- Leather DA et al. Adv Ther 2020; 1–21
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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Trade marks are owned by or licensed to the GSK group of companies.
PM-IE-MPL-WCNT-200012 | January 2023