Nucala reduced the rate of exacerbations* by 53% compared with placebo at 32 weeks in MENSA randomised control trial (Primary endpoint: 0.83 Nucala (n=194) vs. 1.74 placebo (n=191) (95% CI: 36–65) p<0.001).⁷
Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older.³
*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.¹⁰ France ATU (cohort of patients in France) was a retrospective observational study.¹
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.³
The long-term safety and immunogenicity profile of Nucala was similar to that observed in placebo-controlled asthma trials.⁹
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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Trade marks are owned by or licensed to the GSK group of companies.
PM-GB-MPL-WCNT-200040 | December 2020