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).⁷
*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.⁹
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 | March 2021