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
*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.
Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
© 2021 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 | March 2021