Nucala: Powerful and lasting reduction in exacerbations and OCS dose, supported by real life studies¹⁻⁴,⁶
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. 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.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; IL, interleukin; IV, intravenous; OCS, oral corticosteroid; RCT, randomised controlled trial; SC, subcutaneous; SEA, Severe eosinophilic asthma.
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PM-BE-MPL-WCNT-200042 - August 2020