Nucala demonstrated a reduction in exacerbations and maintenance OCS in the real world setting¹ ²
MENSA (32 week randomised control trial) 53% reduction in exacerbations* vs. placebo: NUCALA 0.83/year (n=194) vs. placebo 1.74/year (n=191) (95% CI: 36–65) p<0.001. This was the primary endpoint.³
SIRIUS randomised control trial secondary endpoint: Median daily OCS dose reduction. 50% NUCALA (n=69) (95% CI: 20.0–75.0) vs. 0% placebo (n=66) (95% CI: -20.0–33.3) (p=0.007).⁴ The primary endpoint, the percentage reduction in maintenance OCS dose while maintaining asthma control, was met.⁴
*An exacerbation is defined as deterioration in asthma requiring use of systemic corticosteroids and/or an ED visit and/or hospital admission.
**The maximum exposure duration of mepolizumab in the phase 3 and open label extension studies was 4.8 years. A patient withdrawal range of 4 weeks to 4.8 years was observed in MENSA, SIRIUS, COSMOS and COSMEX.
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.⁸
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; OCS, oral corticosteroid; RCT, randomised controlled trial; SC, subcutaneous; SEA, Severe eosinophilic asthma.
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
© 2020 GSK group of companies or its licensor.
Trade marks are owned by or licensed to the GSK group of companies.
PM-GB-MPL-WCNT-200025 | November 2020