Treatment with mepolizumab was associated with a significant reduction in asthma exacerbations and oral corticosteroid use in patients with severe eosinophilic asthma, according to findings from an interim analysis of the REALITI-A study.
REALITI-A is a 2-year, prospective, single-arm, observational study evaluating the safety and efficacy of mepolizumab, an interleukin-5 antagonist, in patients with severe eosinophilic asthma (N=368) in a routine care setting. The primary end point of the study is the rate of clinically significant exacerbations, defined as exacerbations requiring oral corticosteroid use and/or emergency room visit/hospitalization.
Results from the interim analysis showed that 1 year of treatment with mepolizumab was associated with a 69% reduction in the annual rate of clinically significant exacerbations (risk ratio [RR] 0.31, 95% CI: 0.27, 0.35) and a 77% reduction in the annual rate of exacerbations requiring hospitalization/emergency room visit (RR 0.23, 95% CI: 0.18, 0.30). In addition, the findings showed that 34% of mepolizumab-treated patients were able to discontinue oral corticosteroid use.
The safety profile of mepolizumab was found to be consistent with those previously observed in other trials. The most common treatment-emergent adverse events included headache, nausea, fatigue, influenza-like illness, back pain, and myalgia.
“The interim results from REALITI-A continue to demonstrate [mepolizumab] effectively reduces exacerbations, this time in a routine care setting,” said Christopher Corsico, Senior Vice President Development, GSK. “We look forward to sharing the full results from this study after it completes in 2021.”
Mepolizumab (Nucala) is currently approved for use as an add-on maintenance treatment for patients with severe asthma with an eosinophilic phenotype. It is also indicated in the treatment of eosinophilic granulomatosis with polyangiitis.
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