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.”

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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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