Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma

Steven W Yancey, Hector G Ortega, Oliver N Keene, Eric S Bradford, Steven W Yancey, Hector G Ortega, Oliver N Keene, Eric S Bradford

Abstract

Adolescents (12-17 years of age) with severe eosinophilic asthma experience frequent exacerbations and reduced lung function leading to poor health-related quality of life. Mepolizumab is approved for add-on maintenance therapy in patients with severe eosinophilic asthma ≥ 6 years of age in the EU and ≥ 12 years of age in other regions (including the USA), based on a Phase II/III program demonstrating reduced exacerbation rates with 4-weekly treatment. A total of 34 adolescent patients were recruited across the Phase III mepolizumab trials. Consistent with outcomes in the overall population, there was a reduction in the annual rate of clinically significant exacerbations, along with a reduction in blood eosinophil counts in response to mepolizumab in adolescent patients. The safety profile in adolescent patients was consistent with that seen in the overall population. Data from the Phase III clinical development program provide evidence for comparable efficacy and safety of mepolizumab between adolescents with severe eosinophilic asthma and the overall population. Clinical trial registration DREAM, NCT01000506 [MEA112997]; MENSA, NCT01691521 [MEA115588]; SIRIUS, NCT01691508 [MEA115575]; MUSCA, NCT02281318 [200862]; COSMOS, NCT01842607 [MEA115661].

Keywords: Adolescent; Asthma control; Eosinophils; Exacerbations; Mepolizumab; Severe eosinophilic asthma.

Conflict of interest statement

Competing interestsSWY, ONK, and ESB are GSK employees and hold GSK stocks/shares. HGO was an employee of GSK during the time of the analysis and is now employed by Gossamer Bio.

Figures

Fig. 1
Fig. 1
Clinically significant exacerbation rate/year in adolescent and adult patients in the MENSA and MUSCA trials. Analyses were conducted using a negative binomial regression model including covariates for use of maintenance oral corticosteroids, geographic region, number of exacerbations in the previous year, baseline percentage of the predicted FEV1 (MENSA and MUSCA) and treatment (MENSA only). Increases in 95% CIs observed in adolescent groups are a result of the smaller sample size when compared with ≥ 18 years; CI: confidence interval; FEV1: forced expiratory volume in 1 s

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