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].

中文翻译：

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加用美泊利单抗治疗严重嗜酸性粒细胞性哮喘的青少年的疗效

患有严重嗜酸性粒细胞性哮喘的青少年（12-17岁）经常加重病情，肺功能下降，导致与健康相关的生活质量较差。根据II / III期临床试验表明，Mepolizumab被批准用于欧盟范围内≥6岁且其他地区（包括美国）≥12岁的重度嗜酸性哮喘患者的补充维持治疗。每周治疗4次。III期美泊珠单抗试验共招募了34名青春期患者。与总体人群的预后一致，青少年患者每年因美泊利单抗而产生的临床上显着加重的年率降低，且嗜酸性粒细胞计数降低。青少年患者的安全性与总体人群中的安全性一致。来自III期临床开发计划的数据提供了美泊利珠单抗在严重嗜酸性粒细胞性哮喘青少年与总体人群之间具有可比的疗效和安全性的证据。临床试验注册DREAM，NCT01000506 [MEA112997]；MENSA，NCT01691521 [MEA115588]；SIRIUS，NCT01691508 [MEA115575]；MUSCA，NCT02281318 [200862]；COSMOS，NCT01842607 [MEA115661]。