Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma.
Steven W YanceyHector G OrtegaOliver N KeeneEric S BradfordPublished in: Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology (2019)
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].
Keyphrases
- chronic obstructive pulmonary disease
- lung function
- clinical trial
- young adults
- phase iii
- phase ii
- open label
- end stage renal disease
- newly diagnosed
- ejection fraction
- prognostic factors
- mental health
- physical activity
- metabolic syndrome
- quality improvement
- intensive care unit
- type diabetes
- bone marrow
- big data
- peripheral blood
- glycemic control
- deep learning
- chemotherapy induced