1. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies
- Author
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Bhabita Mayer, Choon-Sik Park, Mi-Kyeong Kim, Nam-Hee Kwon, Hae-Sim Park, Soung-Jun Min, Frank C. Albers, and Steven W. Yancey
- Subjects
medicine.medical_specialty ,Pulmonology ,Population ,Antibodies, Monoclonal, Humanized ,Placebo ,03 medical and health sciences ,0302 clinical medicine ,republic of korea ,Internal medicine ,Post-hoc analysis ,therapeutics ,medicine ,Humans ,Anti-Asthmatic Agents ,Child ,education ,Adverse effect ,Asthma ,education.field_of_study ,business.industry ,asthma ,medicine.disease ,symptom flare up ,Clinical trial ,Asthma Control Questionnaire ,Medicine ,Original Article ,030211 gastroenterology & hepatology ,business ,Mepolizumab ,medicine.drug - Abstract
Background/aims The efficacy and safety of mepolizumab in patients with severe eosinophilic asthma has been evaluated in a global clinical trial programme. This post hoc analysis assesses the efficacy and safety of mepolizumab in Korean patients. Methods Data from Korean patients in the Phase III, placebo-controlled, randomised DREAM (MEA112997/NCT01000506) and MENSA (MEA115588/ NCT01691521) studies were included. Patients ≥ 12 years old with severe eosinophilic asthma received mepolizumab (DREAM: 75, 250 or 750 mg intravenously [IV]; MENSA: 75 mg IV or 100 mg subcutaneously [SC]), or placebo every 4 weeks for 52 weeks (DREAM) or 32 weeks (MENSA). The primary outcome was the rate of clinically significant asthma exacerbations. Secondary outcomes included forced expiratory volume in 1 second (FEV1), Asthma Control Questionnaire (ACQ) and St George's Respiratory Questionnaire (SGRQ) scores (MENSA only). Blood eosinophil counts (BEC) and safety were assessed throughout. Results Reductions in the rate of clinically significant asthma exacerbations were observed with the approved (100 mg SC) and bioequivalent (75 mg IV) doses of mepolizumab in Korean patients who participated in DREAM and MENSA. In MENSA, trends for improvements from baseline at week 32 in pre-bronchodilator FEV1 (75 mg IV group), ACQ-5 and SGRQ scores (in both treatment groups) were seen versus placebo in Korean patients. Incidence of on-treatment adverse events was similar in Korean patients versus non-Korean patients as were observed reductions from baseline in BEC. Conclusions Mepolizumab treatment provided clinical benefits for Korean patients with severe eosinophilic asthma; the safety profile is consistent with the overall population.
- Published
- 2021
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