Korean J Intern Med.
2021 Mar;36(2):362-370. 10.3904/kjim.2019.198.
Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies
- Affiliations
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- 1Division of Allergy and Clinical Immunology, Department of Internal Medicine, Chungbuk National University College of Medicine, Cheongju, Korea
- 2Department of Allergy and Clinical Immunology, Ajou University School of Medicine, Suwon, Korea
- 3Department of Pulmonology and Allergy, Soonchunhyang University Bucheon Hospital, Bucheon, Korea
- 4Respiratory Medical, GSK Korea, Seoul, Korea
- 5Global Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA
- 6Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA
- 7Clinical Statistics, GSK, Uxbridge, UK
- 8Respiratory Medical Franchise, GSK, Brentford, UK
- KMID: 2513747
- DOI: http://doi.org/10.3904/kjim.2019.198
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.
