Department of Allergy and Respiratory Medicine, Sutoh Hospital, Annaka, Gunma, Japan.
J Investig Allergol Clin Immunol. 2019;29(1):40-45. doi: 10.18176/jiaci.0285. Epub 2018 Jun 29.
The long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma has been evaluated in large-scale double-blind placebo-controlled trials. However, a prospective open-label trial of long-term subcutaneous administration of mepolizumab has not been performed in Japanese patients with severe eosinophilic asthma.
This study was a prospective, 48-week, open-label trial in 32 Japanese patients with severe eosinophilic asthma who received subcutaneous mepolizumab 100 mg every 4 weeks. Nine patients required oral corticosteroids daily despite receiving high-dose inhaled corticosteroids. Six patients had aspirin-exacerbated respiratory disease.
All patients took mepolizumab throughout the study period. No patients experienced adverse events during the treatment. None of the patients experienced asthma exacerbations during the trial. In fact, forced expiratory volume in 1 second increased significantly at 24 weeks (P<.01) and at 48 weeks (P<.05). The peripheral blood eosinophil count in peripheral blood decreased after the first administration of mepolizumab in all patients and remained low until week 48. After starting mepolizumab, all oral corticosteroid-dependent asthmatics successfully withdrew corticosteroids without exacerbations and experienced a sustained reduction in peripheral blood eosinophil count. Blood levels of thymus and activation-regulated chemokine and IgE remained unchanged after 48 weeks of therapy with mepolizumab.
This first prospective open-label pilot study in Japan demonstrated the long-term efficacy and safety of mepolizumab in patients with severe eosinophilic asthma.
美泊利珠单抗在重度嗜酸性粒细胞性哮喘患者中的长期疗效和安全性已在大规模双盲安慰剂对照试验中得到评估。然而，尚未在日本重度嗜酸性粒细胞性哮喘患者中进行美泊利珠单抗皮下长期给药的前瞻性开放标签试验。
这是一项针对 32 名日本重度嗜酸性粒细胞性哮喘患者的前瞻性、48 周、开放标签试验，这些患者每 4 周接受 100mg 皮下美泊利珠单抗治疗。9 名患者尽管接受了高剂量吸入性皮质类固醇治疗，但仍需每日口服皮质类固醇。6 名患者患有阿司匹林加重性呼吸系统疾病。
所有患者在整个研究期间均接受了美泊利珠单抗治疗。在治疗期间，没有患者发生不良事件。在试验期间，没有患者发生哮喘恶化。事实上，用力呼气量在 24 周时（P<.01）和 48 周时（P<.05）显著增加。所有患者在接受美泊利珠单抗首次给药后外周血嗜酸性粒细胞计数均下降，直至第 48 周仍保持低值。开始使用美泊利珠单抗后，所有依赖口服皮质类固醇的哮喘患者成功停用皮质类固醇，无恶化发生，并持续降低外周血嗜酸性粒细胞计数。在接受美泊利珠单抗治疗 48 周后，胸腺和活化调节趋化因子和 IgE 的血液水平保持不变。
这项在日本进行的首个前瞻性开放标签初步研究表明，美泊利珠单抗治疗重度嗜酸性粒细胞性哮喘患者具有长期疗效和安全性。
