Nagase Hiroyuki, Kobayashi Konomi, Toma-Hirano Makiko, Suzukawa Maho, Harada Norihiro, Masaki Katsunori, Miyata Yoshito, Tsuji Mayoko, Terada-Hirashima Junko, Komatsuzaki Keiko, Sasano Hitoshi, Mizumura Kenji, Kagoya Ryoji, Shimizu Yuya, Yoshihara Shintaro, Kihara Norio, Miyazaki Yasunari, Koya Toshiyuki, Sugihara Naruhiko, Ishikawa Nobuhisa, Hojo Masayuki, Tagaya Etsuko, Tanaka Akihiko, Fukunaga Koichi, Gon Yasuhiro
Division of Respiratory Medicine and Allergology, Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan; Teikyo Allergy Center, Teikyo University Hospital, Tokyo, Japan.
Division of Respiratory Medicine and Allergology, Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan; Teikyo Allergy Center, Teikyo University Hospital, Tokyo, Japan.
Allergol Int. 2025 Jul;74(3):435-444. doi: 10.1016/j.alit.2024.12.005. Epub 2025 Jan 22.
Although randomized controlled trials (RCT) have demonstrated the efficacy of mepolizumab for asthma, they have excluded certain patient subgroups. To bridge the gap between RCT and real-world practice, the effectiveness of mepolizumab in a diverse population, including those potentially excluded from RCT, was assessed. Its effects on imaging findings and symptoms of chronic rhinosinusitis (CRS) with asthma were also assessed.
This retrospective observational study of patients in Japan (J-Real-Mepo: UMIN000045021) evaluated multiple endpoints and analyzed the relationship between clinical background and treatment outcomes.
Mepolizumab significantly reduced exacerbations, improved Asthma Control Test (ACT) scores, and forced expiratory volume in 1 s, and reduced oral corticosteroid (OCS) dose, regardless of patient characteristics, including age, body mass index, smoking history, and comorbidities. Regarding RCT exclusion criteria, 29.4 % of patients had no history of exacerbations. Although 25.4 % of these patients required continuous OCS, the OCS dose was reduced similar to those with a history of exacerbations. Disease control and mepolizumab effectiveness in patients with a smoking history ≥10 pack-years was similar to that of never-smokers. Patients with eosinophil counts <150/μL had lower ACT scores and higher OCS use compared with patients with eosinophilia and comparable effectiveness regarding exacerbation and OCS reduction. Significant improvements in Lund-Mackay scores and CRS symptoms were observed.
Mepolizumab effectiveness was demonstrated in a broad range of patients including those with RCT exclusion criteria, who had significant disease or OCS burden. These findings may explain the consistent results between RCT and real-world studies of mepolizumab.
尽管随机对照试验（RCT）已证明美泊利珠单抗对哮喘有效，但这些试验排除了某些患者亚组。为弥合RCT与实际临床实践之间的差距，评估了美泊利珠单抗在包括可能被RCT排除的人群在内的多样化人群中的有效性。还评估了其对合并哮喘的慢性鼻-鼻窦炎（CRS）影像学表现和症状的影响。
这项针对日本患者的回顾性观察研究（J-Real-Mepo：UMIN000045021）评估了多个终点，并分析了临床背景与治疗结果之间的关系。
无论患者特征如何，包括年龄、体重指数、吸烟史和合并症，美泊利珠单抗均能显著减少哮喘发作、提高哮喘控制测试（ACT）分数和第1秒用力呼气量，并减少口服糖皮质激素（OCS）剂量。关于RCT排除标准，29.4%的患者无哮喘发作史。尽管这些患者中有25.4%需要持续使用OCS，但其OCS剂量的减少情况与有哮喘发作史的患者相似。吸烟史≥10包年的患者的疾病控制情况和美泊利珠单抗有效性与从不吸烟者相似。与嗜酸性粒细胞增多的患者相比，嗜酸性粒细胞计数<150/μL的患者ACT分数较低、OCS使用量较高，且在哮喘发作和OCS减量方面有效性相当。观察到Lund-Mackay评分和CRS症状有显著改善。
在包括具有RCT排除标准、有显著疾病或OCS负担的广泛患者中，均证明了美泊利珠单抗的有效性。这些发现可能解释了RCT与美泊利珠单抗真实世界研究结果一致的原因。
