Clinical characteristics of patients with not well-controlled severe asthma in Japan: Analysis of the Keio Severe Asthma Research Program in Japanese population (KEIO-SARP) registry

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  • Tanosaki Takae
    Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
  • Kabata Hiroki
    Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
  • Matsusaka Masako
    Department of Laboratory of Bioregulatory Medicine, Kitasato University School of Pharmacy
  • Miyata Jun
    Division of Infectious Diseases and Respiratory Medicine, Department of Internal Medicine, National Defense Medical College
  • Masaki Katsunori
    Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
  • Mochimaru Takao
    Respiratory Medicine, National Hospital Organization Tokyo Medical Center
  • Okuzumi Shinichi
    Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
  • Kuwae Misato
    Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
  • Watanabe Risa
    Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine
  • Suzuki Yusuke
    Respiratory Medicine, Kitasato University Kitasato Institute Hospital
  • Sayama Koichi
    Respiratory Medicine, Kawasaki Municipal Hospital
  • Izuhara Kenji
    Division of Medical Biochemistry, Department of Biomolecular Sciences, Saga Medical School
  • Asano Koichiro
    Division of Pulmonary Medicine, Department of Medicine, Tokai University School of Medicine
  • Fukunaga Koichi
    Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine

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<p>Background: Multiple phenotypes exist within the classification of severe asthma. However, characteristics of patients with not well-controlled severe asthma have not been well identified.</p><p>Methods: Japanese patients with asthma (age ≥ 20 years) were enrolled at the Keio University Hospital and its affiliated hospitals in this observational study (Keio Severe Asthma Research Program). Among them, patients with severe asthma (those undergoing Global Initiative for Asthma [GINA] 2018 step 4 or 5 treatment) were included in this analysis and investigated clinical characteristics based on asthma control status.</p><p>Results: Of the 154 patients (men, 46.8%; age, 60.1 ± 14.9 years), 87 (56.5%) had not well-controlled (partly controlled and uncontrolled) asthma (GINA step 4, 42 patients; step 5, 45 patients). Overall, there were no significant differences in clinical characteristics between patients with well-controlled and not well-controlled asthma. However, cluster analysis revealed that distinct 5 clusters (cluster 1, well-controlled; cluster 2, eosinophilic; cluster 3, non–type 2 inflammation; cluster 4, high periostin; and cluster 5, late-onset type 2 inflammation), and clusters 2–5 were not well-controlled. Among them, cluster 3 was characterized by low eosinophil counts, low periostin levels, and less frequent olfactory disturbance, and this cluster had the worst asthma control.</p><p>Conclusions: Japanese patients with severe asthma were divided into well-controlled and not-well controlled asthma, and we confirmed heterogeneity of not well-controlled severe asthma. These patients, especially non-type 2 phenotype, require a further therapeutic approach. (University Hospital Medical Information Network Clinical Trials Registry, UMIN000002980)</p>

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