Real-world use of BTK inhibitors for chronic lymphocytic leukemia in Japan: A retrospective observational database study

• Published in: Journal of Clinical and Experimental Hematopathology Vol. 65; no. 1; pp. 17 - 27
• Main Authors: Nishikori, Momoko, Nozaki, Kenji, Hayashi, Yuko, Arita, Yoshifumi, Fujiwara, Masakazu, Iwao, Chikako, Kitagawa, Hiroshi, Maruyama, Dai
• Format: Journal Article
• Language: English
• Published: Japan Japanese Society of Lymphoma Research 28.03.2025; The Japanese Society of Lymphoma Research; 一般社団法人 日本リンパ腫学会; JSLRT
• Subjects: Adult; Agammaglobulinaemia Tyrosine Kinase - antagonists & inhibitors; Aged; Aged, 80 and over; Bruton tyrosine kinase inhibitors; chronic lymphocytic leukemia; database study; Databases, Factual; Female; Humans; Japan; Japan - epidemiology; Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy; Leukemia, Lymphocytic, Chronic, B-Cell - enzymology; Leukemia, Lymphocytic, Chronic, B-Cell - epidemiology; Male; Middle Aged; Original; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - therapeutic use; Retrospective Studies; Japan; database study; chronic lymphocytic leukemia; Japan; Bruton tyrosine kinase inhibitors
• ISSN: 1346-4280; 1880-9952
• DOI: 10.3960/jslrt.24049

Little is known about real-world treatment practices for chronic lymphocytic leukemia (CLL) in Japan. We aimed to assess the time to discontinuation/dose reduction of Bruton tyrosine kinase inhibitors (BTKis) in patients with CLL in a real-world clinical setting in Japan. This was a retrospective observational database study using data from the Medical Data Vision database (from 1 May 2016 to 30 September 2021). Among the 483 patients with CLL who were treated with BTKis, 182 (37.7%) started treatment with a reduced dose of BTKi (lower than the standard dose), 302 (62.5%) experienced at least one dose reduction during the study period, and 123 (25.5%) discontinued BTKi treatment early (for any reason) during the study period. The median time to BTKi discontinuation was 52.3 weeks in 286 patients who started treatment with a standard dose and 57.1 weeks in 182 patients who started treatment with a reduced dose. The use of prophylaxis with anti-infectives was similar during treatment with BTKis and non-BTKis. There was no major difference in the incidence rate of cardiovascular-related adverse events during treatment with BTKis and non-BTKis. This study provides valuable information for future research on the treatment of CLL patients in Japan.