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Updated: Jun 27, 2026
Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 19, 2013
Real-world use of BTK inhibitors for chronic lymphocytic leukemia in Japan: A retrospective observational database
Momoko Nishikori1,2, Kenji Nozaki3, Yuko Hayashi3
1Department of Hematology, Kyoto University Hospital, Kyoto, Japan.
Insights
Real-world data in Japan shows that many chronic lymphocytic leukemia (CLL) patients require dose adjustments or discontinuation of Bruton tyrosine kinase inhibitors (BTKis). Median discontinuation time was over a year for both standard and reduced initial doses.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Chronic lymphocytic leukemia (CLL) treatment practices in Japan are not well-documented.
- Bruton tyrosine kinase inhibitors (BTKis) are a key therapy for CLL, but real-world usage patterns require investigation.
Purpose of the Study:
- To evaluate the real-world utilization of BTKis in Japanese CLL patients.
- To assess the time to dose reduction or discontinuation of BTKis in this population.
Main Methods:
- Retrospective observational database study using the Medical Data Vision database (May 2016 - September 2021).
- Analysis of 483 CLL patients treated with BTKis, focusing on initial dosing, dose reductions, and treatment discontinuation.
Main Results:
- 37.7% of patients initiated BTKis at a reduced dose; 62.5% experienced dose reduction during treatment.
- Median time to BTKi discontinuation was 52.3 weeks for standard initial dose and 57.1 weeks for reduced initial dose.
- Anti-infective prophylaxis and cardiovascular adverse event rates were similar between BTKi and non-BTKi treatments.
Conclusions:
- Real-world BTKi use in Japan involves frequent dose modifications and early discontinuation.
- Findings offer insights into BTKi management and inform future research for CLL patients in Japan.
Abstract:
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.
