Myeloid Leukemia, Chronic
Conditions
Keywords
Tyrosine Kinase Inhibitor, Real-world
Brief summary
The main goal of this study was to describe treatment patterns of patients with chronic myeloid leukemia (CML) who were treated with tyrosine kinase inhibitors (TKIs) in Japan. This was a retrospective observational study with secondary use of data from the Medical Data Vision (MDV) hospital-based database. The index date was the date of the first prescription of any TKI of interest registered within the selection period (01 January 2011 to 31 December 2019). The follow-up period was from the index date until the end of the study period, end of continuous follow-up in the MDV database, or death, whichever came first.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who met all the below inclusion criteria and none of the
Exclusion criteria
were included in the study. Inclusion criteria: * Patients who had at least one TKI prescription during the selection period, * a confirmed diagnosis of chronic phase CML recorded before or at the index date, * were aged 15 years or older at the index date, and * had at least 12-months continuous pre-index period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of TKI Treatment by LoT | Up to approximately 9 years | — |
| Number of Patients who Discontinued TKI Treatment by Type of TKI | Up to approximately 9 years | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. |
| Number of Patients who Discontinued TKI Treatment for at Least One Year by Type of TKI | Up to approximately 9 years | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. |
| Number of Patients who Restarted any TKI Treatment After Discontinuing the TKI of Interest by Type of TKI | Up to approximately 9 years | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. |
| TKI Dose by LoT | Baseline, up to approximately 9 years | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. |
| TKI Persistence Rate by LoT | Months 6, 12, 18, and Year 5 | — |
| Number of Patients by Line of Treatment (LoT) and TKI Received | Up to approximately 9 years | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. |
| Number of Patients who Switched TKI Treatment by LoT and TKI | Up to approximately 9 years | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual Mean Cost of All-cause Healthcare Resource Use by LoT | Up to approximately 9 years | All-cause care included inpatient and outpatient visits. The following costs were calculated in Japanese yen (JPN): * Total costs * Inpatient costs * Outpatient costs * Pharmacy costs |
| Annual Incidence of CML-related Healthcare Resource Use by LoT | Up to approximately 9 years | CML-related care included: * Major BCR-ABL1 procedures (diagnostic and response to treatment testing) * Complete blood count testing - peripheral blood general testing * Hematological examination diagnosis fee * TKI prescriptions |
| Annual Mean Cost of CML-related Healthcare Resource Use by LoT | Up to approximately 9 years | CML-related care costs were calculated in Japanese Yen (JPY) and included the following: * Total CML-related costs * Major BCR-ABL1 procedure costs * Complete blood count testing - peripheral blood general testing costs * Hematological examination costs * TKI prescription costs |
| Number of Patients With Adverse Events by TKI | Up to approximately 9 years | TKIs included imatinib, bosutinib, dasatinib, nilotinib, and ponatinib. |
| Annual Incidence of Inpatient and Outpatient Visits by LoT | Up to approximately 9 years | — |
Countries
United States
Outcome results
None listed