NCT06148493

Real-World Usage of Asciminib Among Patients With Chronic Myeloid Leukemia in Chronic Phase in the United States Using a Large Claims Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 425 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a retrospective descriptive analysis of health care claims data using the IQVIA open source medical and pharmacy claims databases. Patients were grouped into one of two cohorts depending on the index medication. All patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 30 April 2022 in (Phase 1) were grouped into the asciminib cohort. A data refresh was conducted (Phase 1 refresh) and all patients with at least 1 pharmacy claim for asciminib occurring between 01 January 2021 and 29 August 2022 were included in the asciminib cohort. Patients were required to have at least 6 months of continuous data availability prior to the start of treatment and were followed from the start of treatment until the end of available follow-up. The end of available follow up in open source data was defined as 1) last claim date in medical or pharmacy data, OR 2) last day of index pharmacy stability, OR 3) end of study period, whichever came first. While no post-index data availability were required in Phase 1, a subgroup analysis was conducted in patients with at least 3 and 6 months of available follow-up after the index date in Phase 1 refresh. In Phase 2 of the study, patients with no exposure to asciminib and with at least 1 pharmacy claim for imatinib mesylate, dasatinib, nilotinib, bosutinib or ponatinib were indexed to the first new tyrosine kinase inhibitor (TKI) observed between 01 January 2021 and 29 August 2022 and grouped into the other TKI cohort. The index date was the initiation date of the index medication. Patients were required to have linkage to the open-source medical claims database and at least 3 months of available follow-up after the index date.

Conditions

• Chronic Myeloid Leukemia

Timeline

• Start date: 2022-09-20
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2023-11-28
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States