A Retrospective Cohort Study of Clinical Features and Treatment Patterns With Ustekinumab in Patients With Crohn Disease Utilizing a Health Care Database in Japan.
Journal
The Annals of pharmacotherapy
Journal Volume
57
Journal Issue
9
Start Page
1053
End Page
1061
ISSN
1542-6270
Date Issued
2023-09
Author(s)
Liu, Yanfang
Goh, Choo Hua
Qiu, Hong
Huang, Kuan-Chih
Chung, Hsingwen
Saadoun, Carine
Abstract
Biologics are used to treat moderate-to-severe Crohn disease (CD). In Japan, ustekinumab was approved for reimbursement for CD treatment in 2017. However, limited information describes utilization of ustekinumab in real-world settings.
To describe treatment patterns and clinical outcomes of patients with CD treated with ustekinumab in Japan.
A retrospective cohort drug utilization study was conducted using the Japan Medical Data Center employment insurance database. Patients with a diagnosis of CD who initiated treatment with ustekinumab ( [] K50.x) from January 1, 2017, to September 30, 2020, were enrolled. Eligible patients were followed up until disenrollment or study end (September 30, 2020).
A total of 622 patients with CD initiated ustekinumab during the study period; 45.7% had no prior history of biologic use (bio-naive) and 54.3% had previously received ≥1 biologic (bio-experienced); 82.8% of patients received an induction dose of whom 97.5% received a dose within the recommended range (260-520 mg) and 90.8% of patients received their first maintenance dose within a 42- to 70-day interval. Median treatment duration was 14.8 months and 90.2% remained on ustekinumab at study end. Compared with the 12-month period prior to ustekinumab initiation, surgical procedures decreased by 88.0%, gastrointestinal complications by 64.6%, enteral nutrition requirements by 41.9%, and CD-related hospitalizations by 62.6% within 12 months after commencing ustekinumab.
These first real-world data from Japan, where ustekinumab has been used longest for CD treatment, shows that a majority of patients initiated ustekinumab as per the recommended label. Indirect evidence of clinical impact could be relevant in other settings in Asia.
Subjects
Crohn disease
Japan
complication
surgery
ustekinumab
Type
journal article