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A Retrospective Cohort Study of Clinical Features and Treatment Patterns With Ustekinumab in Patients With Crohn Disease Utilizing a Health Care Database in Japan

A Retrospective Cohort Study of Clinical Features and Treatment Patterns With Ustekinumab in... Background: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.Objective:To describe treatment patterns and clinical outcomes of patients with CD treated with ustekinumab in Japan.Methods: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 (International Classification of Disease, Tenth Revision [ICD-10] 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).Results: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.Conclusions: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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Annals of Pharmacotherapy SAGE

A Retrospective Cohort Study of Clinical Features and Treatment Patterns With Ustekinumab in Patients With Crohn Disease Utilizing a Health Care Database in Japan

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References (13)

Publisher
SAGE
Copyright
© The Author(s) 2023
ISSN
1060-0280
eISSN
1542-6270
DOI
10.1177/10600280221139245
Publisher site
See Article on Publisher Site

Abstract

Background: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.Objective:To describe treatment patterns and clinical outcomes of patients with CD treated with ustekinumab in Japan.Methods: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 (International Classification of Disease, Tenth Revision [ICD-10] 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).Results: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.Conclusions: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.

Journal

Annals of Pharmacotherapy – SAGE

Published: Sep 1, 2023

Keywords: Crohn disease; Japan; ustekinumab; complication; surgery

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